Clinical Course of Alcohol Use Disorder Recovery

NCT05607290 | Active Not Recruiting DMC

• 1 other identifier: 1R01AA030005-01A1
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (3)

• Heavy Drinking Days (Timeline Follow-back assessment)

  Change in self-report percentage of Heavy Drinking Days, completed during interview with a research assistant.

  Administered at several timepoints during the study - weekly during treatment (first 3-months), biweekly (1-year following treatment), 3- and 6-month intervals (through completion of study, average between 24-48 months depending on enrollment date)

• Short Inventory of Problems-Alcohol (SIP-A)

  Self-report questionnaire that will measure change in negative consequences (e.g., quality of work has suffered due to alcohol, physical health has been harmed due to drinking, family has been hurt due to drinking) associated with alcohol use. Scores range from 0-45, with higher numbers indicating greater negative consequences associated with alcohol use.

  Administered at several timepoints during the study - weekly during treatment (first 3-months), biweekly (1-year following treatment), 3- and 6-month intervals (through completion of study, average between 24-48 months depending on enrollment date)

• Alcohol Dependence Scale (ADS)

  Self-re\[port questionnaire will be used to measure change in the severity of alcohol dependence (e.g., frequency of hangovers, presence of withdrawal symptoms) - Scores range from 0 to 47, with higher scores indicating greater alcohol dependence severity.

  Administered at several timepoints during the study - weekly during treatment (first 3-months), biweekly (1-year following treatment), 3- and 6-month intervals (through completion of study, average between 24-48 months depending on enrollment date)

Secondary Outcomes (2)

• World Health Organization Quality of Life Scale-BREF (WHOQOL-BREF)

  Administered at several timepoints during the study - Baseline, End of Treatment, 3- and 6-month intervals (through completion of study, average between 24-48 months depending on enrollment date)

• 12-Item Short-Form Health Survey (SF-12)

  Administered at several timepoints during the study - Baseline, End of Treatment, 3- and 6-month intervals (through completion of study, average between 24-48 months depending on enrollment date)

Study Arms (1)

Treatment

OTHER

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

Behavioral: Cognitive-Behavioral Treatment

Interventions

Cognitive-Behavioral Treatment BEHAVIORAL

12 sessions of Cognitive-Behavioral Treatment for Alcohol Use Disorder

Treatment

Eligibility Criteria

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

You may qualify if:

• current diagnosis of AUD (initial screening AUDIT ≥ 8, confirmed with diagnostic interview),
• live within commuting distance of the program site,
• provide informed consent.

You may not qualify if:

• acute psychosis or severe cognitive impairment (assessed via Psychotic Module of the M.I.N.I and Mini-Mental State ≤ 23),
• current drug use diagnosis other than nicotine or marijuana use disorders,
• lack of sufficient familiarity with the English language to comprehend the recruitment and consent procedures,
• legally mandated to attend treatment

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

University of South Florida

Tampa, Florida, 33620, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: November 7, 2022
• Study Start: May 9, 2023
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Per NIAAA data sharing policy, there will be a 2-year embargo on data uploaded to the archive (i.e., data will only be shared 2 years after the grant end date on the initial NOA).
• Access Criteria: Researchers can request de-identified data stored on NIAAA's data archive via submission of a data access request. Researchers (and the institution to which they belong) who requests data must promise to keep data safe and promise not to try to learn the identity of individual study records. Researchers submitting Data Access Requests must be sponsored by an NIH recognized institution (with a FWA) and have a research-related need to access NDA data. Request includes an NDA Data Use Certification signed by the lead recipient and an authorized Signing Official from the recipient's research institution. Data Access Requests for a given NDA Permission Group are reviewed by an NIH-staffed Data Access Committee.

Locations

US (1)