RECRUITINGINTERVENTIONAL

StuDy AimED at Increasing AlCohol AbsTinEnce

StuDy AimED at Increasing AlCohol AbsTinEnce (DEDICATE)

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form - Baseline screening study visit. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

BEHAVIORAL

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.

BEHAVIORAL

CM only

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

Locations (1)

University of Illinois at Chicago

Chicago, Illinois, United States