Alcohol Use DisorderNCT05607290
Clinical Course of Alcohol Use Disorder Recovery
A study testing Cognitive-Behavioral Treatment in people with Alcohol Use Disorder, run by University of South Florida at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Cognitive-Behavioral Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2023to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- current diagnosis of AUD (initial screening AUDIT ≥ 8, confirmed with diagnostic interview),
- live within commuting distance of the program site,
- provide informed consent.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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?"
- Conditions
- Alcohol Use Disorder
- Being tested
- Cognitive-Behavioral Treatment
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Behavioral TreatmentBehavioural
12 sessions of Cognitive-Behavioral Treatment for Alcohol Use Disorder
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Other | Empirical supported psychotherapy for alcohol use disorder (Cognitive-Behavioral Therapy, Motivational Interviewing). Receives: Behavioral: Cognitive-Behavioral Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heavy Drinking Days (Timeline Follow-back assessment)
Change in self-report percentage of Heavy Drinking Days, completed during interview with a research assistant.
Measured: 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.
Measured: 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.
Measured: 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)
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.
Measured: 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)
Self-report questionnaire measuring change in overall physical and mental health. Scores range from 0-100, with higher scores indicating greater health related problems.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start17 May 2023
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Schlauch, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05607290
- Sponsor's protocol ID
- 1R01AA030005-01A1
- Status last verified
- Jul 2026
- First submitted
- 17 Oct 2022
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Course of Alcohol Use Disorder Recovery
- ClinicalTrials.gov ID
- NCT05607290
- Acronym / sponsor ID
- 1R01AA030005-01A1
- Conditions
- Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- 17 May 2023 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 7 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?"
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Other | Behavioral: Cognitive-Behavioral TreatmentEmpirical supported psychotherapy for alcohol use disorder (Cognitive-Behavioral Therapy, Motivational Interviewing). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- current diagnosis of AUD (initial screening AUDIT ≥ 8, confirmed with diagnostic interview),
- live within commuting distance of the program site,
- provide informed consent.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-Behavioral Treatment12 sessions of Cognitive-Behavioral Treatment for Alcohol Use Disorder | Behavioural | Treatment |
Primary outcome
Heavy Drinking Days (Timeline Follow-back assessment)
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)
Change in self-report percentage of Heavy Drinking Days, completed during interview with a research assistant.
Short Inventory of Problems-Alcohol (SIP-A)
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)
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)
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)
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.
2 secondary outcomes
World Health Organization Quality of Life Scale-BREF (WHOQOL-BREF)
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)
12-Item Short-Form Health Survey (SF-12)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-Behavioral Treatment in people with Alcohol Use Disorder, run by University of South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heavy Drinking Days (Timeline Follow-back assessment) (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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.