Clinical trial NCT00444418: Medication and Counseling for Controlled Drinking (Project SMART)
Official title: Naltrexone and CBT for Problem-drinking MSM
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alcohol-related Disorders
Alcohol Drinking
Alcoholism
Alcohol Abuse
Keywords: Drinking
Alcohol problems
Alcoholism
Gay men
Bisexual men
Moderation-oriented treatment
Controlled drinking
Non-abstinence based treatment
Lead sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Sponsor class: NIH
First posted: 2007-03-07
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Quantity of alcohol use
timeFrame: 9 months
measure: Frequency of binge drinking
timeFrame: 9 months
Secondary outcomes:
measure: Frequency of HIV risk behavior
timeFrame: 9 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Research Foundation for Mental Hygiene, Columbia Addiction Services and Psychotherapy Intervention Research, 3 Columbus Circle, Suite 1404
state: New York
Study officials:
affiliation: Columbia University
name: Jon Morgenstern, PhD
role: PRINCIPAL_INVESTIGATOR
References: