Actively Recruiting

Phase Not Applicable
Age: 18Years - 24Years
All Genders
Healthy Volunteers
NCT05778734

StuDy AimED at Increasing AlCohol AbsTinEnce

Led by University of Illinois at Chicago · Updated on 2026-05-07

104

Participants Needed

1

Research Sites

248 weeks

Total Duration

On this page

Sponsors

U

University of Illinois at Chicago

Lead Sponsor

N

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

StuDy AimED at Increasing AlCohol AbsTinEnce

Who Can Participate

Age: 18Years - 24Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male and female young adults aged 18-24 years
  • English-speaking
  • Current alcohol use at least 1 day per week via phone screening
  • Meet criteria for mild, moderate, or severe AUD in the past year on AUDIT and AUDADIS surveys
  • Completion of written informed consent
  • Attendance at baseline screening visit
Not Eligible

You will not qualify if you...

  • Participation in alcohol or substance use treatment within the past 6 months
  • Current use of medications for AUD such as naltrexone
  • Lifetime diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder
  • Current use of psychoactive drugs confirmed by positive drug screen
  • Conditions interfering with reward functioning measurements (e.g., tic disorder)
  • Pregnancy or intention to become pregnant
  • For fMRI scan: presence of bodily ferrous metals or claustrophobia preventing scan tolerance

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

University of Illinois at Chicago

Chicago, Illinois, United States, 60608

Actively Recruiting

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Research Team

H

Hagar Hallihan, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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