Medication and Counseling for Controlled Drinking (ProjectSMART)
|ClinicalTrials.gov Identifier: NCT01115894|
Recruitment Status : Unknown
Verified December 2012 by Jon Morgenstern, Ph.D., Research Foundation for Mental Hygiene.
Recruitment status was: Active, not recruiting
First Posted : May 4, 2010
Last Update Posted : December 10, 2012
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 evaluation 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 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.
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Dependence Alcohol Abuse||Drug: Naltrexone Behavioral: Modified Behavioral Self-Control Psychotherapy Behavioral: Brief Behavioral Compliance Enhancement Therapy Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Naltrexone and CBT for Problem-Drinking MSM|
|Study Start Date :||February 2007|
|Primary Completion Date :||December 2010|
|Experimental: active medication + psychotherapy||
100 mg oral dosage daily for 12 weeksBehavioral: Modified Behavioral Self-Control Psychotherapy
Moderation- and cognitive-behaviorally-based psychotherapy. Treatment goal of moderation of alcohol consumption. 12 weekly, 1-hour sessions.
|Experimental: placebo + psychotherapy||
Behavioral: Modified Behavioral Self-Control Psychotherapy
Moderation- and cognitive-behaviorally-based psychotherapy. Treatment goal of moderation of alcohol consumption. 12 weekly, 1-hour sessions.Drug: Placebo
|Experimental: active medication+brief supportive counseling||
100 mg oral dosage daily for 12 weeksBehavioral: Brief Behavioral Compliance Enhancement Therapy
Brief supportive counseling to enhance compliance with medication and encourage goal-setting concerning alcohol consumption.
|Experimental: placebo + brief supportive counseling||
Behavioral: Brief Behavioral Compliance Enhancement Therapy
Brief supportive counseling to enhance compliance with medication and encourage goal-setting concerning alcohol consumption.Drug: Placebo
- Quantity of alcohol use [ Time Frame: 9 months ]
- Frequency of binge drinking [ Time Frame: 9 months ]
- Frequency of HIV risk behavior [ Time Frame: 9 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01115894
|United States, New York|
|Columbia Addiction Services and Psychotherapy Intervention Research|
|New York, New York, United States, 10019|