Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction. A Treatment Improvement Protocol TIP

Transcription

1 Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction A Treatment Improvement Protocol TIP 0 U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Center for Substance Abuse Treatment BP Buprenorphine Clinical Guide

2 Appendix F Federation of State Medical Boards Model Policy Guidelines for Opioid Addiction Treatment in the Medical Office SECTION I: PREAMBLE The (name of board) recognizes that the prevalence of addiction to heroin and other opioids has risen sharply in the United States and that the residents of the State of (name of state) should have access to modern, appropriate and effective addiction treatment. The appropriate application of up-to-date knowledge and treatment modalities can successfully treat patients who suffer from opioid addiction and reduce the morbidity, mortality and costs associated with opioid addiction, as well as public health problems such as HIV, HBV, HCV and other infectious diseases. The Board encourages all physicians to assess their patients for a history of substance abuse and potential opioid addiction. The Board has developed these guidelines in an effort to balance the need to expand treatment capacity for opioid addicted patients with the need to prevent the inappropriate, unwise or illegal prescribing of opioids. Until recently, physicians have been prohibited from prescribing and dispensing opioid medications in the treatment of opioid addiction, except within the confines of federally regulated opioid treatment programs. Because of the increasing number of opioid-addicted individuals and the associated public health problems, as well as the limited availability of addiction treatment programs, federal laws now enable qualified physicians to prescribe Schedule III-V medications approved by the Food and Drug Administration for office-based treatment of opioid addiction[]. Physicians who consider office-based treatment of opioid addiction must be able to recognize the condition of drug or opioid addiction and

3 be knowledgeable about the appropriate use of opioid agonist, antagonist, and partial agonist medications. Physicians must also demonstrate required qualifications as defined under and in accordance with the Drug Addiction Treatment Act of 000 (DATA) (Public Law 06-0, Title XXXV, Sections 0 and 0) and obtain a waiver from the Substance Abuse and Mental Health Services Administration (SAMHSA), as authorized by the Secretary of HHS. In order to qualify for a waiver, physicians must hold a current license in the State of (name of state) and, at a minimum, meet one or more of the following conditions to be considered as qualified to treat opioid addicted patients in an office-based setting in this state: Subspecialty board certification in addiction psychiatry from the American Board of Medical Specialties Subspecialty board certification in addiction medicine from the American Osteopathic Association Addiction certification from the American Society of Addiction Medicine Completion of not less than 8 hours of training related to the treatment and management of opioid-dependent patients provided by the American Society of Addiction Medicine, the American Academy of Addiction Psychiatry, the American Medical Association, the American Osteopathic Association, the American Psychiatric Association, or other organization approved by the board. Participation as an investigator in one or more clinical trials leading to the approval of a narcotic drug in Schedule III, IV, or V or a combination of such drugs for treatment of opioid addicted patients (must be evidenced by a statement submitted to the Secretary of Health and Human Services by the sponsor of such approved drug). Additional qualification criteria may be added through legislative enactment. In addition to the waiver, physicians must have a valid DEA registration number and a DEA identification number that specifically authorizes such office-based treatment. The waiver to provide addiction treatment under DATA is granted by the Secretary of HHS, presumably through SAMHSA, no later than days after receipt of the physician s written notification. Upon request from SAMHSA, the Attorney General, presumably through DEA, will automatically assign the physician an identification number that will be used with the physician s DEA registration number. However, if SAMHSA has not acted on the physician s request for a waiver by the end of this -day period, DEA will automatically assign the physician an identification number. Furthermore, if a physician wishes to prescribe or dispense narcotic drugs for maintenance or detoxification treatment on an emergency basis in order to facilitate the treatment of an individual patient before the -day waiting period has elapsed, the physician musty notify SAMHSA and the DEA of the physician s intent to provide such treatment. The Board recognizes that new treatment modalities offer an alternative in the treatment of opioid addiction. Based on appropriate patient assessment and evaluation, it may be both feasible and desirable to provide office-based treatment of opioid addicted patients with Schedules III-V opioid medications approved for such use by the FDA and regulated in such use by Center for Substance Abuse Treatment (CSAT)/SAMHSA. Physicians are referred to the Buprenorphine Clinical Practice Guidelines, available at the CSAT/SAMHSA, Division of Pharmacologic Therapies, Second Floor, Choke Cherry Road, Rockville, MD 087; (0) -76 or The medical recognition and management of opioid addiction should be based upon current knowledge and research and includes the use of both pharmaceutical and nonpharmaceutical modalities. Prior to initiating FSMB Model Policy Guidelines for Opioid Addiction Treatment

4 treatment, physicians should be knowledgeable about addiction treatment and all available pharmacologic treatment agents as well as available ancillary services to support both the physician and patient. In order to undertake treatment of opioid addicted patients, in accordance with these guidelines, physicians must demonstrate a capacity to refer patients for appropriate counseling and other ancillary services. The (state medical board) is obligated under the laws of the State of (name of state) to protect the public health and safety. The Board recognizes that inappropriate prescribing of controlled substances, including opioids, may lead to drug diversion and abuse by individuals who seek them for other than legitimate medical use. Physicians must be diligent in preventing the diversion of drugs for illegitimate and nonmedical uses. Qualified physicians need not fear disciplinary action from the Board or other state regulatory or enforcement agency for appropriate prescribing, dispensing or administering approved opioid drugs in Schedules III, IV, or V, or combinations thereof, for a legitimate medical purpose in the usual course of opioid addiction treatment. The Board will consider appropriate prescribing, ordering, administering, or dispensing of these medications for opioid addiction to be for a legitimate medical purpose if based on accepted scientific knowledge of the treatment of opioid addiction and in compliance with applicable state and federal law. The Board will determine the appropriateness of prescribing based on the physician s overall treatment of the patient and on available documentation of treatment plans and outcomes. The goal is to document and treat the patient s addiction while effectively addressing other aspects of the patient s functioning, including physical, psychological, medical, social and work-related factors. The following guidelines are not intended to define complete or best practice, but rather to communicate what the Board considers to be within the boundaries of accepted professional practice. SECTION II: GUIDELINES The Board has adopted the following guidelines when evaluating the documentation and treatment of opioid addiction under DATA: Compliance With Controlled Substances Laws and Regulations Generally, to prescribe and dispense Schedules III-V opioid medications for the treatment of opioid addiction under DATA, the physician must be licensed in the state, have a valid DEA controlled substances registration and identification number, comply with federal and state regulations applicable to controlled substances, and have a current waiver issued by SAMHSA. To obtain this waiver, the physician must submit written notification to the Secretary of HHS of their intent to provide this treatment modality, certifying the physician s qualifications and listing his/her DEA registration number. SAMHSA will then notify DEA whether a waiver has been granted. If SAMHSA grants the physician a waiver, DEA will issue the qualifying physician an identification number. In addition to these requirements, the DATA limits the number of patients that a physician or a group practice is permitted to treat to 0. This numerical limitation may be changed by regulation in the future. Physicians are specifically prohibited from delegating prescribing opioids for detoxification and/or maintenance treatment purposes to non-physicians. Physicians are referred to DEA regulations (CFR, Part 00 to end) and the DEA Physician s Manual and (any relevant documents issued by the state medical board) for specific rules governing issuance of controlled substances prescriptions as well as applicable state regulations. Evaluation of the Patient A recent, complete medical history and physical examination must be documented in FSMB Model Policy Guidelines for Opioid Addiction Treatment

5 the medical record. The medical record should document the nature of the patient s addiction(s), evaluate underlying or coexisting diseases or conditions, the effect on physical and psychological function, and history of substance abuse and any treatments therefor. The medical record should also document the suitability of the patient for office-based treatment based upon recognized diagnostic criteria.[] DSM-IV-TR Substance Dependence Criteria [] A maladaptive pattern of substance use, leading to clinically significant impairment or distress, as manifested by three (or more) of the following, occurring at any time in the same -month period: tolerance, as defined by either of the following: a need for markedly increased amounts of the substance to achieve intoxication or desired effect, or markedly diminished effect with continued use of the same amount of the substance withdrawal, as manifested by either of the following: the characteristic withdrawal syndrome for the substance, or the same (or closely related) substance is taken to relieve or avoid withdrawal symptoms the substance is often taken in larger amounts or over longer period than was intended there is a persistent desire or unsuccessful efforts to cut down or control substance use a great deal of time is spent in activities necessary to obtain the substance (e.g., visiting multiple doctors or driving long distances), use the substance (e.g., chainsmoking), or recover from its effects important social, occupational or recreational activities are given up or reduced because of substance use the substance use is continued despite knowledge of having a persistent or recurrent physical or psychological problem that is likely to have been caused or exacerbated by the substance (e.g., current cocaine use despite recognition of cocaineinduced depression, or continued drinking despite recognition that an ulcer was made worse by alcohol consumption) Treatment Plan The written treatment plan should state objectives that will be used to determine treatment success, such as freedom from intoxication, improved physical function, psychosocial function and compliance and should indicate if any further diagnostic evaluations are planned, as well as counseling, psychiatric management or other ancillary services. This plan should be reviewed periodically. After treatment begins, the physician should adjust drug therapy to the individual medical needs of each patient. Treatment goals, other treatment modalities or a rehabilitation program should be evaluated and discussed with the patient. If possible, every attempt should be made to involve significant others or immediate family members in the treatment process, with the patient s consent. The treatment plan should also contain contingencies for treatment failure (i.e., due to failure to comply with the treatment plan, abuse of other opioids, or evidence that the Schedules III-V medications are not being taken). Informed Consent and Agreement for Treatment The physician should discuss the risks and benefits of the use of these approved opioid medications with the patient and, with appropriate consent of the patient, significant FSMB Model Policy Guidelines for Opioid Addiction Treatment

6 other(s), family members, or guardian. The patient should receive opioids from only one physician and/or one pharmacy when possible. The physician should employ the use of a written agreement between physician and patient addressing such issues as () alternative treatment options; () regular toxicologic testing for drugs of abuse and therapeutic drug levels (if available and indicated); () number and frequency of all prescription refills and () reasons for which drug therapy may be discontinued (i.e.; violation of agreement). Periodic Patient Evaluation Patients should be seen at reasonable intervals (at least weekly during initial treatment) based upon the individual circumstance of the patient. Periodic assessment is necessary to determine compliance with the dosing regimen, effectiveness of treatment plan, and to assess how the patient is handling the prescribed medication. Once a stable dosage is achieved and urine (or other toxicologic) tests are free of illicit drugs, less frequent office visits may be initiated (monthly may be reasonable for patients on a stable dose of the prescribed medication(s) who are making progress toward treatment objectives). Continuation or modification of opioid therapy should depend on the physician s evaluation of progress toward stated treatment objectives such as () absence of toxicity () absence of medical or behavioral adverse effects () responsible handling of medications () compliance with all elements of the treatment plan (including recovery-oriented activities, psychotherapy and/or other psychosocial modalities) and () abstinence from illicit drug use. If reasonable treatment goals are not being achieved, the physician should re-evaluate the appropriateness of continued treatment. Consultation The physician should refer the patient as necessary for additional evaluation and treatment in order to achieve treatment objectives. The physician should pursue a team approach to the treatment of opioid addiction, including referral for counseling and other ancillary services. Ongoing communication between the physician and consultants is necessary to ensure appropriate compliance with the treatment plan. This may be included in the formal treatment agreement between the physician and patient. Special attention should be given to those patients who are at risk for misusing their medications and those whose living or work arrangements pose a risk for medication misuse or diversion. The management of addiction in patients with comorbid psychiatric disorders requires extra care, monitoring, documentation and consultation with or referral to a mental health professional. Medical Records The prescribing physician should keep accurate and complete records to include () the medical history and physical examination; () diagnostic, therapeutic and laboratory results; () evaluations and consultations; () treatment objectives; () discussion of risks and benefits; (6) treatments; (7) medications (including date, type, dosage, and quantity prescribed and/or dispensed to each patient); (8) a physical inventory of all Schedules III, IV, and V controlled substances on hand that are dispensed by the physician in the course of maintenance or detoxification treatment of an individual; (9) instructions and agreements; and (0) periodic reviews. Records should remain current and be maintained in an accessible manner and readily available for review. The physician must adhere to the special confidentiality requirements of CFR, Part, which apply to the treatment of drug and alcohol addiction, including the prohibition against release of records or other information, except pursuant to a proper patient consent or court order in full compliance with CFR, or the Federal or State officials listed in CFR, or in cases of true medical emergency or for the mandatory reporting of child abuse. FSMB Model Policy Guidelines for Opioid Addiction Treatment

7 SECTION III: DEFINITIONS For the purposes of these guidelines, the following terms are defined as follows: Addiction: A primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm and craving. Agonists: Agonist drugs are substances that bind to the receptor and produce a response that is similar in effect to the natural ligand that would activate it. Full mu opioid agonists activate mu receptors, and increasing doses of full agonists produce increasing effects. Most opioids that are abused, such as morphine and heroin are full mu opioid agonists. Approved Schedule III-V Opioids : Opioids referred to by the DATA, specifically approved by the FDA for treatment of opioid dependence or addiction. Antagonists: Antagonists bind to but do not activate receptors. They prevent the receptor from being activated by an agonist compound. Examples of opioid antagonists are naltrexone and naloxone. Maintenance Treatment: Maintenance treatment means the dispensing for a period in excess of days of an opioid medication(s) at stable dosage levels in the treatment of an individual for dependence upon heroin or other morphine-like drugs. Opioid Dependence: A maladaptive pattern of substance use, leading to clinically significant impairment or distress, manifested by or more of the following, occurring at any time in the same -month period: A need for markedly increased amounts of the substance to achieve intoxication or desired effect or markedly diminished effect with continued use of the same amount of substance; The characteristic withdrawal syndrome for the substance or the same (or closely related) substance is taken to relieve or avoid withdrawal symptoms; The substance was taken in larger amounts or over a longer period of time than was intended; There is a persistent desire or unsuccessful efforts to cut down or control substance use; Significant time is spent on activities to obtain the substance, use the substance, or recover from its effects; Important social, occupational, or recreational activities are discontinued or reduced because of substance use; Substance use is continued despite knowledge of having a persistent physical or psychological problem that is caused or exacerbated by the substance. Opioid Drug: Opioid drug means any drug having an addiction-forming or addictionsustaining liability similar to morphine or being capable of conversion into a drug having such addiction-forming or addiction sustaining liability. (this is referred to as an opiate in the Controlled Substances Act) Opioid Treatment Program (OTP) (sometimes referred to as a methadone clinic or narcotic treatment program): Opioid treatment program means a licensed program or practitioner engaged in the treatment of opioid addicted patients with approved Scheduled II opioids (methadone and/or LAAM). Partial Agonists: Partial agonists occupy and activate receptors. At low doses, like full agonists, increasing doses of the partial agonist produce increasing effects. However, unlike full agonists, the receptor-activation produced by a partial agonist reaches a plateau over which increasing doses do not produce an increasing effect. The plateau may have the effect of limiting the partial agonist s therapeutic activity as well as its toxicity. 6 FSMB Model Policy Guidelines for Opioid Addiction Treatment

8 Buprenorphine is an example of a partial agonist. Physical Dependence: A state of adaptation that is manifested by a drug class specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist. Qualified Physician: A physician, licensed in the State of (name of state) who holds a current waiver issued by SAMHSA (as authorized by the Secretary of HHS) and meets one or more of the conditions set forth in Section. In addition, a physician must have a valid DEA registration and identification number authorizing the physician to conduct office-based treatment. Substance Abuse: A maladaptive pattern of substance use leading to clinically significant impairment or distress, as manifested by one or more of the following, occurring within a -month period: Recurrent substance use resulting in a failure to fulfill major role obligations at work, school, or home; Recurrent substance use in situations in which it is physically hazardous; Recurrent substance-related legal problems; Continued substance use despite having persistent or recurrent social or interpersonal problems caused or exacerbated by the effects of the substance. Tolerance: A state of adaptation in which exposure to a drug induces changes that result in diminution of one or more of the drug s effects over time. Waiver: A documented authorization from the Secretary of HHS issued by SAMHSA under the DATA that exempts qualified physicians from the rules applied to OTPs. Implementation of the waiver includes possession of a valid DEA certificate with applicable suffix. Footnotes: [] Drug Addiction Treatment Act of 000, Public Law 06-0, Title XXXV, Section 0 and 0. [] Buprenorphine Clinical Practice Guidelines, Table -. [] American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders, th ed., Text Revision, Washington, D.C. This document can be found on model policy guidelines at then click on policy documents. The recommendations contained herein were adopted as policy by the House of Delegates of the Federation of State Medical Boards of the United States, Inc., April 00. FSMB Model Policy Guidelines for Opioid Addiction Treatment 7

9 Appendix G Stages of Change As an important component of effective treatment planning, physicians may find it helpful to determine which stage of change characterizes the patient. There are six stages of change: precontemplation, contemplation, preparation, action, maintenance, and relapse. Patients can be conceptualized as moving along a continuum marked by these stages, each of which is described below. Readiness to change and stage of change can be evaluated by interview and instruments such as the Stages of Change Readiness and Treatment Eagerness Scale (Miller and Tonigan 996). Stages of change are clearly linked to a patient s motivation. It may be possible for a physician to increase motivation (e.g., through motivational enhancement therapy) and thus help a patient move from an early stage of change (e.g., contemplation) to a more active and healthy stage (e.g., action). The discussion of Stages of Changes below is excerpted from Center for Substance Abuse Treatment (CSAT) TIP, Enhancing Motivation for Change in Substance Abuse Treatment (CSAT 999b). (See products/manuals/index.htm.) Transtheoretical Model of Stages of Change It is important to note that the change process is cyclical, and individuals typically move back and forth between the stages and cycle through the stages at different rates. In one individual, this movement through the stages can vary in relation to different behaviors or objectives. Individuals can move through stages quickly. Sometimes, they move so rapidly that it is difficult to pinpoint where they are because change is a dynamic process. It is not uncommon, however, for individuals to linger in the early stages. For most substance-using individuals, progress through the stages of change is circular or spiral in nature, not linear. In this model, recurrence is a normal event because many clients cycle through the 9

10 different stages several times before achieving stable change. The six stages and the issue of relapse are described below. Precontemplation During the precontemplation stage, substanceusing individuals are not considering change and do not intend to change behaviors in the foreseeable future. They may be partly or completely unaware that a problem exists, that they have to make changes, and that they may need help in this endeavor. Alternatively, they may be unwilling or too discouraged to change their behavior. Individuals in this stage usually have not experienced adverse consequences or crises because of their substance use and often are not convinced that their pattern of use is problematic or even risky. Contemplation As these individuals become aware that a problem exists, they begin to perceive that there may be cause for concern and reasons to change. Typically, they are ambivalent, simultaneously seeing reasons to change and reasons not to change. Individuals in this stage are still using substances, but they are considering the possibility of stopping or cutting back in the near future. At this point, they may seek relevant information, reevaluate their substance use behavior, or seek help to support the possibility of changing behavior. They typically weigh the positive and negative aspects of making a change. It is not uncommon for individuals to remain in this stage for extended periods, often for years, vacillating between wanting and not wanting to change. Preparation When an individual perceives that the envisioned advantages of change and adverse consequences of substance use outweigh any positive features of continuing use at the same level and maintaining the status quo, the decisional balance tips in favor of change. Once instigation to change occurs, an individual enters the preparation stage, during which commitment is strengthened. Preparation entails more specific planning for change, such as making choices about whether treatment is needed and, if so, what kind. Preparation also entails an examination of one s perceived capabilities or selfefficacy for change. Individuals in the preparation stage are still using substances, but typically they intend to stop using very soon. They may have already attempted to reduce or stop use on their own or may be experimenting now with ways to quit or cut back (DiClemente and Prochaska 998). They begin to set goals for themselves and make commitments to stop using, even telling close associates or significant others about their plans. Action Individuals in the action stage choose a strategy for change and begin to pursue it. At this stage, clients are actively modifying their habits and environment. They are making drastic lifestyle changes and may be faced with particularly challenging situations and the physiological effects of withdrawal. Clients may begin to reevaluate their own self-image as they move from excessive or hazardous use to nonuse or safe use. For many, the action stage can last from to 6 months following termination or reduction of substance use. For some, it is a honeymoon period before they face more daunting and longstanding challenges. Maintenance During the maintenance stage, efforts are made to sustain the gains achieved during the action stage. Maintenance is the stage at which individuals work to sustain sobriety and prevent recurrence (Marlatt and Gordon 98). Extra precautions may be necessary to keep from reverting to problematic behaviors. Individuals learn how to detect and guard 0 Stages of Change

11 against dangerous situations and other triggers that may cause them to use substances again. In most cases, individuals attempting long-term behavior change do return to use at least once and revert to an earlier stage (Prochaska and DiClemente 99). Recurrence of symptoms can be viewed as part of the learning process. Knowledge about the personal cues or dangerous situations that contribute to recurrence is useful information for future change attempts. Maintenance requires prolonged behavioral change by remaining abstinent or moderating consumption to acceptable, targeted levels and continued vigilance for a minimum of 6 months to several years, depending on the target behavior (Prochaska and DiClemente 99). Relapse Most individuals do not immediately sustain the new changes they are attempting to make, and a return to substance use after a period of abstinence is the rule rather than the exception (Brownell et al. 986; Prochaska and DiClemente 99). These experiences contribute information that can facilitate or hinder subsequent progression through the stages of change. Recurrence, often referred to as relapse, is the event that triggers the individual s return to earlier stages of change and recycling through the process. Individuals may learn that certain goals are unrealistic, certain strategies are ineffective, or certain environments are not conducive to successful change. Most substance users will require several revolutions through the stages of change to achieve successful recovery (DiClemente and Scott 997). After a return to substance use, clients usually revert to an earlier change stage not always to maintenance or action, but more often to some level of contemplation. They may even become precontemplators again, temporarily unwilling or unable to try to change soon. Resuming substance use and returning to a previous stage of change should not be considered a failure and need not become a disastrous or prolonged recurrence. A recurrence of symptoms does not necessarily mean that a client has abandoned a commitment to change. Stages of Change

12 Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES 8D) INSTRUCTIONS: Please read the following statements carefully. Each one describes a way that you might (or might not) feel about your drug use. For each statement, circle one number from to to indicate how much you agree or disagree with it right now. Please circle one and only one number for every statement. NO! Strongly Disagree No Disagree? Undecided or Unsure Yes Agree YES! Strongly Agree. I really want to make changes in my use of drugs.. Sometimes I wonder if I am an addict.. If I don t change my drug use soon, my problems are going to get worse.. I have already started making some changes in my use of drugs.. I was using drugs too much at one time, but I ve managed to change that. 6. Sometimes I wonder if my drug use is hurting other people. 7. I have a drug problem. 8. I m not just thinking about changing my drug use, I m already doing something about it. 9. I have already changed my drug use, and I am looking for ways to keep from slipping back to my old pattern. 0. I have serious problems with drugs.. Sometimes I wonder if I am in control of my drug use.. My drug use is causing a lot of harm.. I am actively doing things now to cut down or stop my use of drugs.. I want help to keep from going back to the drug problems that I had before.. I know that I have a drug problem. 6. There are times when I wonder if I use drugs too much. 7. I am a drug addict. 8. I am working hard to change my drug use. 9. I have made some changes in my drug use, and I want some help to keep from going back to the way I used before. Source: Miller and Tonigan 996. SOCRATES 8D and SOCRATES 8D Scoring Sheet. Center on Alcoholism, Substance Abuse, and Addictions (CASAA), Assessment Instruments. Available at Reprinted with permission. Stages of Change

13 SOCRATES Scoring Form (9-Item Version 8.0) Transfer the client s answers from questionnaire (see note below): Recognition Ambivalence Taking Steps TOTALS Re Am Ts Possible Range: Stages of Change

14 SOCRATES Profile Sheet (9-Item Version 8A) INSTRUCTIONS: From the SOCRATES Scoring Form (9-Item Version) transfer the total scale scores into the empty boxes at the bottom of the Profile Sheet. Then for each scale, CIRCLE the same value above it to determine the decile range. DECILE SCORES Recognition Ambivalence Taking Steps 90 Very High High Medium 0 0 Low Very Low RAW SCORES (from Scoring Sheet) Re= Am= Ts= These interpretive ranges are based on a sample of,76 adult men and women presenting for treatment of alcohol problems through Project MATCH. Note that individual scores are therefore being ranked as low, medium, or high relative to people already presenting for alcohol treatment. Stages of Change

15 Guidelines for Interpretation of SOCRATES-8 Scores Using the SOCRATES Profile Sheet, circle the client s raw score within each of the three scale columns. This provides information as to whether the client s scores are low, average, or high relative to individuals already seeking treatment for alcohol problems. The following are provided as general guidelines for interpretation of scores, but it is wise in an individual case also to examine individual item responses for additional information. RECOGNITION HIGH scorers directly acknowledge that they are having problems related to their drinking, tending to express a desire for change and to perceive that harm will continue if they do not change. LOW scorers deny that alcohol is causing them serious problems, reject diagnostic labels such as problem drinker and alcoholic, and do not express a desire for change. AMBIVALENCE HIGH scorers say that they sometimes wonder if they are in control of their drinking, are drinking too much, are hurting other individuals, and/or are alcoholic. Thus a high score reflects ambivalence or uncertainty. A high score here reflects some openness to reflection, as might be particularly expected in the contemplation stage of change. LOW scorers say that they do not wonder whether they drink too much, are in control, are hurting others, or are alcoholic. Note that an individual may score low on ambivalence either because they know their drinking is causing problems (high Recognition), or because they know that they do not have drinking problems (low Recognition). Thus a low Ambivalence score should be interpreted in relation to the Recognition score. TAKING STEPS HIGH scorers report that they are already doing things to make a positive change in their drinking, and may have experienced some success in this regard. Change is underway, and they may want help to persist or to prevent backsliding. A high score on this scale has been found to be predictive of successful change. LOW scorers report that they are not currently doing things to change their drinking and have not made such changes recently. Resources for More Information Recovery Attitude and Treatment Evaluator (RAATE) (Mee-Lee 988). University of Rhode Island Change Assessment (URICA) (McConnaughy et al. 98). Measures/urica.htm SOCRATES (Miller and Tonigan 996) socratesv8.pdf Readiness to Change Questionnaire (Rollnick et al. 99). rtcq.htm care_plans/change.htm Stages of Change

16 Appendix H Sample Treatment Agreement/Contract Treatment agreements/contracts are often employed in the treatment of addiction to make explicit the expectations regarding patient cooperation and involvement in the treatment process. On the following page is a sample addiction treatment agreement/contract that may be a useful tool in working with patients in an office-based setting. 7

17 As a participant in the buprenorphine protocol for treatment of opioid abuse and dependence, I freely and voluntarily agree to accept this treatment agreement/contract, as follows: I agree to keep, and be on time to, all my scheduled appointments with the doctor and his/her assistant. I agree to conduct myself in a courteous manner in the physician s office. I agree not to arrive at the office intoxicated or under the influence of drugs. If I do, the doctor will not see me, and I will not be given any medication until my next scheduled appointment. I agree not to sell, share, or give any of my medication to another individual. I understand that such mishandling of my medication is a serious violation of this agreement and would result in my treatment being terminated without recourse for appeal. I agree not to deal, steal, or conduct any other illegal or disruptive activities in the doctor s office. I agree that my medication (or prescriptions) can be given to me only at my regular office visits. Any missed office visits will result in my not being able to get medication until the next scheduled visit. I agree that the medication I receive is my responsibility and that I will keep it in a safe, secure place. I agree that lost medication will not be replaced regardless of the reasons for such loss. I agree not to obtain medications from any physicians, pharmacies, or other sources without informing my treating physician. I understand that mixing buprenorphine with other medications, especially benzodiazepines such as valium and other drugs of abuse, can be dangerous. I also understand that a number of deaths have been reported among individuals mixing buprenorphine with benzodiazepines. I agree to take my medication as the doctor has instructed and not to alter the way I take my medication without first consulting the doctor. I understand that medication alone is not sufficient treatment for my disease, and I agree to participate in the patient education and relapse prevention programs, as provided, to assist me in my treatment. Printed Name Signature Date 8 Sample Treatment Agreement/Contract

18 Appendix I Glossary C.F.R. Part 9 Code of Federal Regulations (C.F.R.) that, among other things, sets standards for narcotic treatment and use of methadone. C.F.R. Part Federal Regulation concerning confidentiality of alcohol and drug abuse patient treatment records. C.F.R. Part 8 Federal Regulation concerning dispensing of drugs through opioid treatment programs. Addiction A behavioral syndrome characterized by the repeated, compulsive seeking or use of a substance despite adverse social, psychological, and/or physical consequences. Addiction is often (but not always) accompanied by physical dependence, a withdrawal syndrome, and tolerance. Alcoholism A pattern of compulsive use of alcohol in which individuals devote substantial periods of time to obtaining and consuming alcoholic beverages despite adverse psychological or physical consequences, e.g., depression, blackouts, liver disease, or other consequences. (Adapted from Diagnostic and Statistical Manual of Mental Disorders, th ed., Text Revision [DSM-IV-TR].) Antagonist Substance that tends to nullify the effect of another (e.g., a drug that binds to a receptor without eliciting a response). AUDIT Alcohol Use Disorders Identification Test. A screening tool for identification of alcohol use disorders. 9

19 Biopsychosocial Combining biological, psychological, and social concerns or effects. Buprenex (Generic: buprenorphine) Injectable formulation of the Schedule III narcotic (opioid) partial agonist buprenorphine. Approved for use as an analgesic. Not approved for use in the treatment of opioid addiction. Buprenorphine An opioid partial agonist that is a synthetic derivative of thebaine. Two sublingual formulations of buprenorphine, the Schedule III pharmaceuticals Subutex (buprenorphine) and Suboxone (buprenorphine/naloxone), received Food and Drug Administration (FDA) approval in October 000 for use in the treatment of opioid addiction. Buprenex, an injectable formulation of buprenorphine, has previously been available in the United States and is approved for use as a parenteral analgesic. Buprenorphine/naloxone Drug combination; see separate definitions and brand name Suboxone. CAGE-AID CAGE Questionnaire Adapted to Include Drugs. CAGE Questionnaire A screening tool for identification of alcohol use disorders (questions use words beginning with letters C, A, G, and E consecutively). Children s Health Act of 000 (P.L. 06-0) Legislation (Public Law) that authorizes expanded research and services for a variety of childhood health problems, reauthorizes programs of the Substance Abuse and Mental Health Services Administration (SAMHSA), addresses the problem of youth substance abuse and the violence associated with it, and works to improve the health and safety of children in child care. Title XXXV of the Children s Health Act is the Drug Addiction Treatment Act of 000 (DATA 000), which authorizes qualifying physicians to treat opioid addiction in clinical settings other than the Opioid Treatment Program (OTP) setting. CINA Clinical Institute Narcotic Assessment Scale for Withdrawal. An interview and observation tool for assessing opioid withdrawal signs and symptoms. COWS Clinical Opiate Withdrawal Scale. An interview and observation tool for assessing opioid withdrawal signs and symptoms. DAST 0 Drug Abuse Screening Test. A questionnaire tool for identification of drug and alcohol use disorders. DATA 000 See Drug Addiction Treatment Act of 000. Dependence A condition manifested as a characteristic set of withdrawal signs and symptoms upon reduction, cessation, or loss of the active compound at cell receptors (a withdrawal syndrome). Drug Addiction Treatment Act of 000 Title XXXV of the Children s Health Act of 000. The Drug Addiction Treatment Act of 000 (DATA 000) establishes a waiver authority for qualifying physicians to prescribe or dispense specially approved Schedule III, IV, and V narcotic medications for the treatment of opioid addiction in clinical settings other than the Opioid Treatment Program setting. HIPAA Health Insurance Portability and Accountability Act. 0 Glossary

20 LAAM Closely related to methadone, the synthetic compound levo-alpha-acetyl-methadol or LAAM (Brand name: ORLAMM ), has an even longer duration of action (from 8 to 7 hours) than methadone, permitting a reduction in frequency of use. In 99, it was approved as a Schedule II treatment drug for narcotic addiction. Both methadone and LAAM have high abuse potential. Their acceptability as narcotic treatment drugs is predicated on their ability to substitute for heroin, the long duration of action, and their mode of oral administration. MAST Michigan Alcohol Screening Test. A questionnaire tool for identification of alcohol use disorders. MCV Mean corpuscular volume. Methadone A Schedule II synthetic opioid with pharmacologic actions similar to morphine and heroin; almost equally addictive. Approved for use in the treatment of opioid addiction in federally regulated Opioid Treatment Programs. May be administered orally, intramuscularly, and subcutaneously. Monotherapy Therapy using one drug or approach. Morphine Most active narcotic alkaloid of opium. Has powerful analgesic action; abuse leads to dependence. Mu agonist A drug that has affinity for and stimulates physiologic activity at mu opioid cell receptors. See also opioid full agonist. Mu opioid receptor A receptor on the surface of brain cells that mediates opioid analgesia, tolerance, and addiction through drug-induced activation. When an opioid agonist, or partial agonist (e.g., buprenorphine), binds to a mu opioid receptor, a series of other proteins associated with the mu receptor-signalling pathway becomes activated. Other opioid receptors are the delta and kappa receptors. Naloxone Brand name: Narcan. An opioid antagonist, similar to naltrexone, that works by blocking opioid receptors in the brain, thereby blocking the effects of opioid full agonists (e.g., heroin, morphine) and partial agonists (e.g., buprenorphine). Naltrexone Naltrexone, a narcotic antagonist, works by blocking opioid receptors in the brain and therefore blocking the effects of opioid full agonists (e.g., heroin, morphine) and partial agonists (e.g., buprenorphine). NATA Narcotic Addict Treatment Act. Needle embolization Blood clot caused by use of a needle. If dislodged, the clot may cause death. Nonopioid Drug or compound not related to natural or synthetic opium and related alkaloids. OAT Opioid Agonist Treatment. Opioids Drugs that are derived naturally from the flower of the opium poppy plant (e.g., morphine and heroin) and those that are synthetically produced in the lab (e.g., methadone and oxycodone). Used therapeutically to treat pain, but also produce a sensation of euphoria the narcotic high. Repeated misuse and abuse of opioids often leads to dependence and addiction. Glossary

21 Opioid full agonist Drugs that have affinity for and stimulate physiologic activity at opioid cell receptors (mu, kappa, and delta) that are normally stimulated by naturally occurring opioids. Repeated administration often leads to dependence and addiction. Opioid partial agonist Drugs that can both activate and block opioid receptors, depending on the clinical situation. Partial agonists have properties of both agonists and antagonists. The mu agonist properties of partial agonists reach a maximum at a certain dose and do not continue to increase with increasing doses of the partial agonist. This is termed the ceiling effect. The ceiling effect limits the abuse potential and untoward side effects of opioid partial agonists. The Schedule III medication buprenorphine is an opioid partial agonist. Parenteral Not through the gastrointestinal route; for instance, given via intramuscular or intravenous injection. Pharmacodynamics Study of the biochemical and physiological effects of drugs and the mechanisms of their actions, including correlation of these actions and effects with the drugs chemical structure. Pharmacokinetics Study of the action of drugs in the body over a period of time, including the processes of absorption, distribution, localization in tissues, biotransformation, and excretion. Pharmacotherapy Treatment of disease by using medicines. Polysubstance abuse Concurrent use or abuse of multiple substances (e.g., drinking alcohol as well as smoking tobacco, snorting cocaine, inhaling glue fumes). Psychosocial Combining psychological and social aspects. SMAST Short Michigan Alcohol Screening Test. Shortened, self-administered version of the MAST alcohol use disorder screening tool. SOWS Subjective Opioid Withdrawal Scale. Selfadministered scale for grading opioid withdrawal symptoms. Sublingual Under the tongue. Suboxone Brand name for the Schedule III sublingual formulation of buprenorphine combined with naloxone. Received FDA approval in October 000 for use in the treatment of opioid addiction. Naloxone is added to the formulation to decrease the likelihood of abuse of the combination via the parenteral route. Subutex Brand name for the Schedule III sublingual formulation of buprenorphine. Received FDA approval in October 000 for use in the treatment of opioid addiction. Talc granulomatosis Formation of granulomas (small nodules) as a chronic inflammatory response, in the lungs or other organs, in this case to talc or other fine powder. Talc granulomatosis may occur in drug users because many injected drugs have been adulterated with an inert substance (such as talcum powder) to cut or dilute the amount of drug. Glossary