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NCT06718491 | RECRUITING | Opioid Use Disorder

Brief Digitally-Enhanced Intervention for Reducing Alcohol Use During MOUD
Sponsor:

Ohio State University

Information provided by (Responsible Party):

Stephanie M Gorka, PhD

Brief Summary:

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.

Condition or disease

Opioid Use Disorder

Intervention/treatment

Managing Physical Reactions to Overwhelming Emotions (IMPROVE)

Health Education Training (HET)

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 80 participants
Masking : SINGLE
Masking Description : Participants will be blind to the condition.
Primary Purpose : TREATMENT
Official Title : Brief Digitally-Enhanced Intervention for Managing Emotional Pain and Reducing Alcohol Use During Medication for OUD
Actual Study Start Date : 2025-08-01
Estimated Primary Completion Date : 2027-07
Estimated Study Completion Date : 2027-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Enrolled in outpatient medication for opioid use disorder (MOUD) program (within the past month)
  • * 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)
  • * Elevated psychological distress defined as a total score of \> 12 on the Kessler Psychological Distress Scale (K10; 0 to 40 range)
  • * 18 years of age or older
  • * Can read and comprehend English
Exclusion Criteria
  • * Do not pass the informed decision-making capacity screener, suggesting cognitive impairment or an inability to provide informed consent
  • * 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)
  • * Current comorbid moderate to severe substance use disorder other than alcohol and opioids
  • * Limited or no access to a smart phone that is compatible with the mobile application
  • * Participation in Phase One
  • * Possibility of being pregnant (by self-report)
  • * Current suicidal or homicidal intent indicating a need for immediate hospitalization or treatment as determined by clinical interviewer
Brief Digitally-Enhanced Intervention for Reducing Alcohol Use During MOUD

Location Details

NCT06718491

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How to Participate

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Locations

RECRUITING

United States, Ohio

Ohio State University

Columbus, Ohio, United States, 43210