Recruiting

Digitally-Enhanced Intervention

Sponsor:

Ohio State University

Code:

NCT06718491

Conditions

Opioid Use Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Managing Physical Reactions to Overwhelming Emotions (IMPROVE)

Health Education Training (HET)

Study Details

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 ID

NCT06718491

Start date

Aug 1, 2025

Status verified date

Jun, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

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.

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.

Primary outcome measure

  • Alcohol Use [ Time Frame: Change from baseline to post-treatment (week 4) ]
  • Startle eyeblink potentiation during unpredictable threat [ Time Frame: Change from baseline to post-treatment (week 4) ]
  • Self-reported Intolerance of Uncertainty [ Time Frame: Change from baseline to post-treatment (week 4) ]
  • Late positive potential when viewing anxiety sensitivity evoking images [ Time Frame: Change from baseline to post-treatment (week 4) ]
  • Self-reported Anxiety Sensitivity [ Time Frame: Change from baseline to post-treatment (week 4) ]

Central Contacts and Locations

Central contacts

Stephanie Gorka, PhD

614-366-1027stephanie.gorka@osumc.edu

Locations

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Stephanie Gorka, PhD

614-366-1027stephanie.gorka@osumc.edu

More Information

Sponsor

Ohio State University

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Keywords

  • Medications for Opioid Use Disorder
  • Heavy Alcohol Use
  • Ecological Momentary Assessments
  • Electroencephalography

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-06-22.