Medication and Counseling for Controlled Drinking (Project SMART)

Study Overview
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Brief Summary
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The purpose of this study is to study the effectiveness of medication and specialized psychotherapy in helping gay and bisexual men who do not want to quit drinking learn how to reduce their drinking to healthier levels. More information on the study is available at www.projectsmartnyc.org.

Detailed Description
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Problem drinking gay and bisexual men who try to quit drinking are at risk for relapse to heavy or problematic drinking because their social lives and social outlets are often strongly associated with alcohol. These men are most receptive to interventions focused on moderation of drinking rather than abstinence. However moderation-oriented cognitive-behavior therapy (CBT) and naltrexone (NTX) are both well established treatments for problem drinkers who wish to moderate, rather than stop, drinking. Research suggests that combining these treatments may enhance their efficacy. This study combines moderation-oriented CBT with NTX in the treatment of problem drinking gay and bisexual men, who do not wish to abstain from alcohol, to evaluate their efficacy alone and in combination. We also propose to utilize new data collection technology, Interactive Voice Response, to collect data on daily relations among drinking, sexual behavior and psychological variables thought to mediate treatment response. Our objectives are to evaluate the efficacy of 12 weeks of randomly assigned treatment, with 100 mg of NTX or placebo, combined with brief supportive therapy or modified, behavioral self-control therapy specifically tailored to gay/bisexual men; to evaluate conditional relationships between heavy drinking and likelihood of HIV risk behavior; and to evaluate daily associations among mood, craving, self-efficacy, motivation, and drinking. Assessments will include baseline, 3, 6, & 9 month follow-up. A substudy of the treatment trial will be conducted to collect and bank samples from blood for research aimed at associating naturally occurring differences in DNA with patient response to NTX, and with potential mediational mechanisms of action of NTX. Information gathered on genes or gene products may be used in conjunction with data on clinical and psychological factors obtained as part of the clinical trial to evaluate relationships among genetic variants, drug effects, and mechanisms of treatment response. Patients will be asked to give a blood sample at Week 0 of the clinical trial for the purpose of carrying out genetic research.

Official Title
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Naltrexone and CBT for Problem-drinking MSM

Conditions
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Alcohol-related Disorders, Alcohol Drinking, Alcoholism, Alcohol Abuse

Intervention / Treatment
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* Drug: Naltrexone
* Behavioral: Modified Behavioral Self-Control Psychotherapy
* Behavioral: Brief Behavioral Compliance Enhancement Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males 18-65 years old Currently sexually active with other men Report drinking at levels substantially in excess of established guidelines for non-hazardous drinking Willing to reduce drinking to non-hazardous levels English literate (8th grade level) Exclusion Criteria: Current physical disease or condition making participant inappropriate for a medication trial, including total bilirubin elevation >110%, AST or ALT elevations >300%. History of serious psychiatric illness (psychotic disorder, bipolar disorder, or psychiatric illness requiring hospitalization), current psychiatric illness (such as major depression or post-traumatic stress disorder) that requires treatment but that is currently untreated, or serious risk of suicidal or violent behavior Recent (past three months) initiation of psychotropic medication or psychotherapy, or recent change in psychotropic medication treatment Current DSM-IV diagnosis of drug (other than nicotine) dependence, or lifetime diagnosis of opioid dependence DSM-IV alcohol dependence diagnosis judged clinically severe, history or present evidence of significant alcohol withdrawal symptoms, or recurrent use of alcohol to alleviate withdrawal Regular use of opioids in the past month History of hypersensitivity to NTX Considered by study physician not to be suitable for receipt of an investigational drug Likely to require treatment with opiate pain medication during the course of the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Active medication (Naltrexone) combined with Modified Behavioral Self-Control Psychotherapy | Drug: Naltrexone<br>* Naltrexone, 100 mg. oral dosage, daily for 12 weeks.<br>* Other names: Naloxone, Revia, Depade;Behavioral: Modified Behavioral Self-Control Psychotherapy<br>* Moderation- and cognitive-behaviorally-based psychotherapy. Treatment goal of moderation of alcohol consumption. 12 weekly, 1-hour sessions.<br>Behavioral: Brief Behavioral Compliance Enhancement Therapy<br>* Brief supportive counseling to enhance compliance with medication and encourage goal-setting concerning alcohol consumption<br>|
| Experimental: 2<br>Placebo combined with Modified Behavioral Self-Control Psychotherapy | Behavioral: Modified Behavioral Self-Control Psychotherapy<br>* Moderation- and cognitive-behaviorally-based psychotherapy. Treatment goal of moderation of alcohol consumption. 12 weekly, 1-hour sessions.<br>Behavioral: Brief Behavioral Compliance Enhancement Therapy<br>* Brief supportive counseling to enhance compliance with medication and encourage goal-setting concerning alcohol consumption<br>|
| Experimental: 3<br>Active medication (Naltrexone) combined with Brief Behavioral Compliance Enhancement Therapy | Drug: Naltrexone<br>* Naltrexone, 100 mg. oral dosage, daily for 12 weeks.<br>* Other names: Naloxone, Revia, Depade;Behavioral: Brief Behavioral Compliance Enhancement Therapy<br>* Brief supportive counseling to enhance compliance with medication and encourage goal-setting concerning alcohol consumption<br>|
| Placebo Comparator: 4<br>Placebo + Brief Behavioral Compliance Enhancement Therapy | Behavioral: Brief Behavioral Compliance Enhancement Therapy<br>* Brief supportive counseling to enhance compliance with medication and encourage goal-setting concerning alcohol consumption<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantity of alcohol use |  | 9 months | 
| Frequency of binge drinking |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of HIV risk behavior |  | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drinking, Alcohol problems, Alcoholism, Gay men, Bisexual men, Moderation-oriented treatment, Controlled drinking, Non-abstinence based treatment