Evaluating Interventions for Alcohol Use Disorder

NCT02409888 | Completed DMC

• 2 other identifiers: Pro20130039441R01AA022330-01A1
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alcoholism

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: Motivational Enhancement Therapy; Behavioral: Cognitive Behavioral Therapy

Assessment

EXPERIMENTAL

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; Other: IB Assessment

Interventions

Motivational Enhancement Therapy BEHAVIORAL

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

Intervention

Cognitive Behavioral Therapy BEHAVIORAL

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

Intervention

FC Assessment OTHER

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

Assessment

IB Assessment OTHER

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

Assessment

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• Syracuse University: collaborator
• Pacific Institute for Research and Evaluation: collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Rutgers University School of Public Health

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Motivational Interviewing; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services; Behavior Therapy; Psychotherapy

Study Officials

• Patrick R Clifford, PhD

  Rutgers University School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 1, 2015
• First Posted: April 7, 2015
• Study Start: November 1, 2015
• Primary Completion: June 1, 2021
• Study Completion: July 31, 2021
• Last Updated: August 19, 2021

Record last verified: 2021-08

Locations

US (1)