Clinical trial for Opioid Use Disorder
Official title Brief Digitally-Enhanced Intervention for Reducing Alcohol Use During MOUD
ClinicalTrials.gov ID: NCT06718491
What this study is testing
- What it's testing
- The study wants to see if a brief online therapy called IMPROVE can lower daily alcohol use and improve adherence to opioid medication, and whether it changes how people feel about uncertainty and anxiety.
- Who it's for
- It is looking for adults who are receiving medication for opioid use disorder and who drink heavily.
- What's involved
- Participants will do a baseline brain scan and questionnaires, then have three one‑hour online therapy sessions (or a health‑education control) spaced a week apart, followed by a post‑therapy brain scan and questionnaires. They will also answer short surveys on their phone five times a day for 21 days and complete questionnaires one month after the last session.
- Time commitment
- The study lasts about three weeks of weekly sessions plus a month of follow‑up, with several short visits and daily phone surveys.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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
You likely can't join if
- 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...
- 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)
See the full eligibility 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Columbus, Ohio, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.