Recruiting

Alcohol AbstinenceStuDy AimED at Increasing AlCohol AbsTinEnce

Sponsor:

University of Illinois at Chicago

Code:

NCT05778734

Conditions

Alcohol Use Disorder

Eligibility Criteria

Sex: All

Age: 18 - 24

Healthy Volunteers: Accepted

Interventions

CM-PST

CM only

Study Details

Brief summary:

The goal of this clinical trial is to test the feasibility \& acceptability of an integrated CM-PST intervention (in K99 phase) and preliminary efficacy (in R00 phase), vs. CM alone, to improve treatment efficacy and inform about neural mechanisms of treatment effects in young adults with Alcohol Use Disorder (AUD).

The aims are as follows:

K99 Aim: Test feasibility \& acceptability of a developed CM-PST, by meeting these benchmarks: 2a Feasibility: enroll 20 participants in the new CM-PST in a single-arm pre- and post-study, and retain ≥85% at wk 12. 2b Deliver CM-PST at ≥90% fidelity to intervention protocol. 2c Acceptability to participants: Achieve mean score ≥3 on Client Satisfaction Scale Questionnaire and satisfaction from semi-structured interviews.

R00 Aim 1) Test preliminary efficacy of CM-PST in a 2-arm pilot RCT: Male/female young adults (aged18-24) who meet AUD criteria will be randomized to CM-PST or CM-only control, and assessed at baseline (0), 3, and 6 months. Primary study endpoint will be 3 months.

R00 Aim 2 (Exploratory) Explore potential neural mechanisms of CM-PST effects, by fMRI scanning \& analyses of core regions of the brain circuits regulating positive affect (ventral striatum), negative affect (amygdala), and cognitive control (dorsolateral prefrontal cortex), and connectivity between these core regions.

Conditions

Alcohol Use Disorder

Study ID

NCT05778734

Start date

Jul 30, 2023

Status verified date

May, 2026

Completion date

Apr 30, 2028

Anticipated

Primary completion date

Dec 30, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 24

Healthy Volunteers: Accepted

Inclusion Criteria:

Male and female young adults aged 18-24 yr
English-speaking
Current alcohol use greater or equal to 1 day/week via phone screening, and meet criteria for (past year) mild, moderate or severe AUD on the AUDIT and AUDADIS surveys.
Completion of written informed consent
Baseline screening study visit.

Exclusion Criteria:

Participation in past 6 mo. in AUD or substance use treatment
Current use of medications used to treat AUD (e.g., naltrexone)
Lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder.
Current use of psychoactive drugs, determined by positive drug toxicology screen
Conditions (e.g., tic disorder) that would interfere with psychophysiological indices of reward functioning
Pregnancy or intention to become pregnant
Additional exclusion criteria pertaining to fMRI scan in R00 phase only: a) bodily ferrous metals (e.g., aneurysm clips, shrapnel/retained particles) or b) claustrophobia, inability to tolerate small enclosed spaces.

Study Design

Enrollment

104 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Treatment group

For the R00 phase: CM-PST treatment group will receive CM-PST intervention, which will consist of 8 sessions total, delivered remotely via Zoom videoconferences in individual sessions over 12 weeks. The first 4 sessions will be delivered weekly, and the remaining 4 sessions every other week. CM-PST will teach participants problem-solving skills using a structured 5-step method. In addition, participants will receive incentives for alcohol abstinence and submission of urine samples twice/wk.

K99 phase participants will also receive CM-PST intervention.

other: Control group

For the R00 phase: Participants in CM-only control will receive incentives for alcohol abstinence and submission of urine samples twice/wk. Participant incentives will start at a $10 gift card, with a $5 increase each subsequent measurement point on which alcohol is not detected or reported, to a maximum of $25, but no gift card on days when alcohol use is detected or reported, and the gift card reinforcer value will be re-set to $10.

Interventions

CM-PST

CM-PST is a tailored behavioral intervention that enables young adults with AUD to successfully manage and overcome everyday life challenges influencing their alcohol intake.

CM only

CM is a behavior therapy that rewards individuals for evidence of positive change (alcohol abstinence).

Primary outcome measure

Alcohol abstinence. [ Time Frame: Up to 6months ]

Central Contacts and Locations

Central contacts

Hagar Hallihan, PhD

312-413-5361 hhalli2@uic.edu

Locations

University of Illinois at Chicago

Recruiting

Chicago, Illinois, United States, 60608

More Information

Sponsor

University of Illinois at Chicago

Last update posted

May 7, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Illinois at Chicago on 2026-05-07.