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Evaluating Interventions for Alcohol Use Disorder

Primary Purpose

Alcoholism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational Enhancement Therapy
Cognitive Behavioral Therapy
FC Assessment
IB Assessment
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rutgers University School of Public Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intervention

Assessment

Arm Description

Study participants receive either motivational enhancement therapy (MET) or cognitive behavioral therapy (CBT).

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).

Outcomes

Primary Outcome Measures

Alcohol Use
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).

Secondary Outcome Measures

Full Information

First Posted
April 1, 2015
Last Updated
August 18, 2021
Sponsor
Rutgers, The State University of New Jersey
Collaborators
Syracuse University, Pacific Institute for Research and Evaluation, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT02409888
Brief Title
Evaluating Interventions for Alcohol Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
June 2021 (Actual)
Study Completion Date
July 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
Syracuse University, Pacific Institute for Research and Evaluation, National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to investigate how behavioral treatments for alcohol use disorders affect behavior change.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Study participants receive either motivational enhancement therapy (MET) or cognitive behavioral therapy (CBT).
Arm Title
Assessment
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Motivational Enhancement Therapy
Intervention Description
The motivational enhancement therapy will be delivered according to the Project MATCH manual.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
The cognitive behavioral therapy will be delivered according to the Project MATCH manual.
Intervention Type
Other
Intervention Name(s)
FC Assessment
Intervention Description
FC Assessment study participants are exposed to quarterly assessments across broad domains of functioning.
Intervention Type
Other
Intervention Name(s)
IB Assessment
Intervention Description
IB Assessment study participants are exposed to semi-annual alcohol specific assessments
Primary Outcome Measure Information:
Title
Alcohol Use
Description
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).
Time Frame
One year post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Study inclusion criteria are such that study participants must: meet a Diagnostic and Statistical Manual-IV (DSM-IV) alcohol abuse or dependence diagnosis based on the Diagnostic Interview Schedule - IV (DIS-IV); consume a weekly average of at least 24 standard drinks during the baseline period to include at least 5 episodes of heavy drinking; agree not to seek additional alcohol or other substance abuse treatment during the study period; be at least 18 years of age; and 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick R Clifford, PhD
Organizational Affiliation
Rutgers University School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers University School of Public Health
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States

12. IPD Sharing Statement

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Evaluating Interventions for Alcohol Use Disorder

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