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NCT06628622 · ClinicalTrials.gov registry record · Phase 1
A Study to Test Whether BI 1356225 Improves Impulsive Behavior in People With Opioid Use Disorder Who Are Taking Buprenorphine
A Phase 1 study of Opioid Use Disorder, sponsored by Boehringer Ingelheim.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 5
- Study locations
NCT06628622: Recruiting Phase 1 study of Opioid Use Disorder, sponsored by Boehringer Ingelheim.
NCT06628622 is a Phase 1 study of Opioid Use Disorder that is actively recruiting participants, run by Boehringer Ingelheim. The registered enrollment target is 60 participants, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (99% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06628622, a Phase 1 study of Opioid Use Disorder, is actively recruiting participants, sponsored by Boehringer Ingelheim.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 5
- Study locations
Study Summary
This study is open to people between 18 and 65 years of age with opioid use disorder. Opioid use disorder is also called opioid addiction or opioid dependence. People can join the study if they currently take a medicine called buprenorphine. People with opioid dependence can act on impulse, which can lead to risky behaviours. The purpose of this study is to find out whether a medicine called BI 1356225 improves impulse control in people with opioid dependence. Participants are put into 2 groups by chance. One group takes BI 1356225 tablets and the other group takes placebo tablets. Placebo tablets look like BI 1356225 tablets but do not contain any medicine. Participants take a tablet once a day for 8 days. All participants also continue taking buprenorphine. Participants are in the study for up to 6 weeks. During this time, they visit the study site 3 times. At visit 2, participants stay at the study site for 9 nights. Doctors test participants' impulsivity using tasks or games on a computer and questionnaires. The results are compared between the 2 groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.
Primary Outcome
In the DDT, participants make choices on the screen between a smaller, immediate amount of money and a larger, delayed amount. Steep discounting of delayed rewards is indicative of cognitive impulsivity. The key outcome variable for this task is the discount rate (k) or rate at which delayed rewards lose their value.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG BI 1356225
Study Locations (5)
California
- Collaborative Neuroscience Research, LLC, Los Alamitos - Los Alamitos
- University of California Los Angeles - Los Angeles
Georgia
- iResearch Atlanta - Decatur
New Jersey
- Hassman Research Institute-Marlton-66897 - Marlton
Virginia
- Virginia Commonwealth University - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-01-27 |
| Est. Completion | 2027-02-14 |
| Phase | Phase 1 |
What NCT06628622 shows while recruiting
NCT06628622 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Opioid Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06628622 lists 5 locations in 4 states (California, Georgia, New Jersey).
Frequently Asked Questions
What is clinical trial NCT06628622 about?
NCT06628622 is a clinical study titled "A Study to Test Whether BI 1356225 Improves Impulsive Behavior in People With Opioid Use Disorder Who Are Taking Buprenorphine". This study is open to people between 18 and 65 years of age with opioid use disorder. Opioid use disorder is also called opioid addiction or opioid dependence. People can join the study if they currently take a medicine called buprenorphine. People with opioid dependence can act on impulse, which ca...
What is the current status of trial NCT06628622?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2025-01-27. Estimated completion is 2027-02-14.
What conditions does trial NCT06628622 study?
This clinical trial studies the following conditions: Opioid Use Disorder.
What interventions are being tested in trial NCT06628622?
The interventions under investigation include: Placebo (DRUG), BI 1356225 (DRUG).
Who is sponsoring clinical trial NCT06628622?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06628622 being conducted?
This trial has 5 study locations across California, Georgia, New Jersey, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06628622's enrollment target sits among peer trials
60 156th of 257 higher than 91 of 257 other Opioid Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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