Can a Three-Session virtual therapy curb heavy drinking during opioid treatment?

NCT ID NCT06718491

Disease control Sponsor: Ohio State University Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This trial tests a short virtual therapy called IMPROVE, designed to help people on medication for opioid use disorder who also drink heavily. Participants attend three one-hour online sessions and use a mobile app to learn skills for managing emotional distress that can trigger alcohol use. The study compares IMPROVE to a health education control to see if it reduces heavy drinking days and improves medication adherence.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Managing Physical Reactions to Overwhelming Emotions (IMPROVE) – a brief virtual therapy with a mobile app
What this could lead to: If effective, this brief digital therapy could help people on opioid treatment reduce heavy drinking and stick with their medication, improving overall recovery.
What could go wrong: This is a small early-stage trial with only 80 participants, so results may not apply widely. The therapy is short (three sessions) and may not be enough for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

opiate dependence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Opioid use disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Can a Three-Session virtual therapy curb heavy drinking during opioid treatment?

What the study statuses mean