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Clinical Course of Alcohol Use Disorder Recovery

Primary Purpose

Alcohol Use Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive-Behavioral Treatment
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of South FloridaRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Treatment

Arm Description

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

Outcomes

Primary Outcome Measures

Heavy Drinking Days (Timeline Follow-back assessment)
Change in self-report percentage of Heavy Drinking Days, completed during interview with a research assistant.
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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
October 17, 2022
Last Updated
July 11, 2023
Sponsor
University of South Florida
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1. Study Identification

Unique Protocol Identification Number
NCT05607290
Brief Title
Clinical Course of Alcohol Use Disorder Recovery
Official Title
Clinical Course of Alcohol Use Disorder Recovery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 9, 2023 (Actual)
Primary Completion Date
August 31, 2027 (Anticipated)
Study Completion Date
August 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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?"

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Other
Arm Description
Empirical supported psychotherapy for alcohol use disorder (Cognitive-Behavioral Therapy, Motivational Interviewing).
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-Behavioral Treatment
Intervention Description
12 sessions of Cognitive-Behavioral Treatment for Alcohol Use Disorder
Primary Outcome Measure Information:
Title
Heavy Drinking Days (Timeline Follow-back assessment)
Description
Change in self-report percentage of Heavy Drinking Days, completed during interview with a research assistant.
Time Frame
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)
Title
Short Inventory of Problems-Alcohol (SIP-A)
Description
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.
Time Frame
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)
Title
Alcohol Dependence Scale (ADS)
Description
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.
Time Frame
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 Outcome Measure Information:
Title
World Health Organization Quality of Life Scale-BREF (WHOQOL-BREF)
Description
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.
Time Frame
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)
Title
12-Item Short-Form Health Survey (SF-12)
Description
Self-report questionnaire measuring change in overall physical and mental health. Scores range from 0-100, with higher scores indicating greater health related problems.
Time Frame
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: current diagnosis of AUD (initial screening AUDIT ≥ 8, confirmed with diagnostic interview), live within commuting distance of the program site, provide informed consent. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert C Schlauch, PhD
Phone
813-974-4767
Email
rschlauch@usf.edu
Facility Information:
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33620
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Schlauch, PhD
Phone
813-974-4767
Email
rschlauch@usf.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
In compliance with the grant funding agency (NIH/NIAAA, NOT-AA-22-011), participants who give consent will have all their de-identified survey/questionnaire data submitted and shared within the NIAAA Data Archive, which is a data repository housed within the NIMH Data Archive (NDA).
IPD Sharing 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).
IPD Sharing 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.

Learn more about this trial

Clinical Course of Alcohol Use Disorder Recovery

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