Status:
COMPLETED
Medication and Counseling for Controlled Drinking (Project SMART)
Lead Sponsor:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcohol-related Disorders
Alcohol Drinking
Eligibility:
MALE
18-65 years
Phase:
PHASE3
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00444418
Start Date
April 1 2006
End Date
June 1 2010
Last Update
May 1 2013
Active Locations (1)
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1
Research Foundation for Mental Hygiene, Columbia Addiction Services and Psychotherapy Intervention Research, 3 Columbus Circle, Suite 1404
New York, New York, United States, 10019