Evaluating Interventions for Alcohol Use Disorder

August 18, 2021 updated by: Patrick R. Clifford (PI), Rutgers, The State University of New Jersey
The purpose of this study is to investigate how behavioral treatments for alcohol use disorders affect behavior change.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers University School of Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: Study inclusion criteria are such that study participants must:

  1. meet a Diagnostic and Statistical Manual-IV (DSM-IV) alcohol abuse or dependence diagnosis based on the Diagnostic Interview Schedule - IV (DIS-IV);
  2. consume a weekly average of at least 24 standard drinks during the baseline period to include at least 5 episodes of heavy drinking;
  3. agree not to seek additional alcohol or other substance abuse treatment during the study period;
  4. be at least 18 years of age; and
  5. be sufficiently proficient in their English speaking ability to interact effectively with the research interviewer.

Exclusion Criteria:

  • Individuals assessed as having a drug diagnosis that is more severe than their alcohol diagnosis (e.g., cocaine dependence and alcohol abuse, IV drug use),
  • a serious psychiatric diagnosis (e.g., uncontrolled schizophrenia or major depression) as well as those meeting criteria for organic brain impairment, as measured by the mini-mental status examination section of the DIS-IV will be precluded from study participation.

In addition,

  • individuals reporting current enrollment in a substance abuse treatment program,
  • mandated to substance abuse treatment by a court order, or
  • severely socially unstable (e.g., homeless) also will be precluded from study participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Study participants receive either motivational enhancement therapy (MET) or cognitive behavioral therapy (CBT).
Behavioral: Motivational Enhancement Therapy
The motivational enhancement therapy will be delivered according to the Project MATCH manual.
Behavioral: Cognitive Behavioral Therapy
The cognitive behavioral therapy will be delivered according to the Project MATCH manual.
Experimental: Assessment
IB Assessment study participants receive semi-annual assessments specific to their alcohol and other drug use and FC Assessment study participants receive quarterly assessments specific to diverse areas of functioning (e.g., alcohol and other drug use, social, occupational, legal, psychological/psychiatric, marital).
Other: FC Assessment
FC Assessment study participants are exposed to quarterly assessments across broad domains of functioning.
Other: IB Assessment
IB Assessment study participants are exposed to semi-annual alcohol specific assessments

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alcohol Use
Time Frame: One year post-treatment
Alcohol use will be measured as percent days abstinent, mean drinks per drinking day, and percent heavy drinking days for study months 3 - 15 (one year post-treatment).
One year post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rutgers, The State University of New Jersey

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Syracuse University
Pacific Institute for Research and Evaluation

Investigators

  • Principal Investigator: Patrick R Clifford, PhD, Rutgers University School of Public Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Actual)

June 1, 2021

Study Completion (Actual)

July 31, 2021

Study Registration Dates

First Submitted

April 1, 2015

First Submitted That Met QC Criteria

April 6, 2015

First Posted (Estimate)

April 7, 2015

Study Record Updates

Last Update Posted (Actual)

August 19, 2021

Last Update Submitted That Met QC Criteria

August 18, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro2013003944
  • 1R01AA022330-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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