Naltrexone Overview. Todd Korthuis, MD, MPH ECHO-MAT Conference November 7, 2017
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1 Naltrexone Overview Todd Korthuis, MD, MPH ECHO-MAT Conference November 7, 2017
2 Disclosure Information Speaker/Planner: Todd Korthuis, MD, has nothing to disclose. 2
3 Pharmacotherapy for Opioid Use Disorder % Mu Receptor Intrinsic Activity Full Agonist: Methadone ( How High ) Partial Agonist: Buprenorphine 10 0 no drug low dose Drug Dose Antagonist : Naltrexone high dose ( How Much )
4 Naltrexone for Opioid Use Opioid antagonist Blocks opioid μ, κ, and δ receptors Requires patient fully detoxified Oral formulation 50mg once daily Effective for treatment retention & opioid abstinence 1 Few drug-drug interactions 2 No CYP 450 metabolism Disorder Poor adherence limits effectiveness 1 Minozzi Cochrane McCance-Katz 2001
5 XR-Naltrexone for Opioid Dependence Intramuscular injection lasts 28d Efficacious compared to placebo: Comer: 60 U.S. heroin users at 8 weeks 1 Krupitsky: 250 Russian heroin users at 24 wks 2 Non-inferior to buprenorphine for decreasing opioid use at 12 wks 3 Also effective for treatment of alcohol dependence 4 1 Comer Arch Gen Psych Krupitsky Lancet Tanum JAMA Psychiatry Garbutt JAMA 2005
6 Naltrexone Safety Minor side effects in treatment of alcohol and opioid dependence 1 Long-term mortality comparable to BUP/NX, Methadone in Australian cohort studies 2 Limited hepatotoxicity VA Data No increased hepatotoxicity 3 Russian RCT (42% HIV+, 88% HCV+) No difference in SAE or liver enzyme elevation by HIV or HCV status 4, 5 1 Lobmaier Reece Tetrault Krupitsky Mitchell McCance-Katz 2001
7 After 6 months Relapse: 43% Naltrexone 64% Usual Treatment Overdoses: 0 Naltrexone 7 Usual Treatment Lee NEJM
8 CTN-0055 Pilot Study HIV Clinic-based XR-NTX vs. TAU for 51 HIV patients with OUD and/or AUD XR-NTX acceptable to patients and providers XR-NTX TAU Treatment Initiation OUD (n=24) 42% 100% AUD (n=27) 92% 93% Treatment Retention OUD (n=17) 100% 50% AUD (n=24) 83% 50% Core Center Stroger Cook County Hospital Chicago, IL Korthuis, Lum, et al Addiction 2017 St. Paul s Hospital University of British Columbia Vancouver, BC
9 XR-NTX Induction General Principles Induction procedures will vary based on: Individual patient s medical needs Clinician s comfort level All patients should be advised regarding potential for precipitated withdrawal if they have recently taken opioids 9
10 Goal of XR-NTX Induction To safely initiate XR-NTX Avoid precipitated withdrawal Avoid opioid relapse prior to XR-NTX dosing 10
11 Tailoring XR-NTX Induction to Patient 1. Alcohol use disorder and no recent opioid use 2. Opioid use disorder and no recent opioid use 3. Opioid and/or alcohol use disorder with recent opioid use 11
12 XR-NTX Induction Alcohol use disorder and no recent opioid use Proceed directly to XR-NTX, if: Negative self-report of opioid use, and UDS negative for opioids If in doubt, perform naloxone challenge 12
13 XR-NTX Induction Opioid use disorder and no recent opioid use Proceed to XR-NTX when: Negative self-report of opioid use UDS negative for opioids Negative naloxone challenge Preferred, but may be omitted per clinician discretion (e.g. patient enrolling on release from jail) 13
14 14 XR-NTX Induction Opioid and/or alcohol use disorder with recent opioid use: Always requires naloxone challenge Tailor to level of anticipated opioid withdrawal Mild Non-opioid medications for symptom management Moderate-Severe Non-opioid medications for symptom management Opioid-Assisted Detox Buprenorphine May consider outpatient home detox Methadone
15 Streamlined Naltrexone Induction Procedures 5-Day Columbia Induction Protocol* Bup/nx Oral Naltrexone XR- Naltrexone Withdrawal Prophylaxis Monday 2mg-8mg - - Supportive Meds Tuesday - - Supportive Meds Wednesday - 1-3mg - Supportive Meds Thursday mg - Supportive Meds Friday - 25mg 380mg im Supportive Meds *Sullivan, Bisaga, & Nunes, AJP 2017
16 Extended-Release Naltrexone Directions for Use
17 The XR-NTX Kit 17 One vial of XR-NTX microspheres One vial of diluent One 5-mL syringe One 1-inch 20-gauge preparation needle Two 1.5-inch 20-gauge administration needles with aqua needle protection device Two 2-inch 20-gauge administration needles with orange needle protection device
18 XR-NTX Storage XR-NTX should be stored refrigerated at temperatures 2 8 C, F, not frozen Unrefrigerated XR-NTX can be stored at room temperature 7 cumulative days prior to administration
19 XR-NTX Preparation Must be prepared and administered by a healthcare professional Visual inspection for particulate matter and discoloration prior to administration Do not substitute for the components in the carton Remove from refrigerator for at least 45 minutes prior to administration, and allowed to reach room temperature Use the preparation needle to add the diluent to the microspheres vial Mix powder and diluent by shaking vial vigorously for approximately 1 minute, ensuring the dose is thoroughly suspended
20 XR-NTX Preparation (Continued) Administer immediately after reconstitution Withdraw suspension immediately into the syringe using same preparation needle Replace preparation needle with one of the administration needles provided (1.5 inches or 2 inches) Body habitus: assure that proper needle is selected and that the needle length is adequate for intramuscular administration Inadvertent subcutaneous injection of XR-NTX may increase likelihood of severe injection site reactions Prepare 4.2 ml of suspension to administer 4 ml immediately by deep intramuscular (IM) injection into the upper, outer quadrant of the gluteal muscle Dispose of used and unused items in proper waste containers
21 XR-NTX Administration XR-NTX given as an IM gluteal injection every 4 week Inject into the upper, outer quadrant of the buttock, deep into the muscle The buttock should be alternated per monthly injection XR-NTX must not be administered intravenously, subcutaneously, or in the adipose layer. Remember to aspirate for blood before injection. Should be administered with caution to patients with thrombocytopenia or any coagulation disorder
22 What Could Possibly Go Wrong? Precipitated Opioid Withdrawal Sudden onset of new diaphoresis, papillary dilatation, restlessness, rhinorrhea, arthralgias, vomiting, diarrhea, tremor, anxiety/irritability, or piloerection Needle clogging Firm pressure Switch needles is needed Can be avoiding by administering at room temp immediately Post-injection nausea Injection site reaction
23 Risk of Precipitated Withdrawal % Mu Receptor Intrinsic Activity Full Agonist (e.g. heroin) 70 ( How High ) Partial Agonist (e.g. buprenorphine) no drug low dose Antagonist (e.g naltrexone) high dose 23 Drug Dose ( How Much )
24 24 Management of Precipitated Withdrawal Prevention Counseling participant Wait 7-10 days since last dose of opioids Naloxone challenge Symptoms typically mild when UDS negative Treat as with any opioid withdrawal Fluids Clonidine NSAIDS Anti-emetics Anti-diarrheals Benzodiazepines
25 Re-Induction onto XR-NTX Within 35 days of the previous dose Usually safe regardless of UDS or selfreported recent use since NTX blockade effective up to 35 days Beyond 35 days since previous dose Risk of re-developing physical dependence increased Negative opioid UDS required Naloxone challenge (if clinically indicated) 25
26 Thank You
27 Supplemental Slides
28 Naloxone Challenge why? A more comfortable XR-NTX induction Performed to confirm the absence of opioids The presence of opioids during naltrexone induction may precipitate uncomfortable withdrawal symptoms 28
29 Naloxone Challenge: Method Dose: min total 0.8 mg naloxone Preferred route: 1) IV, 2) SC, 3) IM, or 4) IN Observe for opioid withdrawal at least 10 minutes when IV 30 minutes when SC, IM, or IN Positive naloxone challenge: onset of new opioid withdrawal symptoms and/or signs of worsening symptoms COWS flow sheet 29
30
31 Positive Naloxone Challenge Provide non-opioid medications to treat withdrawal symptoms. Encourage patient to continue to abstain from opioids. Have patient return daily for repeat UDS and naloxone challenge until both are negative. 31
32 Negative Naloxone Challenge If opioid withdrawal symptoms do not worsen or emerge following the naloxone challenge Proceed to XR-NTX administration 32
33 Provider Acceptance of XR-NTX Survey results from 107 providers in 12 HIV clinics 22% of providers said they currently intend to recommended XR-NTX Intent to Recommend XR-NTX Associated with: For Opioid Use Disorder aor (95% CI) For Alcohol Use Disorder aor (95% CI) High belief medication is effective 8.5 (1.6, 44.3) 9.2 (2.3, 36.5) Buprenorphine waiver 5.3 (1.3, 21.6) 1.06 (0.27, 4.08) High social norm 16.5 (3.9, 68.9) 5.3 (1.6, 17.2) Korthuis AMERSA abstract 2014
34 Patient Acceptability Survey of 657 community-based injection opioid users, Vancouver, BC 1 52% Willing to try XR-NTX for opioid use disorder Prescreening of 113 patients: 98% opioid users (n=60), 100% risky alcohol users (n= 82) were definitely or maybe willing to participate in a trial of XR-NTX. 1 Ahamad, Korthuis 2015 ASCP
35 Role of Buprenorphine for Naltrexone Induction (Moderate-Severe Withdrawal, Brief taper) Day 1 Day 2 Day 3 Buprenorphine Dose 4mg, repeat to total of 8-16mg Half of day 1 dose Half day 2 dose Wait 1-3 days for naloxone challenge Non-opioid meds for symptom relief 35
36 Role of Buprenorphine for Induction (Moderate-Severe Withdrawal, 7-day taper) Buprenorphine Dose Day 1 4mg, repeat to total of 12-16mg Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 12mg 10mg 8mg 4mg 2mg 2mg 36 Wait at least 3 days for naloxone challenge Non-opioid meds for symptom relief CTN 002
37 Role of Oral Naltrexone for Induction Opioid use disorder When unable to proceed to XR-NTX same day Give 25mg-50mg po and have patient return next day Alcohol use disorder As bridging measure until XR-NTX induction 12mg-50mg QD Waiting hrs after last dose of oral NTX to begin XR-NTX decreases nausea 37
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