Brief Digitally-Enhanced Intervention for Reducing Alcohol Use During MOUD

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University
Study ID
NCT06718491
Phase
PHASE2
Status
Recruiting
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Conditions

  • Opioid Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Managing Physical Reactions to Overwhelming Emotions (IMPROVE) — BEHAVIORAL
    Participants may be randomized to IMPROVE. IMPROVE is a three session virtual intervention delivered by research clinicians and augmented by a mobile application. The treatment is designed to target and reduce distress contributing to heavy alcohol use during medication for opioid use disorder treatment.
  • Health Education Training (HET) — BEHAVIORAL
    Participants may be randomized to HET. HET is an active control intervention that is equally intensive as IMPROVE It includes three virtual sessions and a mobile application. HET is designed to target healthy lifestyle behaviors such as diet and sleep.

Study Details

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.

Key Dates

Start date
Aug 1, 2025
Status verified
Aug 2025
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Managing Physical Reactions to Overwhelming Emotions (IMPROVE)
    In this arm, participants will receive the IMPROVE intervention, a clinician-delivered protocol targeting anxiety and uncertainty.
  • Active Comparator: Health Education Training (HET)
    In this arm, participants will receive a clinician-delivered protocol with a digital component, called HET. HET focuses on healthy living more broadly and does not include information about anxiety or uncertainty.

Primary Outcome Measure

Alcohol Use [ Time Frame: Change from baseline to post-treatment (week 4) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State UniversityColumbusOhio43210
Stephanie Gorka, PhD
[email protected]
614-366-1027

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By research site
Ohio State University· Columbus, OH

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