StuDy AimED at Increasing AlCohol AbsTinEnce

Description

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

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

StuDy AimED at Increasing AlCohol AbsTinEnce (DEDICATE)

StuDy AimED at Increasing AlCohol AbsTinEnce

Condition
Alcohol Use Disorder
Intervention / Treatment

-

Contacts and Locations

Chicago

University of Illinois at Chicago, Chicago, Illinois, United States, 60608

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 24 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Illinois at Chicago,

Hagar Hallihan, PRINCIPAL_INVESTIGATOR, University of Illinois at Chicago

Study Record Dates

2028-05-31