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NCT Number: NCT06718491

Brief Digitally-Enhanced Intervention for Reducing Alcohol Use During MOUD

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.

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Key information

Conditions

Opioid Use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University

Columbus, Ohio, 43210, United States

Location status: Recruiting

Location contact

Stephanie Gorka, PhD

CONTACT

[email protected]

614-366-1027

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Managing Physical Reactions to Overwhelming Emotions (IMPROVE)

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)

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.

Primary outcomes

  1. Alcohol Use

    Time frame: Change from baseline to post-treatment (week 4)

    Changes in proportion of heavy drinking days and drinks per drinking day following the intervention.

  2. Startle eyeblink potentiation during unpredictable threat

    Time frame: 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.

  3. Self-reported Intolerance of Uncertainty

    Time frame: 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.

  4. Late positive potential when viewing anxiety sensitivity evoking images

    Time frame: 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.

  5. Self-reported Anxiety Sensitivity

    Time frame: 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 outcomes

  1. Medication Adherence

    Time frame: Change from baseline to post-treatment (week 4)

    Changes in proportion of days compliant with medication for opioid use disorder.

  2. Distress-related alcohol use

    Time frame: Assessed multiple times a day for 21 days

    Participants will report their psychological distress and subsequent alcohol use behavior.

  3. Daily alcohol craving

    Time frame: Assessed multiple times a day for 21 days

    Participants will report their alcohol craving throughout each day.

Study contacts

Contact information is provided by the study sponsor or research team.

Stephanie Gorka, PhD

CONTACT

[email protected]

614-366-1027

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 5, 2024
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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