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Counseling + Naltrexone for Alcoholism (ProjectSMART Trial)

Phase 3
Waitlist Available
Research Sponsored by Research Foundation for Mental Hygiene, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Currently sexually active with other men
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights

ProjectSMART Trial Summary

This trial is testing whether a combination of moderation-oriented CBT and NTX is effective in treating problem drinking gay and bisexual men who don't want to stop drinking.

Who is the study for?
This trial is for gay and bisexual men who are English literate, currently sexually active with other men, drink more than the guidelines suggest, and want to cut back but not quit. They can't join if they have severe liver issues, serious mental health conditions requiring hospitalization, opioid use in the last month, or a history of severe alcohol withdrawal.Check my eligibility
What is being tested?
The study tests whether combining moderation-oriented cognitive-behavior therapy (CBT) tailored for gay/bisexual men with Naltrexone (NTX), a medication that helps reduce drinking urges, is effective. Participants will either receive NTX or a placebo along with therapy over 12 weeks.See study design
What are the potential side effects?
Naltrexone may cause nausea, headaches, dizziness or sleep problems. It's also possible to experience an upset stomach or feel tired. Since it affects how your body responds to alcohol consumption during treatment, participants should report any unusual symptoms.

ProjectSMART Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am sexually active with other men.

ProjectSMART Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Bulimia
Quantity of alcohol use
Secondary outcome measures
Frequency of HIV risk behavior

ProjectSMART Trial Design

4Treatment groups
Experimental Treatment
Group I: placebo + psychotherapyExperimental Treatment2 Interventions
Group II: placebo + brief supportive counselingExperimental Treatment2 Interventions
Group III: active medication+brief supportive counselingExperimental Treatment2 Interventions
Group IV: active medication + psychotherapyExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Modified Behavioral Self-Control Psychotherapy
2006
Completed Phase 3
~200
Naltrexone
FDA approved
Brief Behavioral Compliance Enhancement Therapy
2006
Completed Phase 3
~200
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Research Foundation for Mental Hygiene, Inc.Lead Sponsor
66 Previous Clinical Trials
20,718 Total Patients Enrolled
3 Trials studying Alcoholism
390 Patients Enrolled for Alcoholism

Media Library

Brief Behavioral Compliance Enhancement Therapy (Other) Clinical Trial Eligibility Overview. Trial Name: NCT01115894 — Phase 3
Alcoholism Research Study Groups: active medication + psychotherapy, placebo + psychotherapy, active medication+brief supportive counseling, placebo + brief supportive counseling
Alcoholism Clinical Trial 2023: Brief Behavioral Compliance Enhancement Therapy Highlights & Side Effects. Trial Name: NCT01115894 — Phase 3
Brief Behavioral Compliance Enhancement Therapy (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01115894 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA cleared Modified Behavioral Self-Control Psychotherapy for public use?

"There is some evidence from previous Phase 3 trials to suggest that Modified Behavioral Self-Control Psychotherapy is safe and effective. Consequently, our team has given it a score of 3."

Answered by AI

Who would be a candidate for participating in this research project?

"The research team is looking for 200 individuals that struggle with alcoholism and fit the following profile: Between 18-65 years old, sexually active with other men, and willing to commit to reducing their alcohol consumption to safe levels."

Answered by AI

Are there any other research papers that explore Modified Behavioral Self-Control Psychotherapy?

"Currently, there are 52 ongoing clinical trials for Modified Behavioral Self-Control Psychotherapy with 16 of those in Phase 3. New york, New York has the most trials for this research with 175 locations in total."

Answered by AI

Is this study seeking participants of all ages, or only those over a certain age?

"According to the inclusionary requirements set out by the research team, patients that fall between the ages of 18 and 65 are eligible to apply for this trial. There are 24 similar trials for patients below 18 and 239 for patients above the age of 65."

Answered by AI

Are we still taking people in for this research project?

"This study is not currently looking for enrollees. It was first posted on February 1st, 2007 and was last edited on December 6th, 2012. However, there are 267 other trials concerning alcohol dependency and 52 for Modified Behavioral Self-Control Psychotherapy that are actively recruiting patients."

Answered by AI

How many people can join this trial at most?

"The trial has concluded its recruitment drive and is no longer looking for participants. The study was first posted on February 1st, 2007 and was last updated December 6th, 2012. However, there are presently 267 trials actively searching for participants with alcohol dependency and 52 studies for Modified Behavioral Self-Control Psychotherapy that are still recruiting patients."

Answered by AI

What sort of patients does Modified Behavioral Self-Control Psychotherapy help?

"Modified Behavioral Self-Control Psychotherapy is an evidence-based intervention for chronic weight management that can also help patients struggling with pain, reduced-calorie diet, and lack of physical activity."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Medication and Counseling for Controlled Drinking
Jon Morgenstern, Ph.D. 2007. "Medication and Counseling for Controlled Drinking". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01115894.
All > Alcoholism
~11 spots leftby Apr 2025
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