Medication and Counseling for Controlled Drinking (ProjectSMART)

Research Foundation for Mental Hygiene (RFMH)

Status and phase: Unknown; Phase 3

Conditions: Alcohol Abuse; Alcohol Dependence

Treatments: Drug: Naltrexone; Behavioral: Modified Behavioral Self-Control Psychotherapy; Behavioral: Brief Behavioral Compliance Enhancement Therapy; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01115894

AA015553-01A1S1

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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200 participants in 4 patient groups

active medication + psychotherapy

Experimental group

Treatment:

Behavioral: Modified Behavioral Self-Control Psychotherapy

Drug: Naltrexone

placebo + psychotherapy

Experimental group

Treatment:

Behavioral: Modified Behavioral Self-Control Psychotherapy

Drug: Placebo

active medication+brief supportive counseling

Experimental group

Treatment:

Behavioral: Brief Behavioral Compliance Enhancement Therapy

Drug: Naltrexone

placebo + brief supportive counseling

Experimental group

Treatment:

Behavioral: Brief Behavioral Compliance Enhancement Therapy

Drug: Placebo