Medication and Counseling for Controlled Drinking (Project SMART)

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Naloxone; Naltrexone

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