A Study to Test Whether BI 1356225 Improves Impulsive Behavior in Men With Opioid Use Disorder Who Are Taking Buprenorphine
- Registration Number
- NCT06628622
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
This study is open to men 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 men 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 60
- Male participants, 18 to 65 years of age, both inclusively, at the time of consent
- 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 6 months prior to screening
- Currently engaged in medications for opioid use disorder (MOUD) treatment at a buprenorphine/naloxone sublingual film total daily dose ranging from 8 mg/2 mg to 24 mg/6 mg or buprenorphine/naloxone sublingual tablet from 5.7 mg/1.4 mg to 17.1 mg/4.3 mg daily for at least 2 weeks at screening OR on a stable dose of depot injectable buprenorphine for at least 8 weeks at screening, with at least one week since last depot buprenorphine injection
- 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
- 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
- Further inclusion criteria apply
- 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
- 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)
- Severe stimulant use disorder within the 6 months prior to screening
- 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
- Score of ≥20 on the Montgomery-Åsberg Depression Rating Scale (MADRS).
- 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
- Any positive result on a urine drug screen (not counting buprenorphine and cannabis) at admission to the trial site on Day -1
- Intoxication at screening or randomization, as determined by clinical exam and breathalyzer
- Further exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BI 1356225 BI 1356225 - Placebo matching BI 1356225 Placebo -
- Primary Outcome Measures
Name Time Method Change from baseline in k parameter of the delay discounting task (DDT) at Day 8 at baseline and at Day 8 In the DDT, participants make choices on the screen between a smaller, immediate amount of money and a larger, delayed amount. Steep discounting of delayed rewards is indicative of cognitive impulsivity.
The key outcome variable for this task is the discount rate (k) or rate at which delayed rewards lose their value.Change from baseline in total number of premature responses in the 4-choice serial reaction time task (4-CSRTT) at Day 8 at baseline and at Day 8 The 4-CSRTT task is a computerized task of waiting impulsivity. Participants are required to press and hold down the space bar with their dominant index finger while four boxes are presented on the screen. After a specified period, a green circle target appears randomly in 1 of the 4 boxes. Participants are instructed to release the space bar and touch the box in which the target appeared.
The main outcome measure, premature responding, is defined as a release of the space bar before target onset.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
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