Brief Digitally-Enhanced Intervention for Reducing Alcohol Use During MOUD

NCT ID: NCT06718491

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2027-07-31

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.

Conditions

Opioid Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Managing Physical Reactions to Overwhelming Emotions (IMPROVE)

In this arm, participants will receive the IMPROVE intervention, a clinician-delivered protocol targeting anxiety and uncertainty.

Group Type: EXPERIMENTAL

Managing Physical Reactions to Overwhelming Emotions (IMPROVE)

Intervention Type: 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)

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.

Group Type: ACTIVE_COMPARATOR

Health Education Training (HET)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Stephanie M Gorka, PhD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ohio State University

Columbus, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Stephanie Gorka, PhD

Role: CONTACT

stephanie.gorka@osumc.edu

614-366-1027

Facility Contacts

Stephanie Gorka, PhD

Role: primary

stephanie.gorka@osumc.edu

614-366-1027

Other Identifiers

2024H0358

Identifier Type: -

Identifier Source: org_study_id