Testing BI 1356225 for Impulsive Behavior in Men with Opioid Use Disorder

A Phase Ib, Multi-center, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial to Evaluate the Effects on Impulsivity, Pharmacokinetics, Safety, and Tolerability of Oral BI 1356225 in Patients With Opioid Use Disorder Taking Background Buprenorphine Treatment

This study is testing if a new medication called BI 1356225 can help men with opioid use disorder control their impulsive behavior while they are on buprenorphine.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Boehringer Ingelheim (Industry-sponsored)
• Locations: 5 sites (Los Alamitos, California and 4 other locations)
• Trial ID: NCT06628622 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of BI 1356225 on impulsive behavior in men aged 18 to 65 who have opioid use disorder and are currently taking buprenorphine. Participants are randomly assigned to receive either BI 1356225 or a placebo for 8 days while continuing their buprenorphine treatment. The study aims to assess whether the medication can improve impulse control through various tasks and games designed to measure impulsivity. Participants will be monitored over a period of up to 6 weeks with multiple site visits.

Who should consider this trial

Good fit: Ideal candidates are men aged 18 to 65 who have a moderate to severe opioid use disorder and are currently on a stable dose of buprenorphine.

Not a fit: Patients who are not male, outside the age range, or not currently engaged in buprenorphine treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve impulse control in men with opioid use disorder, potentially reducing risky behaviors associated with the condition.

How similar studies have performed: While there have been studies on opioid use disorder treatments, the specific approach of using BI 1356225 for impulsivity is novel and has not been extensively tested.

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 inclusion criterion 3 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. Women of child-bearing potential must be able and willing, as confirmed by the investigator, to use highly effective methods of contraception
7. 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 3 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 8 weeks 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 or TCAs) 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, TCAs, or 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.

Where this trial is running

Los Alamitos, California and 4 other locations

• Collaborative Neuroscience Research, LLC, Los Alamitos — Los Alamitos, California, United States (Recruiting)
• University of California Los Angeles — Los Angeles, California, United States (Recruiting)
• iResearch Atlanta — Decatur, Georgia, United States (Recruiting)
• Hassman Research Institute-Marlton-66897 — Marlton, New Jersey, United States (Recruiting)
• Virginia Commonwealth University — Richmond, Virginia, United States (Recruiting)

Study contacts

• Study coordinator: Boehringer Ingelheim

Conditions Opioid Use Disorder