Clinical Course of Alcohol Use Disorder Recovery

Alcohol Use Disorder Clinical Trial

Official title:

Clinical Course of Alcohol Use Disorder Recovery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05607290
• Other study ID #: 1R01AA030005-01A1
• Status: Recruiting
• Phase: N/A
• Start date: May 9, 2023
• Est. completion date: August 31, 2027

Study information

• Verified date: July 2023
• Source: University of South Florida
• Contact: Robert C Schlauch, PhD
• Phone: 813-974-4767
• Email: rschlauch[@]usf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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?"

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: August 31, 2027
• Est. primary completion date: August 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism
• Disease Progression

Intervention

Behavioral:
• Cognitive-Behavioral Treatment
12 sessions of Cognitive-Behavioral Treatment for Alcohol Use Disorder

Locations

Country	Name	City	State
United States	University of South Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	World Health Organization Quality of Life Scale-BREF (WHOQOL-BREF)	Self-report questionnaire that assesses change in overall quality of life across several domains (e.g., physical, psychological, social, environmental). Scores ranging between 0-100, with higher scores indicating higher quality of life.	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)
Secondary	12-Item Short-Form Health Survey (SF-12)	Self-report questionnaire measuring change in overall physical and mental health. Scores range from 0-100, with higher scores indicating greater health related problems.	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)