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Sponsored by: |
National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
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Information provided by: | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
ClinicalTrials.gov Identifier: | NCT00444418 |
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 |
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Alcohol-Related Disorders Alcohol Drinking Alcoholism Alcohol Abuse |
Drug: Naltrexone Behavioral: Modified Behavioral Self-Control Psychotherapy Behavioral: Brief Behavioral Compliance Enhancement Therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Factorial Assignment, Efficacy Study |
Official Title: | Naltrexone and CBT for Problem-Drinking MSM |
Estimated Enrollment: | 240 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
active medication + psychotherapy
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Drug: Naltrexone
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.
Behavioral: Brief Behavioral Compliance Enhancement Therapy
Brief supportive counseling to enhance compliance with medication and encourage goal-setting concerning alcohol consumption
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2: Experimental
placebo + psychotherapy
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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
|
3: Experimental
active medication + brief supportive counseling
|
Drug: Naltrexone
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
|
4: Placebo Comparator
placebo + brief supportive counseling
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Behavioral: Brief Behavioral Compliance Enhancement Therapy
Brief supportive counseling to enhance compliance with medication and encourage goal-setting concerning alcohol consumption
|
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Svetlana Zilberman, BA | 212-974-0597 | info@projectsmartnyc.org |
Contact: Alexis Kuerbis, MSW | 212-974-0535 | Kuerbis@pi.cpmc.columbia.edu |
United States, New York | |
Research Foundation for Mental Hygiene, Columbia Addiction Services and Psychotherapy Intervention Research, 1775 Broadway, Suite 1404 | Recruiting |
New York, New York, United States, 10019 | |
Sub-Investigator: Alexis N. Kuerbis, MSW |
Principal Investigator: | Jon Morgenstern, PhD | Columbia University |
Responsible Party: | Research Foundation for Mental Hygiene, Inc. ( Jon Morgenstern, Ph.D. ) |
Study ID Numbers: | NIAAAMOR_015553-01A1S1, NIH Grant AA015553-01A1S1 |
Study First Received: | March 6, 2007 |
Last Updated: | October 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00444418 History of Changes |
Health Authority: | United States: Federal Government |
Drinking Alcohol problems Alcoholism Gay men |
Bisexual men Moderation-oriented treatment Controlled drinking Non-abstinence based treatment |
Mental Disorders Narcotic Antagonists Naltrexone Alcoholism Substance-Related Disorders Drinking Behavior |
Disorders of Environmental Origin Narcotics Alcohol-Related Disorders Peripheral Nervous System Agents Alcohol Drinking Ethanol |
Narcotic Antagonists Physiological Effects of Drugs Drinking Behavior Disorders of Environmental Origin Alcohol Drinking Pharmacologic Actions Mental Disorders Sensory System Agents |
Therapeutic Uses Alcoholism Naltrexone Substance-Related Disorders Alcohol-Related Disorders Peripheral Nervous System Agents Central Nervous System Agents |