A Study to Test Whether BI 1356225 Improves Impulsive Behavior in People With Opioid Use Disorder Who Are Taking Buprenorphine
NCT ID: NCT06628622
Last Updated: 2026-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
60 participants
INTERVENTIONAL
2025-01-27
2027-02-14
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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BI 1356225
BI 1356225
BI 1356225
Placebo matching BI 1356225
Placebo
Placebo
Interventions
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BI 1356225
BI 1356225
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
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 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. Women of child-bearing potential must be able and willing, as confirmed by the investigator, to use highly effective methods of contraception
Exclusion Criteria
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)
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
18 Years
65 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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Collaborative Neuroscience Research, LLC, Los Alamitos
Los Alamitos, California, United States
University of California Los Angeles
Los Angeles, California, United States
iResearch Atlanta
Decatur, Georgia, United States
Hassman Research Institute-Marlton-66897
Marlton, New Jersey, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Related Info
Other Identifiers
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U1111-1307-0808
Identifier Type: REGISTRY
Identifier Source: secondary_id
1427-0015
Identifier Type: -
Identifier Source: org_study_id
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