NCT05778734 StuDy AimED at Increasing AlCohol AbsTinEnce
| NCT ID | NCT05778734 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Illinois Chicago |
| Condition | Alcohol Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 104 participants |
| Start Date | 2023-07-30 |
| Primary Completion | 2027-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 104 participants in total. It began in 2023-07-30 with a primary completion date of 2027-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Hagar Hallihan
PRINCIPAL INVESTIGATOR
University of Illinois Chicago
Frequently Asked Questions
Who can join the NCT05778734 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 24 Years, studying Alcohol Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05778734 currently recruiting?
Yes, NCT05778734 is actively recruiting participants. Contact the research team at hhalli2@uic.edu for enrollment information.
Where is the NCT05778734 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT05778734 clinical trial?
NCT05778734 is sponsored by University of Illinois Chicago. The principal investigator is Hagar Hallihan at University of Illinois Chicago. The trial plans to enroll 104 participants.