Opioid Use DisorderNCT06718491
Brief Digitally-Enhanced Intervention for Reducing Alcohol Use During MOUD
A study testing Managing Physical Reactions to Overwhelming Emotions (IMPROVE) and Health Education Training (HET) in people with Opioid Use Disorder, run by Ohio State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Managing Physical Reactions to Overwhelming Emotions (IMPROVE) and Health Education Training (HET)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2025to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ohio State University
Columbus, Ohio, 43210
Stephanie Gorka, PhD, 614-366-1027, stephanie.gorka@osumc.edu
About this study
Official title: 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?
Read more
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
- Being tested
- Managing Physical Reactions to Overwhelming Emotions (IMPROVE), Health Education Training (HET)
- Keywords
- Medications for Opioid Use Disorder, Heavy Alcohol Use, Ecological Momentary Assessments, Electroencephalography
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Managing Physical Reactions to Overwhelming Emotions (IMPROVE)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Managing Physical Reactions to Overwhelming Emotions (IMPROVE) | Experimental | In this arm, participants will receive the IMPROVE intervention, a clinician-delivered protocol targeting anxiety and uncertainty. Receives: Behavioral: Managing Physical Reactions to Overwhelming Emotions (IMPROVE) |
| Health Education Training (HET) | Active comparator | 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. Receives: Behavioral: Health Education Training (HET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol Use
Changes in proportion of heavy drinking days and drinks per drinking day following the intervention.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline to post-treatment (week 4)
Secondary outcomes (3)
Medication Adherence
Changes in proportion of days compliant with medication for opioid use disorder.
Measured: Change from baseline to post-treatment (week 4)
Distress-related alcohol use
Participants will report their psychological distress and subsequent alcohol use behavior.
Measured: Assessed multiple times a day for 21 days
Daily alcohol craving
Participants will report their alcohol craving throughout each day.
Measured: Assessed multiple times a day for 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start1 Aug 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to receive one of two possible interventions.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie M Gorka, PhD, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06718491
- Sponsor's protocol ID
- 2024H0358
- Status last verified
- Jun 2026
- First submitted
- 2 Dec 2024
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Digitally-Enhanced Intervention for Managing Emotional Pain and Reducing Alcohol Use During Medication for OUD
- ClinicalTrials.gov ID
- NCT06718491
- Acronym / sponsor ID
- 2024H0358
- Conditions
- Opioid Use Disorder
- Keywords
- Medications for Opioid Use Disorder, Heavy Alcohol Use, Ecological Momentary Assessments, Electroencephalography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 5 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomized to receive one of two possible interventions.
| Arm | Type | Receives |
|---|---|---|
| Managing Physical Reactions to Overwhelming Emotions (IMPROVE) | Experimental | Behavioral: Managing Physical Reactions to Overwhelming Emotions (IMPROVE)In this arm, participants will receive the IMPROVE intervention, a clinician-delivered protocol targeting anxiety and uncertainty. |
| Health Education Training (HET) | Active comparator | Behavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Managing Physical Reactions to Overwhelming Emotions (IMPROVE) |
| 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. | Behavioural | Health Education Training (HET) |
Primary outcome
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.
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.
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.
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.
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.
3 secondary outcomes
Medication Adherence
Time frame: Change from baseline to post-treatment (week 4)
Distress-related alcohol use
Time frame: Assessed multiple times a day for 21 days
Daily alcohol craving
Time frame: Assessed multiple times a day for 21 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Managing Physical Reactions to Overwhelming Emotions (IMPROVE) and Health Education Training (HET) in people with Opioid Use Disorder, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Gorka, PhD (614-366-1027, stephanie.gorka@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol Use (time frame: Change from baseline to post-treatment (week 4)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.