Evaluating Interventions for Alcohol Use Disorder

NCT ID: NCT02409888

Last Updated: 2021-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2021-07-31

Brief Summary

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

Detailed Description

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Conditions

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Alcoholism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

Motivational Enhancement Therapy

Intervention Type BEHAVIORAL

The motivational enhancement therapy will be delivered according to the Project MATCH manual.

Cognitive Behavioral Therapy

Intervention Type BEHAVIORAL

The cognitive behavioral therapy will be delivered according to the Project MATCH manual.

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).

Group Type EXPERIMENTAL

FC Assessment

Intervention Type OTHER

FC Assessment study participants are exposed to quarterly assessments across broad domains of functioning.

IB Assessment

Intervention Type OTHER

IB Assessment study participants are exposed to semi-annual alcohol specific assessments

Interventions

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Motivational Enhancement Therapy

The motivational enhancement therapy will be delivered according to the Project MATCH manual.

Intervention Type BEHAVIORAL

Cognitive Behavioral Therapy

The cognitive behavioral therapy will be delivered according to the Project MATCH manual.

Intervention Type BEHAVIORAL

FC Assessment

FC Assessment study participants are exposed to quarterly assessments across broad domains of functioning.

Intervention Type OTHER

IB Assessment

IB Assessment study participants are exposed to semi-annual alcohol specific assessments

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Syracuse University

OTHER

Sponsor Role collaborator

Pacific Institute for Research and Evaluation

OTHER

Sponsor Role collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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Patrick R. Clifford (PI)

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Patrick R Clifford, PhD

Role: PRINCIPAL_INVESTIGATOR

Rutgers University School of Public Health

Locations

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Rutgers University School of Public Health

New Brunswick, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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1R01AA022330-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro2013003944

Identifier Type: -

Identifier Source: org_study_id

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