Clinical Course of Alcohol Use Disorder Recovery

NCT ID: NCT05607290

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-09
• Study Completion Date: 2027-08-31

Brief Summary

The goal of this single-arm clinical trial is to better understand the ways in which individuals seeking treatment recover from Alcohol Use Disorder (AUD). The main aims are to:

• To establish operational definitions of types of change in relation to National Institute on Alcohol Abuse and Alcoholism's (NIAAA) new definition of recovery, and to distinguish between treatment response, remission versus recovery, and relapse versus recurrence.
• To describe patterns of recovery, including the frequency of within-person transitions between types of change in clinical course to better understand the dynamic nature of recovery.
• To examine the predictive relationships between theoretically important cognitive, behavioral, and affective process variables and changes during recovery, with a focus on how people initiate versus maintain change.

Participants will:

• Receive 12 weeks of psychotherapy for Alcohol Use Disorder
• Complete brief assessments after each treatment session.
• Complete brief assessments bi-weekly via phone for 1-year following treatment.
• Complete in-person interviews at 3 or 6-month intervals post-treatment.

Detailed Description

The aim of the current application is to examine the utility and validity of National Institute on Alcohol Abuse and Alcoholism's (NIAAA)new definition of recovery within the context of a novel theoretical model. The proposed study will recruit participants seeking treatment for Alcohol Use Disorder (AUD) from the community. Participants will complete a structured clinical interview and provide information on their current alcohol use and related behaviors. All participants will receive 12 weeks of AUD psychotherapy and complete brief assessments at the end of each treatment session and biweekly during the first 12-months post treatment. In addition, participants will complete in-person interviews at 3-month and 6-month intervals post-treatment for the duration of the study (for up to 24-54 months post treatment depending on time of enrollment). Findings from the proposed research have the potential to increase understanding of the dynamic nature of recovery and thereby improve clinical decision-making and generate future research. Specifically, our goal is to address the question of "Are the constructs of relapse, recurrence remission, or recovery useful heuristics for clinical practice and research, and if so, how?"

Conditions

Alcohol Use Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Empirical supported psychotherapy for alcohol use disorder (Cognitive-Behavioral Therapy, Motivational Interviewing).

Group Type: OTHER

Cognitive-Behavioral Treatment

Intervention Type: BEHAVIORAL

12 sessions of Cognitive-Behavioral Treatment for Alcohol Use Disorder

Interventions

Cognitive-Behavioral Treatment

12 sessions of Cognitive-Behavioral Treatment for Alcohol Use Disorder

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. current diagnosis of AUD (initial screening AUDIT ≥ 8, confirmed with diagnostic interview),

2. live within commuting distance of the program site,

3. provide informed consent.

Exclusion Criteria

1. acute psychosis or severe cognitive impairment (assessed via Psychotic Module of the M.I.N.I and Mini-Mental State ≤ 23),

2. current drug use diagnosis other than nicotine or marijuana use disorders,

3. lack of sufficient familiarity with the English language to comprehend the recruitment and consent procedures,

4. legally mandated to attend treatment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of South Florida

OTHER

Sponsor Role: lead

Responsible Party

Robert Schlauch

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of South Florida

Tampa, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Robert C Schlauch, PhD

Role: CONTACT

rschlauch@usf.edu

813-974-4767

Facility Contacts

Robert Schlauch, PhD

Role: primary

rschlauch@usf.edu

8139744767

Other Identifiers

1R01AA030005-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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