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A Study to Test Whether BI 1356225 Improves Impulsive Behavior in People With Opioid Use Disorder Who Are Taking Buprenorphine

Testing if BI 1356225 helps impulsivity in opioid users on Buprenorphine.

Recruiting
18-65 years
All
Phase 1

This study is for adults aged 18-65 who have an opioid use disorder, also known as opioid addiction. They must already be taking a medicine called buprenorphine. The study aims to see if a new medicine, BI 1356225, can help control impulsive behavior, which is when people act without thinking about the risks.

Participants are randomly placed into two groups: one takes BI 1356225, and the other takes a placebo, a pill that looks the same but has no medicine in it. They take one pill a day for 8 days and continue their regular buprenorphine treatment.

The study lasts up to 6 weeks and includes 3 visits to the study site. At one visit, participants stay for 9 nights. Doctors will check if the new medicine helps with impulsive behavior by using tasks on a computer and asking questions. They will also monitor for any side effects.

  • Participants stay at the study site for 9 nights during one visit.
  • The study lasts up to 6 weeks with 3 total visits.
  • Participants must continue taking buprenorphine throughout the study.
Study details
    Opioid Use Disorder

NCT06628622

Boehringer Ingelheim

7 March 2026

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