Brief Digitally-Enhanced Intervention for Reducing Alcohol Use During MOUD

Phase 2

Recruiting

• Conditions: Opioid Use Disorder

• Registration Number: NCT06718491
• Lead Sponsor: Ohio State University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-02
• Study First Submitted QC: 2024-12-02
• Study First Posted: 2024-12-05
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-21
• Study Start: 2025-07
• Primary Completion: 2027-07
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Self-reported Intolerance of Uncertainty	Change from baseline to post-treatment (week 4)	The Intolerance of Uncertainty- Short Form is a gold-standard self-report assessment. Subscale scores on the measure range from 7-35 for 'prospective intolerance of uncertainty' and 5-25 for 'inhibitory intolerance of uncertainty', with higher scores indicating greater intolerance of uncertainty.
Alcohol Use	Change from baseline to post-treatment (week 4)	Changes in proportion of heavy drinking days and drinks per drinking day following the intervention.
Startle eyeblink potentiation during unpredictable threat	Change from baseline to post-treatment (week 4)	Startle eyeblink potentiation will be collected during the No-, Predictable-, Unpredictable -Threat (NPU) startle paradigm. Startle is a cross-species index of aversive reactivity. Startle during unpredictable threat is an objective indicator of response to uncertain stress.
Late positive potential when viewing anxiety sensitivity evoking images	Change from baseline to post-treatment (week 4)	The late positive potential will be collected from the emotional picture paradigm. The late positive potential captures emotional reactivity. Emotional reactivity to a battery of anxiety sensitivity-evoking images is an objective indicator of response to bodily anxiety sensations.
Self-reported Anxiety Sensitivity	Change from baseline to post-treatment (week 4)	The Anxiety Sensitivity Index-3 scale is a gold standard self-report assessment. Scores range from 0 to 72 where higher scores indicate higher anxiety sensitivity.

Secondary Outcome Measures

Name	Time	Method
Medication Adherence	Change from baseline to post-treatment (week 4)	Changes in proportion of days compliant with medication for opioid use disorder.
Distress-related alcohol use	Assessed multiple times a day for 21 days	Participants will report their psychological distress and subsequent alcohol use behavior.
Daily alcohol craving	Assessed multiple times a day for 21 days	Participants will report their alcohol craving throughout each day.

Trial Locations

Locations (1)

Ohio State University; 🇺🇸 Columbus, Ohio, United States