Brief Digitally-Enhanced Intervention for Reducing Alcohol Use During MOUD

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

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.

Study Overview

• Status: Recruiting
• Conditions: Opioid Use Disorder
• Intervention / Treatment: Behavioral: Managing Physical Reactions to Overwhelming Emotions (IMPROVE); Behavioral: Health Education Training (HET)

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Stephanie Gorka, PhD; Phone Number: 614-366-1027; Email: stephanie.gorka@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University
      • Contact: Stephanie Gorka, PhD; Phone Number: 614-366-1027; Email: stephanie.gorka@osumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Managing Physical Reactions to Overwhelming Emotions (IMPROVE); 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.
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.	Behavioral: Health Education Training (HET); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alcohol Use	Changes in proportion of heavy drinking days and drinks per drinking day following the intervention.	Change from baseline to post-treatment (week 4)
Startle eyeblink potentiation during unpredictable threat	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.	Change from baseline to post-treatment (week 4)
Late positive potential when viewing anxiety sensitivity evoking images	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.	Change from baseline to post-treatment (week 4)
Self-reported Intolerance of Uncertainty	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.	Change from baseline to post-treatment (week 4)
Self-reported Anxiety Sensitivity	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.	Change from baseline to post-treatment (week 4)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: December 2, 2024
• First Submitted That Met QC Criteria: December 2, 2024
• First Posted (Actual): December 5, 2024

Study Record Updates

• Last Update Posted (Actual): August 6, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Electroencephalography; Medications for Opioid Use Disorder; Ecological Momentary Assessments; Heavy Alcohol Use
• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Drinking Behavior; Opioid-Related Disorders; Alcohol Drinking
• Other Study ID Numbers: 2024H0358

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data, including electroencephalography (EEG), startle eyeblink, and behavior, from this project will be submitted to the National Institute of Mental Health Data Archive (NDA) at the subject level along with appropriate supporting documentation to enable efficient use of the data by the research community. We will follow instructions as discussed in the NDA Data Sharing Terms and Conditions.
• IPD Sharing Time Frame: The data will be submitted at the conclusion of the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No