Clinical Course of Alcohol Use Disorder Recovery

University of South Florida

Status: Active, not recruiting

Conditions: Alcohol Use Disorder

Treatments: Behavioral: Cognitive-Behavioral Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT05607290

1R01AA030005-01A1

Details and patient eligibility

About

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.

Full 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?"

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 1 patient group

Treatment

Other group

Description:

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

Treatment:

Behavioral: Cognitive-Behavioral Treatment