Strategies to Address Opioid Use Disorder and Co-Occurring Behavioral Health Disorders in Outpatient Treatment Settings

Transcription

1 Strategies to Address Opioid Use Disorder and Co-Occurring Behavioral Health Disorders in Outpatient Treatment Settings Dr. Julie Kmiec, DO Addiction Psychiatrist Medical Director, Ambulatory Detox Program Western Psychiatric Institute and Clinic Jack Warwick, MPH Project Coordinator Program Evaluation and Research Unit University of Pittsburgh

2 Learning Objectives 1. Review Medication Assisted Treatment (MAT) for Opioid Use Disorder (OUD); 2. Introduce approaches to manage behavioral health of patients with OUD; and 3. Present Project RAMP care management strategies.

3 Session 1: Medication Assisted Treatment Overview

4 Learning Objectives 1. Review the neuroscience behind MAT; 2. Introduce the medications for OUD treatment; 3. Present general treatment guidelines for naltrexone and buprenorphine; and 4. Describe the clinical implications of treating OUD in outpatient substance use disorder treatment settings.

5 Neuroscience of Opioid Use Disorder and MAT

6 Brain Reward Pathway 1 Mesolimbic dopamine system Controls response to natural rewards Dopaminergic neurons tell the body if something is rewarding or unpleasant Involves the memory centers

7 Opioids and the Brain Reward Pathway 2 Opioid receptors are part of the endorphin system Opioids activate opioid receptors releasing a surplus of dopamine Figure 1: The Dopamine Reward Pathway 3

8 Opioids Change Brain Chemistry Produces less dopamine and reduces the number of receptors 3 Amygdala becomes overactive 2 Frontal cortex becomes underactive 2 Impulse control diminishes 2 Withdrawal becomes the driving force of continued use 2

9 One may progress to diagnosable opioid use disorder (OUD) when at least two of the following DSM-V criteria are met within a 12-month period 4 : 1. Opioids are used more than originally planned 2. Persistent desire or unsuccessful efforts to reduce or control opioid use 3. Spending large amounts of time seeking, using, or recovering from opioid use 4. Craving to use opioids 5. Inability to complete daily responsibilities 6. Important social, occupation, or recreational activities are given up or reduced because of opioid use 7. Regularly using opioids in dangerous situations/environments 8. Continued opioid use despite negative physical or psychological effects 9. Develops tolerance 10. Evidence of withdrawal

10 Pharmacotherapy and MAT can successfully treat OUD by: Stabilizing abnormal brain activity 2 ; Reducing cravings and strengthening coping capacity 5 ; Allowing patients to focus on behavioral therapies 5 ; Increasing periods of abstinence and self-efficacy 5 ; and Improving clinical outcomes for patients and reducing impact on family and loved ones 5

11 Medications to Treat OUD

12 FDA Approved Medications to Treat OUD: Full Agonist Methadone Partial Agonist Buprenorphine Antagonist Naltrexone Source: TIP 40: Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction: Treatment Improvement Protocol (TIP) Series 40

13 Methadone

14 History of Methadone 2 Approved by the U.S. Food and Drug Administration to treat opioid addiction in 1972 Used as safe and effective treatment for opioids in the U.S. and worldwide

15 Methadone 2 Full mu-opioid receptor agonist Available through Opioid Treatment Programs (OTPs) only Dispensed daily initially, with the potential to progress to take home doses

16 Goals of Treatment 2 1. Eliminate cravings for opioids 2. Alleviate withdrawal symptoms 3. Block euphoric effects of self-administered opioids

17 Methadone Treatment Criteria 2 1. At least 1-year history of OUD (moderate-severe) except: Pregnant women/adolescents Previously treated patients (up to 2 years post-discharge) Those released from a correctional facility within the past 6 months 2. If under 18 Years Old: Two prior attempts at a drug-free psychosocial treatment within 12 months Written parental consent Pregnant

18 Dosing Induction Phase Weeks 1 & 2 of treatment Day 1: mg 2 Monitor 2-4 hours after Stability Phase mg 7 Goal: Ability to function without physical or psychological impairment 7

19 Buprenorphine

20 History of Buprenorphine Drug Addiction Treatment Act (DATA) allowed office-based physicians to treat OUD with controlled substances, schedule III-V 2002 FDA approved buprenorphine and buprenorphine/naloxone to treat opioid dependence

21 Physicians must have a DATA 2000 waiver to prescribe buprenorphine 8 DATA 2000 Waiver Qualification Requirements Physicians Licensed under state law; Registered with DEA to prescribe controlled substances; 8-Hour buprenorphine training; and Refer patients to counseling and other services; Physician Assistants and Nurse Practitioners Registered with DEA to prescribe controlled substance; 24 hours of required buprenorphine training; Be able to treat and manage OUD; and Work in collaboration with qualified physician (has DATA 2000 waiver) to prescribe medication to treat OUD if state requires physician oversight Waiver Training

22 Physicians without a waiver may use buprenorphine to treat acute withdrawal 9 Title 21 Code of Federal Regulations, Part b Three-Day Rule Physicians may administer narcotic drugs (i.e., buprenorphine) to relieve acute withdrawal symptoms Cannot extend past three days

23 Buprenorphine Formulations 2 Buprenorphine Subutex tabs Buprenorphine tabs Probuphine subdermal Buprenorphine/Naloxone Suboxone Film Bup/nx tabs Zubsolv Bunavail

24 Buprenorphine/Naloxone 2 Formulations available for buccal or sublingual administration: Buprenorphine- partial mu-opioid agonist Naloxone- opioid antagonist Effective when taken as directed due to poor bioavailability of naloxone when administered orally Addition of Naloxone minimizes risk of misuse by injection

25 Formulations 5 buprenorphine (generic) bup/nx (generic) SL tab x SL film Buccal film Suboxone x x Zubsolv Bunavail Probuphine Sublocade x x x Implant x Long-acting injectable x

26 Dose Equivalents of Sublingual and Buccal Formulations 5 buprenorphine (generic) Equivalent Buprenorphine Dose (Naloxone Dose Noted if Included in Formulation) 1 mg 2 mg 4 mg 8 mg 12 mg 16 mg 2 8 bup/nx (generic) 2/0.5 8/2 Suboxone (bup/nx) Zubsolv (bup/nx) Bunavail (bup/nx) 2/0.5 4/1 8/2 12/3 0.7/ / / / / / / / /1

27 Candidates for buprenorphine 2 : 1. Are currently physically dependent on opioids; 2. Have a history of opioid addiction (not currently dependent) and at high risk of relapse (e.g., incarcerated individuals); OR 3. Are currently on low dose methadone.

28 Buprenorphine Treatment Phases Induction start of treatment once patient has abstained from using opioids for 24 hours (at least 48 hours for methadone). 2. Stabilization determining appropriate dosing where patient no longer exhibits cravings/withdrawal. 3. Maintenance steady state dosing achieved and routine adjustments are no longer needed. Patient responding optimally to treatment and has stopped misusing opioids and other substances.

29 Induction Office-Based Administer dose and observe for withdrawal using Clinical Opiate Withdrawal Scale (COWS) 2-4 mg initial dose, 8 mg max on day #1 Follow up phone call/visit within week Home Patient given medication to take home Clinician provides written instructions on dosing, timing, and assessing withdrawal

30 Office-based induction allows the provider to 2 : Ensure the patient knows how to take the medication; Assess withdrawal and verify absence of precipitated withdrawal; and Enhance the therapeutic relationship.

31 Home induction may be used if the patient is able to 2 : Describe, understand, and assess withdrawal; Understand and follow dosing instructions; and Contact their provider about problems.

32 Induction Current Physical Dependence Must be in visible opioid withdrawal (typically COWS Score of 12 or higher) 2 Dose: 4-8 mg 11 Completed within a few days 2 The Clinical Opiate Withdrawal Scale (COWS)

33 A patient is in the stabilization phase once they have 2 : Significantly reduced or eliminated illicit opioid use; Blunted or blocked euphoria during illicit opioid use; Reduced opioid cravings; Suppressed opioid withdrawal; and Minimal side effects.

34 Adjusting Buprenorphine Dose 2 When to increase dose: If patients are taking doses correctly and they still experience: Opioid withdrawal Opioid craving Euphoria/ high from illicit opioid use When to decrease dose: Evidence of dose toxicity (i.e., sedation) Hold dose in cases of acute alcohol or benzodiazepine intoxication

35 Buprenorphine Maintenance 2 Goal- taper to lowest dose that can: Eliminate withdrawal; Reduce or eliminate opioid cravings; Reduce or eliminate euphoric effects of opioid use; and Be well tolerated. Typical Dose: 4-24 mg taken daily or rarely every other day

36 Buprenorphine Outpatient Treatment 2 Start by prescribing patient 1-week supply Advance to 2-week supply when patient is stable May advance up to a 30-day supply

37 Recommended Lab Testing 2,12,13 Pre-Treatment One-Month Post Treatment Initiation 3-Months Post 6-Months Post Annually Special Circumstances Urine Drug and Alcohol Test X Pregnancy Test X X X Liver Function Test X X X At each office appt. during first month of treatment and random tests after Every 2-3 months and post risky sexual encounter Hepatitis Tests X X HIV Tests X X Every 6-months for at risk groups CBC Test X X Chem 14 Panel X X

38 Efficacy of Buprenorphine 14

39 Efficacy of Buprenorphine 14 Controls 6 day buprenorphine taper Daily dosing of placebo and relapse prevention Buprenorphine 16 mg bup and relapse prevention

40 Methadone versus Buprenorphine Methadone Needs high level of monitoring Dependent on several substances History of diversion No insurance or limited means Buprenorphine Weekly visits/medication supply Not dependent on several substances Low risk of diversion Has insurance and means of payment

41 Naltrexone

42 History of Naltrexone FDA approved oral naltrexone to treat opioid dependence 1994 FDA approved oral naltrexone to treat alcohol dependence 2006 FDA approved XR-Naltrexone to treat alcohol dependence 2010 FDA approved XR-Naltrexone to treat opioid dependence

43 Naltrexone 2 Opioid antagonist Patient must be opioid free for 7-10 days (short-acting opioids and days (long-acting opioids) prior to induction

44 Candidates for naltrexone 2 : Do not want to take opioid agonists and/or did not respond well to prior agonist therapy; Have been opioid abstinent for at least one week; or Are a part of a program with external monitoring and have significant, immediate consequences for adherence (e.g., healthcare professionals, probationers, parolees).

45 Naltrexone Formulations 2 Oral Daily tablet XR-Naltrexone Monthly 380 mg IM injection

46 Initiating Naltrexone Treatment 2 Pre-Assessment Appointment 1. Collect Patient history 2. Physical examination 3. Administer necessary screens 4. Order Laboratory testing: Liver enzyme HIV Screen Hepatitis Panel Pregnancy Testing First Injection Appointment 1. Review screening/lab work 2. Naloxone/Naltrexone Challenge 3. Administer Injection 4. Schedule Follow-Up Appointment Within a week

47 Option 1: Naloxone Challenge Obtain baseline COWS, if 4 or less proceed to naloxone challenge (Intramuscular or Oral): Intramuscular 0.4 mg to deltoid and observe for 20 minutes for signs/symptoms of withdrawal 0.8 mg to other deltoid and observe for 20 minutes 2. If COWS increase is less than 2, proceed with extended-release injectable naltrexone administration.

48 Option 2: Naltrexone Challenge Obtain baseline COWS, if 4 or less proceed to naltrexone challenge: Oral 25 mg and observe for 60 minutes for signs/symptoms of withdrawal 2. If COWS increase is less than 2, proceed with extended-release injectable naltrexone administration.

49 Naltrexone Maintenance 1. Monthly Intramuscular Injection 2. Periodic Laboratory Testing

50 Recommended Lab Testing 2,12,13 Pre-Treatment One-Month Post Treatment Initiation 3-Months Post 6-Months Post Annually Special Circumstances Urine Drug and Alcohol Test X Before each initial injection and random tests after Pregnancy Test X X Liver Function Test X X X X Bi-monthly and post risky sexual encounter Hepatitis Tests X X HIV Tests X X Every 6-months for at risk groups

51 Naltrexone Randomized Controlled Trial 18

52 Naltrexone Randomized Controlled Trial 18 Double blind, placebo controlled, multi-center RCT of XR-naltrexone 13 sites in Russia

53 Naltrexone Randomized Controlled Trial 18

54 Naltrexone Randomized Controlled Trial 18

55 Naltrexone Randomized Controlled Trial 18

56 XR-Naltrexone versus Buprenorphine/Naloxone 19

57 XR-Naltrexone versus Buprenorphine/Naloxone 19 Norwegian randomized clinical trial lasting 12 weeks 159 patients in a clinical setting randomized to: injections of XR-naltrexone 380 mg every fourth week Buprenorphine/naloxone 4-24 mg SL administered daily Following induction, participants were asked to attend standard drug counseling At baseline and every 4 weeks thereafter, underwent a structured interview using the European version of the Addiction Severity Index

58 XR-Naltrexone versus Buprenorphine/Naloxone Primary outcome variables Retention in the study Proportion of total number of UDTs without illicit opioids Number of days of use of heroin and other illicit opioids 2. Secondary outcome variables Number of days of use of cannabis, amphetamines, cocaine, benzodiazepines, hallucinogens, alcohol Number of days of injecting (intravenous) drugs Degree of heroin craving, thoughts about heroin Satisfaction with treatment Mental health (Hopkins Symptom Checklist-25 of anxiety and depression, , with 25 indicating very low; 100, very high)

59 XR-Naltrexone versus Buprenorphine/Naloxone 19

60 Choosing between Naltrexone and Buprenorphine 20 Naltrexone Not able and/or not interested in agonist treatment Unsuccessful agonist treatment Highly committed to abstinence Detoxified, but at risk of relapse Less severe OUD Successful agonist treatment, but want to switch to antagonist treatment Buprenorphine History of overdoses Limited social supports Experience chronic pain and require chronic opioid treatment GI disorders that are exacerbated during abstinence Advanced liver disease

61 Clinical Implications of Treating OUD in Outpatient Settings

62 Thousands of Pennsylvanians do not receive treatment for their substance use disorders (SUDs) 21 In , 853,000 Pennsylvanians(18+) had alcohol or illicit drug dependence or misuse in the past year. 95% of those with alcohol dependence or misuse did not receive needed treatment. 84% of those with illicit drug dependence or misuse did not receive needed treatment.

63 One of the barriers to treatment is the separation of SUD treatment in specialty care centers 22

64 Integrating screening and treatment for SUDs in outpatient settings can help identify and initiate treatment. For example, in Primary Care and Emergency Departments

65 Primary care provides are an essential touch point for identifying individuals with SUD and OUD. About 80% of the population visit a primary care provider each year 23 20% of family medicine patients have an SUD % of patients in primary care settings who have been prescribed opioid therapy for chronic pain have OUD 25

66 Integrating primary care with SUD treatment is particularly important for meeting the needs of patients with co-occurring disorders. 45% of those seeking SUD treatment have been diagnosed with SUD and a co-occurring mental disorder 26

67 Similarly, emergency department (ED) providers are in the unique position to identify patients with OUD and initiate treatment. ED visits for opioid overdose increased by more than 50% in Pennsylvania between July 2016 and September

68 EDs can screen for SUD/OUD and use the Three-Day Rule to: 1. Initiate buprenorphine/naloxone treatment; and 2. Refer patients to buprenorphine-waivered primary care providers for enrollment in MAT.

69 ED-initiated buprenorphine/naloxone treatment has been successful. 28

70 Randomized Controlled Trial Methods 28 Randomized controlled trial at an urban teaching hospital ED from April June Opioid-dependent patients were randomized to the following groups: 1. Screening and referral to treatment (n=104) 2. Screening, brief intervention, and facilitated referral (n=111) 3. Screening, brief intervention, ED-initiated buprenorphine/naloxone, and referral to primary care for follow-up (n=114)

71 Randomized Controlled Trial Findings 28

72 The study found that ED-initiated buprenorphine/naloxone treatment 28 : 1. Increased engagement in addiction treatment; 2. Reduced self-reported illicit opioid use; and 3. Decreased use of inpatient addiction treatment.

73 Session 2: Managing Behavioral Health and OUD

74 Learning Objectives 1. Review role of counseling and behavioral therapies with MAT; 2. Present basic clinical management strategies for patients with co-occurring behavioral health disorders; and 3. Recommend best practice counseling approaches for OUD patients treated in outpatient settings.

75 Role of Counseling and Behavioral Therapies

76 Counseling is critical part of MAT and treating OUD. Counseling helps one to 2 : Improve problem solving and interpersonal skills; Develop techniques to resist drug use; Find incentives to reduce use and be abstinent; and Replace drug use with rewarding activities.

77 Counselors both 2 : 1. Work with patients taking OUD medication; and 2. Refer patients with OUD to healthcare professionals for treatment and medication.

78 Counselors vary 2 : In their titles, credentials, and responsibilities; Can work within the medical setting the patient receives treatment or work outside at a specialty addiction treatment center/program or even private practice.

79 There are many different types of counseling and behavioral therapies that are used in conjunction with MAT including 29 : Individual and Group Counseling; Recovery Support Services; Peer Supports; and 12-Step Fellowship.

80 Counseling and behavioral treatment should be individualized for each patient and should: 2 1. Target and address patients needs, beyond one s OUD; and 2. Supplement medication treatment.

81 Requiring Counseling 2 Counseling is required for certified opioid treatment programs. Medication Assisted Treatment (MAT) Law requires buprenorphine prescribers to be able to refer patients to counseling. FDA labels recommend counseling be a part of treatment with naltrexone and buprenorphine.

82 Studies find that counseling and behavioral therapies have many clinical benefits and should be a part of OUD treatment.

83 Patients receiving concurrent behavioral/psychosocial treatment with buprenorphine have: Higher rates of treatment retention, completion, and attendance 30 ; Reductions in opioid use 31 ; and Improved buprenorphine compliance 32.

84 Patients receiving concurrent behavioral/psychosocial treatment with XR-naltrexone have: Received more injections 33,34 ; Improved treatment retention 33,34 ; and Higher rates of treatment completion 34.

85 Counseling and behavioral therapies are even more important for SUD patients with co-occurring behavioral health disorders.

86 Co-Occurring Behavioral Health Disorders

87 SUD frequently occurs with mental illness million adults had a past year SUD % adults (roughly 8.2 million) had a co-occurring mental illness in the past year

88 There are three potential phenomenon causing SUD/Mental illness comorbidity: 1. Substance use/sud may cause symptoms of mental illness. 36,37,38,39 Early drug use can change the brain and increase the risk of mental illness. 2. Mental illness may lead to substance use and SUD. 40 Self-Medication 3. Both disorders share risk factors. 41,42,43,44 Genetic vulnerability Stress Trauma

89 Patients with SUD and co-occurring mental illness have poor health implications such as: Worse treatment outcomes 45 ; Higher relapse rates 46 ; More hospitalizations 47 ; Poorer quality of life 48 ; and High risk of suicide 49,50,51.

90 There are two different diagnoses for co-occurring mental illness 52 : 1. Independent; and 2. Secondary (substance-induced)

91 It is important to identify secondary/substance-induced mental illness because they may require a different treatment approach. 85% or more of substance-induced symptoms improve with abstinence. 43 Both primary and substance-induced depression predict future depression. 53

92 For a co-morbid diagnosis, it is important to establish a comprehensive approach that identifies, evaluates, and treats both disorders.

93 Managing Depression and SUD

94 Depression and SUD are associated with each other 54 Those with depression are 2x more likely to develop an SUD. Those with an SUD are 2x more likely to develop depression within their lifetime.

95 Many of those with SUD have had or currently suffer from depression 55, % of SUD patients have past depression % of SUD patients have current depression.

96 Opioid use symptoms mirror depression symptoms 57 Opioid Intoxication Apathy Dysphoria Psychomotor agitation or retardation Impaired memory and attention Opioid Withdrawal Insomnia Dysphoria Irritability

97 Most studies show that antidepressant treatment is effective for depressive disorders in those with comorbid SUD 58,59.

98 Pharmacotherapy for co-occurring depression 57 Selective serotonin reuptake inhibitors (SSRIs) should be the first line Serotonin and norepinephrine reuptake inhibitors (SNRIs) Tricyclic antidepressants (TCAs) Monoamine oxidase inhibitors Bupropion, mirtazapine, trazodone/nefazodone

99 Psychotherapy for co-occurring depression 57 Cognitive Behavioral Therapy (CBT) Interpersonal Psychotherapy

100 Managing Anxiety/Post Traumatic Stress Disorder (PTSD) and SUD

101 PTSD is highly prevalent, especially among those with OUD. 7-8 out of every 100 people will experience PTSD in their lifetime 60 33% of those with OUD have PTSD 61 Women and young adults are at greatest risk of severe PTSD and co-occurring OUD 62

102 Many of the symptoms of PTSD are similar to the symptoms of drug intoxication and withdrawal. Hyperarousal symptoms can be caused by opioid intoxication or withdrawal 57 Negative alteration in mood/cognition symptoms can also be caused by opioid use 57 Onset of symptoms after a traumatic experience and/or linked to recollections of the traumatic event, are likely secondary 63

103 There is little data addressing the treatment of comorbid OUD and PTSD 57 Pharmacological approaches for treating comorbid PTSD and SUD are limited to alcohol use disorder.

104 Pharmacotherapy for co-occurring PTSD 57 SSRIs should be the first line SNRIs Non-combat related PTSD TCAs and monoamine oxidase inhibitors Intrusive and depressive symptoms Prazosin PTSD-related nightmare and sleep disturbances.

105 Psychotherapy for co-occurring PTSD 57 Cognitive Behavioral Therapy (CBT) Seeking Safety

106 CBT for PTSD is evidence-based and involves a combination of 64 : Psychoeducation; Relaxation and anxiety management techniques; Cognitive techniques; Imagined and in vivo exposure to trauma-related stimuli; and Relapse prevention.

107 Seeking Safety is standard cognitive behavioral treatment with both trauma/safety and substance use components which: Reduces substance use 65 ; Reduces PTSD symptoms 65 ; and Results in positive outcomes across studies. 66

108 Managing Attention Deficit Hyperactivity Disorder (ADHD) and SUD

109 ADHD and SUD frequently co-occur. 8-13% of those in SUD treatment have ADHD. 67,68,69, % of patients with OUD have ADHD. 71,72

110 OUD symptoms can mimic ADHD symptoms. 57 Acute Opioid Effects Agitation Impaired concentration Opioid Withdrawal Restlessness Irritability Agitation

111 Research on treatment for comorbid ADHD and SUD and OUD is limited. Medications that are effective for adult ADHD are likely to be effective. 73

112 Pharmacotherapy for co-occurring ADHD 1. Atomoxetine should be the first line Bupropion 57 Off-label use 3. Guanfacine, modafinil, TCAs (off-label use) Stimulants, including: Methylphenidate and related compounds Fewer patient-reported ADHD symptoms 74

113 Psychotherapy for co-occurring ADHD 57 ADHD Cognitive Behavioral Therapy (CBT) Organizational coaches SUD Individual and group psychotherapy Self-help Family therapy

114 Session 3: Best Practice Counseling Approaches for Outpatient Settings

115 Psychosocial Treatment and Pharmacotherapy for OUD

116 DATA 2000 Allows for office based treatment of OUD with Schedule III-V drugs if Physician: Completes 8 hours of training (more for PA-C and CRNP) Has no more than 30 patients at one time in first year Is registered with DEA Must be capable of referring patients to counseling and other services

117 Barriers to Prescribing Buprenorphine Hutchinson E, Catlin M, Andrilla CH, Baldwin LM, Rosenblatt RA. Barriers to primary care physicians prescribing buprenorphine. Ann Fam Med Mar-Apr;12(2): PubMed PMID:

118 Barriers Rural Physicians Face Andrilla CHA, Coulthard C, Larson EH. Barriers Rural Physicians Face Prescribing Buprenorphine for Opioid Use Disorder. Ann Fam Med Jul;15(4): PubMed PMID:

119 PCP Role Coordinate care Provide therapeutic alternatives Shared decision-making Follow-up to ensure attendance, working towards goals, and response to treatment Renegotiate treatment as needed

120 Goals of Psychosocial Treatment Educate about addiction, treatment, and recovery Help manage cravings Help motivate participants to reduce or stop substance use Improve functioning and quality of life Address underlying issues that contribute to or reinforce substance use Develop coping skills Encourage medication adherence Relapse prevention skills Treat co-occurring disorders that may contribute to relapse

121 ASAM Criteria- Levels of Care Inpatient Medically managed rehab 24 hour nursing care, daily physician visits, counselor availability Residential rehab Short-term 24 hour nursing care with physician availability and 16 hours counselor availability Extended 24 hour care with trained counselors to stabilize and prepare for outpatient Halfway house 24 hour structure with at least 5 hours of service per week Outpatient Partial hospitalization 20 or more hours per week Intensive outpatient - at least 9 hours per week (6 or more for adolescents) Outpatient therapy (individual and/or group) - less than 9 hours per week (less than 6 hours per week for adolescents)

122 Common Modalities of Psychosocial Treatment Contingency management Relapse prevention Motivational interviewing 12-step facilitation

123 Contingency Management (CM) CM uses operant conditioning, which uses systematically applied environmental consequences increase (reinforce) or decrease (punish) behaviors If a substances make someone feel good, it may reinforce the substance use: substance use may have negative consequences which may decrease likelihood of continued use (e.g., relationship problems, legal consequences, illness from use)

124 Contingency Management (CM) Example of voucher-based CM program Written contract stipulating all aspects of the CM intervention Vouchers are contingent upon negative urine toxicology, urines done 3x/week Vouchers exchanged for retail items Program last 12 weeks First negative specimen earns a voucher worth $2.50, value of each subsequent specimen increases by $1.25 $10 bonus is provided for each three consecutive negative specimens in order to reinforce continuous abstinence Positive specimen or failure to provide specimen resets vouchers to $2.50 (punishment) To incentivize patients to abstain after a reset, submitting five consecutive negative specimens after a positive specimen returns to voucher value prior to reset. Someone who provides all negative specimens for the 12 weeks, would earn $ Earnings in most cases are about ½ of that maximum

125 Relapse Prevention (RP) Cognitive-behavioral skills addressing intra- and interpersonal variables and risk factors for relapse Develop effective coping strategies to help individual maintain desired behavioral changes The ASAM Principles of Addiction Medicine (2014)

126 RP Interventions Help patients understand relapse as a process and event, and learn to identify warning signs identify high-risk situations and develop effective cognitive and behavioral coping enhance their communication skills and interpersonal relationships and develop a recovery social network reduce, identify, and manage negative emotional states

127 RP Interventions Help patients identify cues that precede cravings and manage cravings identify and challenge cognitive distortions work toward a more balanced lifestyle Consider the use of medications in combination with psychosocial treatment

128 Motivational Interviewing Ambivalence about making changes is normal and presents an obstacle in recovery Resolve ambivalence by enhancing intrinsic motivations and values Build a collaborative partnership, recognizing both bring expertise Create an empathic, supportive, yet directive, counseling style to facilitate change (recognize arguing and confrontation may increase defensiveness and reduce the likelihood of change) Goal is to elicit change talk and behavior changes by creating discrepancy to enhance motivation

129 12-Step Facilitation (TSF) Structured, individual, manual-guided approach Core topics (e.g., assessment and overview, acceptance, surrender, and getting active) covered with all patients Elective topics to tailor treatment to the individual (e.g., people, places, and things; enabling) Each session begins with a review of the previous week, meeting attendance, review of the patient's recovery journal, and reactions to any 12-step readings assigned Therapist introduces recovery topic from the core and elective sessions End session with recovery tasks to do out of session (e.g., meetings to attend, self-help readings)

130 Psychosocial services with methadone maintenance 92 men with OUD at VAMC Randomly assigned for 6 months to 1 of 3 treatment groups: 1. minimum methadone services (MMS) - at least 60 mg/d of methadone alone with no other services 2. standard methadone services (SMS) - at least 60 mg/d of methadone plus counseling 3. enhanced methadone services (EMS) - at least 60 mg/d of methadone plus counseling and on-site medical/psychiatric, employment, and family therapy McLellan AT, Arndt IO, Metzger DS, Woody GE, O Brien CP. The effects of psychosocial services in substance abuse treatment. JAMA. 1993; 269: [PubMed: ]

131 Psychosocial services with methadone maintenance Methadone alone (MMS) was associated with reductions in opiate use 69% of MMS patients had to be "protectively transferred" from the trial because of continued use of opiates or cocaine, or medical/psychiatric emergencies These patients were transferred to SMS and had significant reductions in opioid and cocaine use in 4 weeks 41% of standard SMS subjects and 19% of EMS subjects had to be protectively transferred McLellan AT, Arndt IO, Metzger DS, Woody GE, O Brien CP. The effects of psychosocial services in substance abuse treatment. JAMA. 1993; 269: [PubMed: ]

132 Psychosocial services with methadone maintenance At 24 weeks, completed Addiction Severity Index: There was minimal improvement among the 10 MMS patients who completed the trial (improvement in the drug-use factor score and a decrease in the number of days of opiate use) SMS group showed significantly more and larger improvements than did the MMS group (significant decreases in opiate and cocaine use, legal, family, and psychiatric problems) EMS group showed significantly better outcomes than did the SMS group (significant improvement in employment status, decreased substance use, legal, family, and psychiatric problems) McLellan AT, Arndt IO, Metzger DS, Woody GE, O Brien CP. The effects of psychosocial services in substance abuse treatment. JAMA. 1993; 269: [PubMed: ]

133 Do you see similar effects for buprenorphine and naltrexone?

134 Psychosocial treatment plus maintenance Cochrane review of 35 studies, 4319 participants, using thirteen different psychosocial interventions for participants in opioid agonist treatment The addition of psychosocial support (including contingency management) to maintenance treatment did not add benefit to: Retention Abstinence Psychiatric symptoms Amato L, Minozzi S, Davoli M, Vecchi S. Psychosocial combined with agonist maintenance treatments versus agonist maintenance treatments alone for treatment of opioid dependence. Cochrane Database Syst Rev. 2011; (10):CD [PubMed: ]

135 Medical management and buprenorphine RCT with 166 primary care patients assigned to 1 of 3 conditions: standard medical management with once-weekly medication dispensing standard medical management with thrice-weekly medication dispensing enhanced medical management with thrice-weekly medication dispensing Standard medical management: brief, manual-guided, medically focused counseling Enhanced medical management: extended, manual-guided, medically focused counseling Primary outcome measures: self-reported frequency of illicit opioid use percentage of opioid-negative urines maximum number of consecutive weeks of abstinence from illicit opioids Fiellin DA, Pantalon MV, Chawarski MC, et al. Counseling plus buprenorphine-naloxone maintenance therapy for opioid dependence. N Engl J Med. 2006; 355: [PubMed: ]

136 * * Fiellin DA, Pantalon MV, Chawarski MC, et al. Counseling plus buprenorphine-naloxone maintenance therapy for opioid dependence. N Engl J Med. 2006; 355: [PubMed: ]

137 Psychosocial treatment and buprenorphine RCT with 202 participants with OUD who were stabilized on buprenorphine (weeks 1-2), then randomized to 1 of 4 psychosocial treatment conditions which lasted for 16 weeks, followed by a 16 week medication only phase: 1. cognitive behavioral therapy (CBT; N = 53) 2. contingency management (CM ; N = 49) 3. CBT + CM (N = 49) 4. no additional behavioral treatment (NT; N = 51) Outcome measures: opioid use (proportion of negative urines = treatment effectiveness score [TES]) Retention, cravings, withdrawal symptoms

138

139

140 Buprenorphine in primary care +/- CBT 141 primary care patients in treatment for opioid use disorder enrolled in a 24-week randomized clinical trial: Randomized to: physician management (PM) brief, manual guided, and medically focused physician management plus CBT (PM + CBT) manual guided CBT for first 12-weeks Outcome measures: self-reported frequency of illicit opioid use maximum number of consecutive weeks of abstinence from illicit opioids (based on urine toxicology and self-report) Fiellin DA, Barry DT, Sullivan LE, Cutter CJ, Moore BA, O'Connor PG, Schottenfeld RS. A randomized trial of cognitive behavioral therapy in primary care-based buprenorphine. Am J Med Jan;126(1):74.e11-7. doi: /j.amjmed PubMed PMID: ; PubMed Central PMCID: PMC

141 Buprenorphine in primary care +/- CBT PM and PM+CBT were similarly effective: Reduced self-reported frequency of opioid use, from 5.3 days per week (95% CI, ) at baseline to 0.4 (95% CI, ) at follow-up (P=0.96) No difference between groups in maximum consecutive weeks of opioid abstinence (P=0.84) Retention was similar in groups (P=0.43) PM 45% retention PM + CBT 39% retention Study did not support the routinely adding CBT to PM in patients receiving buprenorphine in primary care. Fiellin DA, Barry DT, Sullivan LE, Cutter CJ, Moore BA, O'Connor PG, Schottenfeld RS. A randomized trial of cognitive behavioral therapy in primary care-based buprenorphine. Am J Med Jan;126(1):74.e11-7. doi: /j.amjmed PubMed PMID: ; PubMed Central PMCID: PMC

142 Buprenorphine in primary care +/- CBT by opioid type Study comparing patients with opioid use disorder who had a history of heroin vs. prescription opioid use No differences in the abstinence from opioids and treatment retention based on opioid type Opioid type moderated the effect of CBT on abstinence from all substances Patients with history of prescription opioid use assigned to PM + CBT had a longer period of abstinence from all drugs (7.6 wks) than those assigned to PM only (3.6 wks; p=.02); patients with history of heroin use did not differ by treatment Moore BA, Fiellin DA, Cutter CJ, Buono FD, Barry DT, Fiellin LE, O'Connor PG, Schottenfeld RS. Cognitive Behavioral Therapy Improves Treatment Outcomes for Prescription Opioid Users in Primary Care Buprenorphine Treatment. J Subst Abuse Treat Dec;71: PubMed PMID:

143 Prescription Opioids Treatment Study (POATS) 10-site NIDA CTN RCT N=653 (77% exclusively PO-dependent, 23% had h/o minimal, non-injection heroin use) Standard MM Standard MM + Individual Drug Counseling (1-2x/week) Different lengths of buprenorphine treatment Started with a less intensive treatment, switched to a more intensive treatment if needed Weiss RD, Potter JS, Fiellin DA, Byrne M, Connery HS, Dickinson W, Gardin J, Griffin ML, Gourevitch MN, Haller DL, Hasson AL, Huang Z, Jacobs P, Kosinski AS, Lindblad R, McCance-Katz EF, Provost SE, Selzer J, Somoza EC, Sonne SC, Ling W. Adjunctive counseling during brief and extended buprenorphine-naloxone treatment for prescription opioid dependence: a 2-phase randomized controlled trial. Arch Gen Psychiatry Dec;68(12): PubMed PMID:

144 Prescription Opioids Treatment Study (POATS) Medical Management: Overall health check Urine monitoring Check on medication: efficacy, adherence, tolerability Monitor craving Advice to abstain Advice to attend mutual-help groups Opioid Drug Counseling: Education about addiction and recovery Recommended mutual-help groups Emphasized lifestyle change Interactive exercises and take-home assignments for relapse prevention (e.g., coping with high-risk situations, managing emotions, and dealing with relationships) Weiss RD, Potter JS, Fiellin DA, Byrne M, Connery HS, Dickinson W, Gardin J, Griffin ML, Gourevitch MN, Haller DL, Hasson AL, Huang Z, Jacobs P, Kosinski AS, Lindblad R, McCance-Katz EF, Provost SE, Selzer J, Somoza EC, Sonne SC, Ling W. Adjunctive counseling during brief and extended buprenorphine-naloxone treatment for prescription opioid dependence: a 2-phase randomized controlled trial. Arch Gen Psychiatry Dec;68(12): PubMed PMID:

145 POATS Study Design 7% 49% 9% Weiss RD, Potter JS, Fiellin DA, Byrne M, Connery HS, Dickinson W, Gardin J, Griffin ML, Gourevitch MN, Haller DL, Hasson AL, Huang Z, Jacobs P, Kosinski AS, Lindblad R, McCance-Katz EF, Provost SE, Selzer J, Somoza EC, Sonne SC, Ling W. Adjunctive counseling during brief and extended buprenorphine-naloxone treatment for prescription opioid dependence: a 2-phase randomized controlled trial. Arch Gen Psychiatry Dec;68(12): PubMed PMID:

146 POATS Results Weiss RD, Potter JS, Fiellin DA, Byrne M, Connery HS, Dickinson W, Gardin J, Griffin ML, Gourevitch MN, Haller DL, Hasson AL, Huang Z, Jacobs P, Kosinski AS, Lindblad R, McCance-Katz EF, Provost SE, Selzer J, Somoza EC, Sonne SC, Ling W. Adjunctive counseling during brief and extended buprenorphine-naloxone treatment for prescription opioid dependence: a 2-phase randomized controlled trial. Arch Gen Psychiatry Dec;68(12): PubMed PMID:

147 POATS Secondary Study Are there subgroups of patients who respond to counseling? Patients with history of using heroin (vs. prescription opioids alone) Patients who had ever used heroin and received drug counseling were more likely to be abstinent or nearly abstinent from opioids than those who received medical management alone, if they were adherent to treatment (OR=3.7, 95% CI= , p=0.03). Weiss RD, Griffin ML, Potter JS, Dodd DR, Dreifuss JA, Connery HS, Carroll KM. Who benefits from additional drug counseling among prescription opioid-dependent patients receiving buprenorphine-naloxone and standard medical management? Drug Alcohol Depend Jul 1;140: PubMed PMID:

148 Thoughts Regarding Negative Results for Psychosocial Treatment: MM is more intensive than community standard Subjects in studies received higher doses (24-32 mg) of buprenorphine than used in community (<16 mg) Are the outcome measures (negative urine tests, retention) in studies the only ways to judge success of treatment? Stable housing Employment Absence of criminal activity Medical and psychiatric outcomes

149 Naltrexone with contingency management RCT with 171 patients recently detoxified from opioids, started on naltrexone assigned to 1 of 3 conditions for 12 weeks: Standard naltrexone treatment (dosed 3x/week) Naltrexone plus contingency management (CM) Received vouchers for ingestion of medication and negative urine specimens (max $561) Naltrexone plus contingency management with significant other involvement CM as above plus up to 6 sessions with a significant other All groups received weekly group CBT Outcome measures: retention in treatment, adherence to treatment, number of drug free urines Carroll KM, Ball SA, Nich C, O'Connor PG, Eagan DA, Frankforter TL, Triffleman EG, Shi J, Rounsaville BJ. Targeting behavioral therapies to enhance naltrexone treatment of opioid dependence: efficacy of contingency management and significant other involvement. Arch Gen Psychiatry Aug;58(8): PubMed PMID:

150 Carroll KM, Ball SA, Nich C, O'Connor PG, Eagan DA, Frankforter TL, Triffleman EG, Shi J, Rounsaville BJ. Targeting behavioral therapies to enhance naltrexone treatment of opioid dependence: efficacy of contingency management and significant other involvement. Arch Gen Psychiatry Aug;58(8): PubMed PMID:

151 Carroll KM, Ball SA, Nich C, O'Connor PG, Eagan DA, Frankforter TL, Triffleman EG, Shi J, Rounsaville BJ. Targeting behavioral therapies to enhance naltrexone treatment of opioid dependence: efficacy of contingency management and significant other involvement. Arch Gen Psychiatry Aug;58(8): PubMed PMID:

152 Naltrexone plus behavioral family counseling 124 male patients with OUD randomized to 1 of 2 conditions for 24 weeks: Individual based treatment (IBT) - started on naltrexone, asked about adherence in sessions Behavioral family counseling (BFC) - started on naltrexone, family observed ingestion Counseling 3 times per week for 16 weeks, then 1 session weekly for last 8 weeks IBT had two 60-min individual sessions, one 90-min group session BFC had one 60-min individual session, one 60-min family session, one 90-min group session Last 8 weeks, each group had only one 60-min individual session Fals-Stewart W, O'Farrell TJ. Behavioral family counseling and naltrexone for male opioid-dependent patients. J Consult Clin Psychol Jun;71(3): PubMed PMID:

153 Naltrexone plus behavioral family counseling Study was 24 weeks but conducted follow-up visits every 3 months for 1 year. Outcome measures: Abstinence from opioids Adherence to naltrexone Retention in treatment Abstinence from other substances Fals-Stewart W, O'Farrell TJ. Behavioral family counseling and naltrexone for male opioid-dependent patients. J Consult Clin Psychol Jun;71(3): PubMed PMID:

154 Fals-Stewart W, O'Farrell TJ. Behavioral family counseling and naltrexone for male opioid-dependent patients. J Consult Clin Psychol Jun;71(3): PubMed PMID:

155 Fals-Stewart W, O'Farrell TJ. Behavioral family counseling and naltrexone for male opioid-dependent patients. J Consult Clin Psychol Jun;71(3): PubMed PMID:

156 Mutual Support Groups Mutual Support Groups are a complement to treatment. Examples: 12-step (NA, AA, MA, etc.) Secular Organizations for Sobriety SMART recovery - uses CBT and MI as tools to support those who desire to abstain from substances or behavioral addiction

157 Those on medications such as methadone and buprenorphine are free to attend meetings It is up to individual NA group whether those on medications are encouraged to share during meeting or hold offices AT_1021.pdf; Accessed 6/11/18

158 Study of mutual support groups and buprenorphine 300 African-Americans, in one of two clinics started buprenorphine, previously had been abstinence-based counseling Programs provided mostly group counseling 5 days per week, on-site buprenorphine dosing 5-6 days per week, with possibility to receive weekly, biweekly, and monthly prescriptions Both clinics encouraged 12-step meeting attendance, one clinic had an onsite meeting, some were required to attend Outcome measures: retention in treatment, abstinence, plus qualitative data regarding involvement in 12-step, regarding experiences and disclosure Monico LB, Gryczynski J, Mitchell SG, Schwartz RP, O'Grady KE, Jaffe JH. Buprenorphine Treatment and 12-step Meeting Attendance: Conflicts, Compatibilities, and Patient Outcomes. J Subst Abuse Treat Oct;57: doi: /j.jsat Epub 2015 May 12. PubMed PMID:

159 Study of mutual support groups and buprenorphine Outcome measures Abstinence at 6 months based on self-report of use in past month and urine Retention at 6 months NA experiences Helpfulness of meetings (rated 1-5) Required to attend meetings (yes/no) Number of meetings attended Disclosure of buprenorphine treatment at meetings (yes/no) Acceptance of buprenorphine at meetings (e.g., advised to taper or decrease dose) Extent of feeling like not "clean" based on meeting (1-5) Attendance at counseling services Monico LB, Gryczynski J, Mitchell SG, Schwartz RP, O'Grady KE, Jaffe JH. Buprenorphine Treatment and 12-step Meeting Attendance: Conflicts, Compatibilities, and Patient Outcomes. J Subst Abuse Treat Oct;57: doi: /j.jsat Epub 2015 May 12. PubMed PMID:

160 Study of mutual support groups and buprenorphine 76% reported that their counselor required NA attendance At 6 month follow-up, of participants who attended NA meetings within the past 3 months 67% said that NA meetings were quite a bit or extremely helpful to their recovery 5% reported that NA meetings were not at all helpful 33% disclosed they were on buprenorphine Out of this group, 26% stated someone at NA encouraged them to stop or decrease dose Mean meeting attendance of participants in treatment at 6 months was significantly greater than participants who dropped out (71.9 vs meetings; p<.001) Monico LB, Gryczynski J, Mitchell SG, Schwartz RP, O'Grady KE, Jaffe JH. Buprenorphine Treatment and 12-step Meeting Attendance: Conflicts, Compatibilities, and Patient Outcomes. J Subst Abuse Treat Oct;57: doi: /j.jsat Epub 2015 May 12. PubMed PMID:

161 Study of mutual support groups and buprenorphine At 6 month follow-up, of participants who attended NA meetings within the past 3 months: Patients abstinent at 6 months had significantly higher meeting attendance during the prior 6 months than those who were not abstinent (80.1 vs meetings; p <.001) No difference in the number of NA meetings attended for those with meeting requirement (61.3) than those without such requirement (50.8; p=0.14) Monico LB, Gryczynski J, Mitchell SG, Schwartz RP, O'Grady KE, Jaffe JH. Buprenorphine Treatment and 12-step Meeting Attendance: Conflicts, Compatibilities, and Patient Outcomes. J Subst Abuse Treat Oct;57: doi: /j.jsat Epub 2015 May 12. PubMed PMID:

162 Study of mutual support groups and buprenorphine Qualitative results (14 of 20 participants discussed buprenorphine disclosure): 5 did not disclose being on buprenorphine under any circumstances 5 always disclosed they were taking buprenorphine 4 disclosed taking buprenorphine circumstantially Monico LB, Gryczynski J, Mitchell SG, Schwartz RP, O'Grady KE, Jaffe JH. Buprenorphine Treatment and 12-step Meeting Attendance: Conflicts, Compatibilities, and Patient Outcomes. J Subst Abuse Treat Oct;57: doi: /j.jsat Epub 2015 May 12. PubMed PMID:

163 Monico LB, Gryczynski J, Mitchell SG, Schwartz RP, O'Grady KE, Jaffe JH. Buprenorphine Treatment and 12-step Meeting Attendance: Conflicts, Compatibilities, and Patient Outcomes. J Subst Abuse Treat Oct;57: doi: /j.jsat Epub 2015 May 12. PubMed PMID:

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