Medication and Counseling for Controlled Drinking (Project SMART)

NCT ID: NCT00444418

Last Updated: 2013-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2010-06-30

Brief Summary

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

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.

Conditions

Alcohol-related Disorders; Alcohol Drinking; Alcoholism; Alcohol Abuse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Active medication (Naltrexone) combined with Modified Behavioral Self-Control Psychotherapy

Group Type: EXPERIMENTAL

Naltrexone

Intervention Type: DRUG

Naltrexone, 100 mg. oral dosage, daily for 12 weeks.

Modified Behavioral Self-Control Psychotherapy

Intervention Type: BEHAVIORAL

Moderation- and cognitive-behaviorally-based psychotherapy. Treatment goal of moderation of alcohol consumption. 12 weekly, 1-hour sessions.

Brief Behavioral Compliance Enhancement Therapy

Intervention Type: BEHAVIORAL

Brief supportive counseling to enhance compliance with medication and encourage goal-setting concerning alcohol consumption

2

Placebo combined with Modified Behavioral Self-Control Psychotherapy

Group Type: EXPERIMENTAL

Modified Behavioral Self-Control Psychotherapy

Intervention Type: BEHAVIORAL

Moderation- and cognitive-behaviorally-based psychotherapy. Treatment goal of moderation of alcohol consumption. 12 weekly, 1-hour sessions.

Brief Behavioral Compliance Enhancement Therapy

Intervention Type: BEHAVIORAL

Brief supportive counseling to enhance compliance with medication and encourage goal-setting concerning alcohol consumption

3

Active medication (Naltrexone) combined with Brief Behavioral Compliance Enhancement Therapy

Group Type: EXPERIMENTAL

Naltrexone

Intervention Type: DRUG

Naltrexone, 100 mg. oral dosage, daily for 12 weeks.

Brief Behavioral Compliance Enhancement Therapy

Intervention Type: BEHAVIORAL

Brief supportive counseling to enhance compliance with medication and encourage goal-setting concerning alcohol consumption

4

Placebo + Brief Behavioral Compliance Enhancement Therapy

Group Type: PLACEBO_COMPARATOR

Brief Behavioral Compliance Enhancement Therapy

Intervention Type: BEHAVIORAL

Brief supportive counseling to enhance compliance with medication and encourage goal-setting concerning alcohol consumption

Interventions

Naltrexone

Naltrexone, 100 mg. oral dosage, daily for 12 weeks.

Intervention Type: DRUG

Modified Behavioral Self-Control Psychotherapy

Moderation- and cognitive-behaviorally-based psychotherapy. Treatment goal of moderation of alcohol consumption. 12 weekly, 1-hour sessions.

Intervention Type: BEHAVIORAL

Brief Behavioral Compliance Enhancement Therapy

Brief supportive counseling to enhance compliance with medication and encourage goal-setting concerning alcohol consumption

Intervention Type: BEHAVIORAL

Other Intervention Names

Naloxone, Revia, Depade

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: lead

Responsible Party

Alexis Kuerbis

Co-Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jon Morgenstern, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Research Foundation for Mental Hygiene, Columbia Addiction Services and Psychotherapy Intervention Research, 3 Columbus Circle, Suite 1404

New York, New York, United States

Countries

United States

Other Identifiers

NIH Grant AA015553-01A1S1

Identifier Type: -

Identifier Source: secondary_id

NIAAAMOR_015553-01A1S1

Identifier Type: -

Identifier Source: org_study_id