StuDy AimED at Increasing AlCohol AbsTinEnce

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Illinois at Chicago
Study ID
NCT05778734
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 24 Years
Healthy Volunteers
Accepted

Interventions

  • CM-PST — BEHAVIORAL
    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 — BEHAVIORAL
    CM is a behavior therapy that rewards individuals for evidence of positive change (alcohol abstinence).

Study Details

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.

Key Dates

Start date
Jul 30, 2023
Status verified
May 2026
Primary completion
Dec 30, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
104 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Illinois at ChicagoChicagoIllinois60608
Hagar Hallihan

Find similar trials in Chicago, IL

By condition
Substance use disorder
By specialty
Behavioral healthAddiction medicine
By research site
University of Illinois at Chicago· Chicago, IL

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