RECRUITING

Brief Digitally-Enhanced Intervention for Reducing Alcohol Use During MOUD

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 reduce heavy drinking and enhance medication for opioid use disorder (MOUD) outcomes in individuals receiving MOUD. The main questions it aims to answer are: * Does the brief, digitally-enhanced, virtual psychotherapeutic intervention, called Managing Physical Reactions to Overwhelming Emotions (IMPROVE), impact daily alcohol use and MOUD adherence? * Does the intervention change self-report and physiological responses to intolerance to uncertainty and anxiety sensitivity? Researchers will compare IMPROVE to a control intervention (health education treatment) to see if IMPROVE impacts daily alcohol use and MOUD adherence. Participants will: * Complete a baseline electroencephalography (EEG) and self-report questionnaires. * Complete three one-hour intervention sessions (IMPROVE or control) each one week a part. * Complete a post-intervention EEG and self-report questionnaires. * Complete five ecological momentary assessment (EMA) surveys a day for 21 days. * Complete self-report questionnaires one-month after their last intervention session.

Official Title

Brief Digitally-Enhanced Intervention for Managing Emotional Pain and Reducing Alcohol Use During Medication for OUD

Quick Facts

Study Start:2025-03
Study Completion:2027-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06718491

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
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Enrolled in outpatient medication for opioid use disorder (MOUD) program (within the past month)
  2. * Heavy alcohol user defined using the National Institute on Alcohol Abuse and Alcoholism (NIAAA) criteria (i.e., consume 8+/15+ drinks per week \[women/men\] with at least two binge episodes \[4/5+ drinks for women/men in a 2 hour period\] in the past month)
  3. * Elevated psychological distress defined as a total score of \> 12 on the Kessler Psychological Distress Scale (K10; 0 to 40 range)
  4. * 18 years of age or older
  5. * Can read and comprehend English
  1. * Do not pass the informed decision-making capacity screener, suggesting cognitive impairment or an inability to provide informed consent
  2. * Presence of a psychiatric or medical condition that would prevent them from providing informed consent or participating in the treatments (e.g., psychosis, mania, acute intoxication)
  3. * Current comorbid moderate to severe substance use disorder other than alcohol and opioids
  4. * Limited or no access to a smart phone that is compatible with the mobile application
  5. * Participation in Phase One
  6. * Possibility of being pregnant (by self-report)
  7. * Current suicidal or homicidal intent indicating a need for immediate hospitalization or treatment as determined by clinical interviewer

Contacts and Locations

Study Contact

Stephanie Gorka, PhD
CONTACT
614-366-1027
stephanie.gorka@osumc.edu

Study Locations (Sites)

Ohio State University
Columbus, Ohio, 43210
United States

Collaborators and Investigators

Sponsor: Ohio State University

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 Date2025-03
Study Completion Date2027-07

Study Record Updates

Study Start Date2025-03
Study Completion Date2027-07

Terms related to this study

Keywords Provided by Researchers

  • Medications for Opioid Use Disorder
  • Heavy Alcohol Use
  • Ecological Momentary Assessments
  • Electroencephalography

Additional Relevant MeSH Terms

  • Opioid Use Disorder