Medication and Counseling for Controlled Drinking (Project SMART)
Condition: Alcohol-related Disorders; Alcohol Drinking; Alcoholism; Alcohol Abuse
MeSH terms: Alcoholism; Alcohol-Related Disorders; Alcohol Drinking
Study type: Interventional
Phase: Phase 3

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.
    

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 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 evaluate
      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 and 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.
    

Intervention name(s): Naltrexone; Modified Behavioral Self-Control Psychotherapy; Brief Behavioral Compliance Enhancement Therapy
Intervention type(s): Drug; Behavioral; Behavioral
Intervention description(s): Naltrexone, 100 mg. oral dosage, daily for 12 weeks.; Moderation- and cognitive-behaviorally-based psychotherapy. Treatment goal of moderation of alcohol consumption. 12 weekly, 1-hour sessions.; Brief supportive counseling to enhance compliance with medication and encourage goal-setting concerning alcohol consumption
Other intervention name(s): Naloxone, Revia, Depade
Intervention MeSH terms: Naltrexone; Naloxone
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drinking; Alcohol problems; Alcoholism; Gay men; Bisexual men; Moderation-oriented treatment; Controlled drinking; Non-abstinence based treatment