Medication and Counseling for Controlled Drinking (Project SMART)

NCT00444418 | Completed Phase 3 DMC

• 2 other identifiers: NIAAAMOR_015553-01A1S1NIH Grant AA015553-01A1S1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Quantity of alcohol use

  9 months

• Frequency of binge drinking

  9 months

Secondary Outcomes (1)

• Frequency of HIV risk behavior

  9 months

Study Arms (4)

1

EXPERIMENTAL

Active medication (Naltrexone) combined with Modified Behavioral Self-Control Psychotherapy

Drug: Naltrexone; Behavioral: Modified Behavioral Self-Control Psychotherapy; Behavioral: Brief Behavioral Compliance Enhancement Therapy

2

EXPERIMENTAL

Placebo combined with Modified Behavioral Self-Control Psychotherapy

Behavioral: Modified Behavioral Self-Control Psychotherapy; Behavioral: Brief Behavioral Compliance Enhancement Therapy

3

EXPERIMENTAL

Active medication (Naltrexone) combined with Brief Behavioral Compliance Enhancement Therapy

Drug: Naltrexone; Behavioral: Brief Behavioral Compliance Enhancement Therapy

4

PLACEBO COMPARATOR

Placebo + Brief Behavioral Compliance Enhancement Therapy

Behavioral: Brief Behavioral Compliance Enhancement Therapy

Interventions

Naltrexone DRUG

Naltrexone, 100 mg. oral dosage, daily for 12 weeks.

Also known as: Naloxone, Revia, Depade

1; 3

Modified Behavioral Self-Control Psychotherapy BEHAVIORAL

Moderation- and cognitive-behaviorally-based psychotherapy. Treatment goal of moderation of alcohol consumption. 12 weekly, 1-hour sessions.

1; 2

Brief Behavioral Compliance Enhancement Therapy BEHAVIORAL

Brief supportive counseling to enhance compliance with medication and encourage goal-setting concerning alcohol consumption

1; 2; 3; 4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA): lead

Study Sites (1)

Research Foundation for Mental Hygiene, Columbia Addiction Services and Psychotherapy Intervention Research, 3 Columbus Circle, Suite 1404

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Alcohol-Related Disorders; Alcohol Drinking; Alcoholism

Interventions

Naltrexone; Naloxone

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Jon Morgenstern, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Investigator

Study Record Dates

• First Submitted: March 6, 2007
• First Posted: March 7, 2007
• Study Start: April 1, 2006
• Primary Completion: February 1, 2010
• Study Completion: June 1, 2010
• Last Updated: May 1, 2013

Record last verified: 2013-04

Locations

US (1)