Alcoholism Clinical Trial
Official title:
Naltrexone and CBT for Problem-drinking MSM
Verified date | April 2013 |
Source | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | June 2010 |
Est. primary completion date | February 2010 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Research Foundation for Mental Hygiene, Columbia Addiction Services and Psychotherapy Intervention Research, 3 Columbus Circle, Suite 1404 | New York | New York |
Lead Sponsor | Collaborator |
---|---|
National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quantity of alcohol use | 9 months | ||
Primary | Frequency of binge drinking | 9 months | ||
Secondary | Frequency of HIV risk behavior | 9 months |
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