Evaluating Interventions for Alcohol Use Disorder

Alcoholism Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02409888
• Other study ID #: Pro2013003944
• Secondary ID: 1R01AA022330-01A
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: July 31, 2021

Study information

• Verified date: August 2021
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: July 31, 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alcoholism

Intervention

Behavioral:
• Motivational Enhancement Therapy
The motivational enhancement therapy will be delivered according to the Project MATCH manual.
• Cognitive Behavioral Therapy
The cognitive behavioral therapy will be delivered according to the Project MATCH manual.

Other:
• FC Assessment
FC Assessment study participants are exposed to quarterly assessments across broad domains of functioning.
• IB Assessment
IB Assessment study participants are exposed to semi-annual alcohol specific assessments

Locations

Country	Name	City	State
United States	Rutgers University School of Public Health	New Brunswick	New Jersey

Sponsors (4)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Institute on Alcohol Abuse and Alcoholism (NIAAA), Pacific Institute for Research and Evaluation, Syracuse University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	One year post-treatment