Medication and Counseling for Controlled Drinking (Project SMART)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alexis Kuerbis, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier:
NCT00444418
First received: March 6, 2007
Last updated: April 30, 2013
Last verified: April 2013

March 6, 2007
April 30, 2013
April 2006
February 2010   (final data collection date for primary outcome measure)
  • 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 ]
  • Quantity of alcohol use
  • Frequency of binge drinking
Complete list of historical versions of study NCT00444418 on ClinicalTrials.gov Archive Site
Frequency of HIV risk behavior [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Frequency of HIV risk behavior
Not Provided
Not Provided
 
Medication and Counseling for Controlled Drinking (Project SMART)
Naltrexone and CBT for Problem-drinking MSM

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Alcohol-related Disorders
  • Alcohol Drinking
  • Alcoholism
  • Alcohol Abuse
  • Drug: Naltrexone
    Naltrexone, 100 mg. oral dosage, daily for 12 weeks.
    Other Name: Naloxone, Revia, Depade
  • Behavioral: Modified Behavioral Self-Control Psychotherapy
    Moderation- and cognitive-behaviorally-based psychotherapy. Treatment goal of moderation of alcohol consumption. 12 weekly, 1-hour sessions.
  • Behavioral: Brief Behavioral Compliance Enhancement Therapy
    Brief supportive counseling to enhance compliance with medication and encourage goal-setting concerning alcohol consumption
  • Experimental: 1
    Active medication (Naltrexone) combined with Modified Behavioral Self-Control Psychotherapy
    Interventions:
    • Drug: Naltrexone
    • Behavioral: Modified Behavioral Self-Control Psychotherapy
    • Behavioral: Brief Behavioral Compliance Enhancement Therapy
  • Experimental: 2
    Placebo combined with Modified Behavioral Self-Control Psychotherapy
    Interventions:
    • Behavioral: Modified Behavioral Self-Control Psychotherapy
    • Behavioral: Brief Behavioral Compliance Enhancement Therapy
  • Experimental: 3
    Active medication (Naltrexone) combined with Brief Behavioral Compliance Enhancement Therapy
    Interventions:
    • Drug: Naltrexone
    • Behavioral: Brief Behavioral Compliance Enhancement Therapy
  • Placebo Comparator: 4
    Placebo + Brief Behavioral Compliance Enhancement Therapy
    Intervention: Behavioral: Brief Behavioral Compliance Enhancement Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
June 2010
February 2010   (final data collection date for primary outcome measure)

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
Male
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00444418
NIAAAMOR_015553-01A1S1, NIH Grant AA015553-01A1S1
Yes
Alexis Kuerbis, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Not Provided
Principal Investigator: Jon Morgenstern, PhD Columbia University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP