Medication and Counseling for Controlled Drinking (ProjectSMART)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jon Morgenstern, Ph.D., Research Foundation for Mental Hygiene
ClinicalTrials.gov Identifier:
NCT01115894
First received: April 30, 2010
Last updated: December 6, 2012
Last verified: December 2012
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Naltrexone and CBT for Problem-Drinking MSM

Resource links provided by NLM:


Further study details as provided by Research Foundation for Mental Hygiene, Inc.:

Primary Outcome Measures:
  • Quantity of alcohol use [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Frequency of binge drinking [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency of HIV risk behavior [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: February 2007
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: active medication + psychotherapy Drug: Naltrexone
100 mg oral dosage daily for 12 weeks
Behavioral: 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
Placebo
Experimental: active medication+brief supportive counseling Drug: Naltrexone
100 mg oral dosage daily for 12 weeks
Behavioral: 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
Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)
  • Recent (past three month) 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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01115894

Locations
United States, New York
Columbia Addiction Services and Psychotherapy Intervention Research
New York, New York, United States, 10019
Sponsors and Collaborators
Research Foundation for Mental Hygiene, Inc.
  More Information

No publications provided

Responsible Party: Jon Morgenstern, Ph.D., Principle Investigator, Research Foundation for Mental Hygiene
ClinicalTrials.gov Identifier: NCT01115894     History of Changes
Other Study ID Numbers: AA015553-01A1S1
Study First Received: April 30, 2010
Last Updated: December 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Research Foundation for Mental Hygiene, Inc.:
problem drinking
alcohol

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 20, 2014