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Medication and Counseling for Controlled Drinking (Project SMART)

NCT00444418 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2013-05-01

No results posted yet for this study

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.

Conditions

  • Alcohol-related Disorders
  • Alcohol Drinking
  • Alcoholism
  • Alcohol Abuse

Interventions

DRUG

Naltrexone

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

BEHAVIORAL

Modified Behavioral Self-Control Psychotherapy

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

BEHAVIORAL

Brief Behavioral Compliance Enhancement Therapy

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

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    lead NIH

Principal Investigators

  • Jon Morgenstern, PhD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2010-02-28
Completion
2010-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00444418 on ClinicalTrials.gov