NCT06628622 A Study to Test Whether BI 1356225 Improves Impulsive Behavior in People With Opioid Use Disorder Who Are Taking Buprenorphine
| NCT ID | NCT06628622 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Boehringer Ingelheim |
| Condition | Opioid Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-01-27 |
| Primary Completion | 2027-02-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2025-01-27 with a primary completion date of 2027-02-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Male and female participants, 18 to 65 years of age, both inclusively, at the time of consent 2. Meet current diagnostic and statistical manual of mental disorders, fifth edition (DSM-5) criteria for opioid use disorder, of at least moderate severity within the 12 months prior to screening 3. Currently engaged in medications for opioid use disorder (MOUD) treatment with one of the following regimens: 1. buprenorphine/naloxone sublingual film total daily dose ranging from 8 mg/2 mg to 24 mg/6 mg for at least 2 weeks at screening OR 2. buprenorphine/naloxone sublingual tablet from 5.7 mg/1.4 mg to 17.1 mg/4.3 mg total daily dose for at least 2 weeks at screening OR 3. buprenorphine sublingual tablet from 8 mg to 24 mg total daily dose for at least 2 weeks at screening OR 4. on depot injectable buprenorphine for at least 5 weeks at screening, with at least 1 week since last depot buprenorphine injection 4. Have a current MOUD prescription in accordance with inclusio
Frequently Asked Questions
Who can join the NCT06628622 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Opioid Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06628622 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06628622 currently recruiting?
Yes, NCT06628622 is actively recruiting participants. Visit ClinicalTrials.gov or contact Boehringer Ingelheim to inquire about joining.
Where is the NCT06628622 trial being conducted?
This trial is being conducted at Los Alamitos, United States, Los Angeles, United States, Decatur, United States, Marlton, United States and 1 additional location.
Who is sponsoring the NCT06628622 clinical trial?
NCT06628622 is sponsored by Boehringer Ingelheim. The trial plans to enroll 60 participants.