Medication and Counseling for Controlled Drinking (ProjectSMART)

Naltrexone and CBT for Problem-Drinking MSM

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 evaluation 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 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.

Study Overview

• Status: Unknown
• Conditions: Alcohol Dependence; Alcohol Abuse
• Intervention / Treatment: Drug: Placebo; Behavioral: Modified Behavioral Self-Control Psychotherapy; Drug: Naltrexone; Behavioral: Brief Behavioral Compliance Enhancement Therapy

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10019
      • Columbia Addiction Services and Psychotherapy Intervention Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• 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)
• Recent (past three month) 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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: active medication + psychotherapy	Behavioral: Modified Behavioral Self-Control Psychotherapy; Moderation- and cognitive-behaviorally-based psychotherapy. Treatment goal of moderation of alcohol consumption. 12 weekly, 1-hour sessions.; Drug: Naltrexone; 100 mg oral dosage daily for 12 weeks
Experimental: placebo + psychotherapy	Drug: Placebo; Placebo; Behavioral: Modified Behavioral Self-Control Psychotherapy; Moderation- and cognitive-behaviorally-based psychotherapy. Treatment goal of moderation of alcohol consumption. 12 weekly, 1-hour sessions.
Experimental: active medication+brief supportive counseling	Drug: Naltrexone; 100 mg oral dosage daily for 12 weeks; Behavioral: Brief Behavioral Compliance Enhancement Therapy; Brief supportive counseling to enhance compliance with medication and encourage goal-setting concerning alcohol consumption.
Experimental: placebo + brief supportive counseling	Drug: Placebo; Placebo; Behavioral: Brief Behavioral Compliance Enhancement Therapy; Brief supportive counseling to enhance compliance with medication and encourage goal-setting concerning alcohol consumption.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Frequency of HIV risk behavior	9 months

Collaborators and Investigators

• Sponsor: Research Foundation for Mental Hygiene, Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: April 30, 2010
• First Submitted That Met QC Criteria: May 3, 2010
• First Posted (Estimate): May 4, 2010

Study Record Updates

• Last Update Posted (Estimate): December 10, 2012
• Last Update Submitted That Met QC Criteria: December 6, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: alcohol; problem drinking
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Narcotic Antagonists; Alcohol Deterrents; Naltrexone
• Other Study ID Numbers: AA015553-01A1S1