Actively Recruiting
A Study to Test Whether BI 1356225 Improves Impulsive Behavior in People With Opioid Use Disorder Who Are Taking Buprenorphine
Led by Boehringer Ingelheim · Updated on 2026-03-04
60
Participants Needed
5
Research Sites
106 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is open to people between 18 and 65 years of age with opioid use disorder. Opioid use disorder is also called opioid addiction or opioid dependence. People can join the study if they currently take a medicine called buprenorphine. People with opioid dependence can act on impulse, which can lead to risky behaviours. The purpose of this study is to find out whether a medicine called BI 1356225 improves impulse control in people with opioid dependence. 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.
CONDITIONS
Official Title
A Study to Test Whether BI 1356225 Improves Impulsive Behavior in People With Opioid Use Disorder Who Are Taking Buprenorphine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female participants aged 18 to 65 years at consent
- Diagnosis of opioid use disorder of at least moderate severity within 12 months prior to screening
- Currently receiving medication for opioid use disorder including specified buprenorphine/naloxone or buprenorphine regimens for at least 2 weeks or depot injectable buprenorphine for at least 5 weeks
- Positive urine drug screen for buprenorphine at screening and randomization
- Willingness to abstain from alcohol for 24 hours and other drugs of abuse for 72 hours before Day 1 through Day 9 discharge
- Women of child-bearing potential must agree to use highly effective contraception
- Additional inclusion criteria apply
You will not qualify if you...
- Lifetime diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar I disorder, delusional disorder, or autism spectrum disorder
- Moderate or severe substance use disorder other than opioid use disorder within 6 months prior to screening (excluding tobacco, caffeine, and moderate stimulant use)
- Severe stimulant use disorder within 3 months prior to screening
- Any unstable psychiatric disorder with symptom or treatment changes within 8 weeks prior to randomization
- Montgomery-5sberg Depression Rating Scale score 20
- Positive urine drug screen for 3 or more drugs (excluding buprenorphine or TCAs) at screening
- Positive urine drug screen (excluding buprenorphine, TCAs, or cannabis) at admission on Day -1
- Intoxication at screening or randomization as determined by clinical exam and breathalyzer
- Additional exclusion criteria apply
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
Collaborative Neuroscience Research, LLC, Los Alamitos
Los Alamitos, California, United States, 90720
Actively Recruiting
2
University of California Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
3
iResearch Atlanta
Decatur, Georgia, United States, 30030
Actively Recruiting
4
Hassman Research Institute-Marlton-66897
Marlton, New Jersey, United States, 08053
Actively Recruiting
5
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Actively Recruiting
Research Team
B
Boehringer Ingelheim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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