Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06718491

Brief Digitally-Enhanced Intervention for Reducing Alcohol Use During MOUD

Led by Ohio State University · Updated on 2025-08-06

80

Participants Needed

1

Research Sites

99 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Brief Digitally-Enhanced Intervention for Reducing Alcohol Use During MOUD

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Enrolled in outpatient medication for opioid use disorder (MOUD) program within the past month
  • Heavy alcohol use defined as 8+ drinks/week for women or 15+ drinks/week for men, with at least two binge episodes in the past month
  • Elevated psychological distress with a Kessler Psychological Distress Scale (K10) score greater than 12
  • 18 years of age or older
  • Able to read and understand English
Not Eligible

You will not qualify if you...

  • Unable to provide informed consent due to cognitive impairment or lack of decision-making capacity
  • Psychiatric or medical conditions preventing consent or participation (e.g., psychosis, mania, acute intoxication)
  • Current moderate to severe substance use disorder other than alcohol and opioids
  • Limited or no access to a compatible smartphone
  • Prior participation in Phase One of the study
  • Possibility of pregnancy (self-reported)
  • Current suicidal or homicidal intent requiring immediate hospitalization or treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Ohio State University

Columbus, Ohio, United States, 43210

Actively Recruiting

Loading map...

Research Team

S

Stephanie Gorka, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here