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
  Purpose

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.


Condition Intervention Phase
Alcohol-related Disorders
Alcohol Drinking
Alcoholism
Alcohol Abuse
Drug: Naltrexone
Behavioral: Modified Behavioral Self-Control Psychotherapy
Behavioral: Brief Behavioral Compliance Enhancement Therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, 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 National Institute on Alcohol Abuse and Alcoholism (NIAAA):

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: April 2006
Study Completion Date: June 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Active medication (Naltrexone) combined with Modified Behavioral Self-Control Psychotherapy
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: 2
Placebo combined with Modified Behavioral Self-Control 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.
Behavioral: Brief Behavioral Compliance Enhancement Therapy
Brief supportive counseling to enhance compliance with medication and encourage goal-setting concerning alcohol consumption
Experimental: 3
Active medication (Naltrexone) combined with Brief Behavioral Compliance Enhancement Therapy
Drug: Naltrexone
Naltrexone, 100 mg. oral dosage, daily for 12 weeks.
Other Name: Naloxone, Revia, Depade
Behavioral: Brief Behavioral Compliance Enhancement Therapy
Brief supportive counseling to enhance compliance with medication and encourage goal-setting concerning alcohol consumption
Placebo Comparator: 4
Placebo + Brief Behavioral Compliance Enhancement Therapy
Behavioral: Brief Behavioral Compliance Enhancement Therapy
Brief supportive counseling to enhance compliance with medication and encourage goal-setting concerning alcohol consumption

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.

  Eligibility

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

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
  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: NCT00444418

Locations
United States, New York
Research Foundation for Mental Hygiene, Columbia Addiction Services and Psychotherapy Intervention Research, 3 Columbus Circle, Suite 1404
New York, New York, United States, 10019
Sponsors and Collaborators
Investigators
Principal Investigator: Jon Morgenstern, PhD Columbia University
  More Information

No publications provided

Responsible Party: Alexis Kuerbis, Co-Investigator, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier: NCT00444418     History of Changes
Other Study ID Numbers: NIAAAMOR_015553-01A1S1, NIH Grant AA015553-01A1S1
Study First Received: March 6, 2007
Last Updated: April 30, 2013
Health Authority: United States: Federal Government

Keywords provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):
Drinking
Alcohol problems
Alcoholism
Gay men
Bisexual men
Moderation-oriented treatment
Controlled drinking
Non-abstinence based treatment

Additional relevant MeSH terms:
Alcohol Drinking
Alcoholism
Alcohol-Related Disorders
Drinking Behavior
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 27, 2014