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

Launched by BOEHRINGER INGELHEIM · Oct 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medicine called BI 1356225 to see if it helps improve impulsive behavior in men aged 18 to 65 who have opioid use disorder and are currently taking buprenorphine. Opioid use disorder, also known as opioid addiction, can make people act on impulse, leading to risky behaviors. The trial will involve two groups of participants: one group will receive BI 1356225 tablets, while the other will receive a placebo (a tablet with no active medicine). Participants will take the tablets once a day for 8 days while continuing their buprenorphine treatment.

To participate, men must meet certain criteria, such as being diagnosed with opioid use disorder, being stable on their buprenorphine treatment, and not having serious psychiatric disorders. Throughout the study, participants will visit the study site three times, including a stay of 9 nights for testing. They will complete tasks on a computer to measure their impulsivity and fill out questionnaires. Doctors will also monitor their health and any side effects. This trial is an important step in finding new ways to help people manage their impulsive behaviors related to opioid use disorder.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Male 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 a stable dose of 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 inclusion criterion 4 and a positive urine drug screen for buprenorphine during screening and upon presenting for randomization to document buprenorphine use
• • 5. Willingness to abstain from using alcohol for 24 hours (h) and all other drugs of abuse for 72 h prior to Day 1 and through discharge from the trial site on Day 9
• • 6. Further inclusion criteria apply
• Exclusion Criteria:
• • 1. Lifetime diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar I disorder, delusional disorder, or autism spectrum disorder as confirmed by the mini international neuropsychiatric interview (MINI) at the screening visit
• • 2. Moderate or severe substance use disorder other than opioid use disorder (OUD) within the 6 months prior to screening (excluding tobacco, caffeine, and moderate stimulant use)
• • 3. Severe stimulant use disorder within the 6 months prior to screening
• • 4. Any other psychiatric disorder that is not currently stable in symptoms and treatment. Stable is defined as having no significant changes in symptom acuity or treatment (medication or psychotherapy treatment) in the 3 months prior to randomization
• • 5. Score of ≥20 on the Montgomery-Åsberg Depression Rating Scale (MADRS).
• • 6. Positive results on a urine drug screen for ≥3 drugs (not counting buprenorphine) at screening. In the case of a positive drug screen for 1 or 2 agents, if the participant does not meet the exclusion criteria regarding substance use disorder for these compounds, they may be included if the investigator determines that use will not be an impediment to trial participation or accurate data collection
• • 7. Any positive result on a urine drug screen (not counting buprenorphine and cannabis) at admission to the trial site on Day -1
• • 8. Intoxication at screening or randomization, as determined by clinical exam and breathalyzer
• • 9. Further exclusion criteria apply