Brief Digitally-Enhanced Intervention for Reducing Alcohol Use During MOUD

The Ohio State University

Status and phase: Enrolling; Phase 2

Conditions: Opioid Use Disorder

Treatments: Behavioral: Managing Physical Reactions to Overwhelming Emotions (IMPROVE); Behavioral: Health Education Training (HET)

Study type: Interventional

Funder types: Other

Identifiers

NCT06718491

2024H0358

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

80 participants in 2 patient groups

Managing Physical Reactions to Overwhelming Emotions (IMPROVE)

Experimental group

Description:

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

Treatment:

Behavioral: Managing Physical Reactions to Overwhelming Emotions (IMPROVE)

Health Education Training (HET)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Health Education Training (HET)