StuDy AimED at Increasing AlCohol AbsTinEnce

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-30

Study Completion Date

2028-05-31

Brief Summary

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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.

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Detailed Description

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Study Design Formative (K99 Phase), we will test feasibility \& acceptability of integrated CM-PST. To test CM-PST, we will recruit/enroll 20 participants in a single-arm pre/post study. Participants who meet eligibility will be invited to our clinical lab at UIC for informed consent and baseline measures. Consenting participants will receive CM-PST intervention via videoconferences such as zoom, in 8 CM-PST individual sessions, every week for sessions 1-4 and every other week for sessions 5-8, over 12 weeks. Participants will complete the Client Satisfaction Scale survey after each session and 3 mo. post-intervention, to quantify their overall experiences with this new CM-PST.

Preliminary efficacy trial (R00 Phase). This will be a 2-arm Randomized control trial in young adults aged 18-24 yr who meet AUD criteria. Prospective participants who respond to our advertisements will be screened by phone for eligibility and to determine their AUD diagnostic status and severity (mild, moderate, severe). Participants who meet eligibility will be invited to our UIC clinical lab for informed consent, baseline self-report measures, urine alcohol screening, and baseline fMRI, and then randomized to either CM-PST (42 participants) or CM-only (42 participants) control group. All participants will complete follow-up assessments at 3 \& 6 months with blinded outcome assessors.

Conditions

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Alcohol Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

K99 Phase is a single arm study, whiles the R00 phase is a 2-arm study.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type OTHER

CM-PST

Intervention Type 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.

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.

Group Type OTHER

CM only

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

CM only

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes