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

Testing BI 1356225's effects on impulse control in men on buprenorphine.

Recruiting
18-65 years
Male
Phase 1
  • Simplified description (AI rewritten)
  • Technical description (Original)

This study is for men aged 18-65 who have *opioid use disorder*, a condition where people are addicted to opioids. Participants must already be taking a medicine called **buprenorphine**. The study aims to see if a new medicine called **BI 1356225** can help control impulsive behavior, which is acting without thinking and can lead to risky actions.

Participants will be randomly divided into two groups. One group will take BI 1356225 tablets, and the other group will take **placebo** tablets, which look the same but have no medicine. Everyone will take one tablet each day for 8 days while continuing their buprenorphine treatment.

The study lasts up to 6 weeks, with three visits to the study site. During the second visit, participants will stay for 9 nights. Doctors will test impulsivity using computer games and questionnaires to compare results between the two groups. Health checks and monitoring for any side effects are also part of the study.

  • Study duration is up to 6 weeks with 3 site visits.
  • Stay at the study site for 9 nights during the second visit.
  • Participation involves regular health checks and monitoring for side effects.
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Study details
    Opioid Use Disorder

NCT06628622

Boehringer Ingelheim

13 September 2025

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