RECRUITING

StuDy AimED at Increasing AlCohol AbsTinEnce

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

StuDy AimED at Increasing AlCohol AbsTinEnce (DEDICATE)

Quick Facts

Study Start:2023-07-30
Study Completion:2028-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05778734

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.

Ages Eligible for Study:18 Years to 24 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male and female young adults aged 18-24 yr
  2. * English-speaking
  3. * 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.
  4. * Completion of written informed consent
  5. * Baseline screening study visit.
  1. * Participation in past 6 mo. in AUD or substance use treatment
  2. * Current use of medications used to treat AUD (e.g., naltrexone)
  3. * Lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder.
  4. * Current use of psychoactive drugs, determined by positive drug toxicology screen
  5. * Conditions (e.g., tic disorder) that would interfere with psychophysiological indices of reward functioning
  6. * Pregnancy or intention to become pregnant
  7. * 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.

Contacts and Locations

Study Contact

Hagar Hallihan, PhD
CONTACT
312-413-5361
hhalli2@uic.edu

Principal Investigator

Hagar Hallihan
PRINCIPAL_INVESTIGATOR
University of Illinois at Chicago

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of Illinois at Chicago

  • Hagar Hallihan, PRINCIPAL_INVESTIGATOR, University of Illinois at Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-30
Study Completion Date2028-05-31

Study Record Updates

Study Start Date2023-07-30
Study Completion Date2028-05-31

Terms related to this study

Additional Relevant MeSH Terms

  • Alcohol Use Disorder