Clinical trial NCT05607290: Clinical Course of Alcohol Use Disorder Recovery
Official title: Clinical Course of Alcohol Use Disorder Recovery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2022-11-07
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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?"

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

Primary outcomes:
measure: Heavy Drinking Days (Timeline Follow-back assessment)
timeFrame: 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)
measure: Short Inventory of Problems-Alcohol (SIP-A)
timeFrame: 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)
measure: Alcohol Dependence Scale (ADS)
timeFrame: 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:
measure: World Health Organization Quality of Life Scale-BREF (WHOQOL-BREF)
timeFrame: 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)
measure: 12-Item Short-Form Health Survey (SF-12)
timeFrame: 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)
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
Study officials:
References: