Opioid Use DisorderPhase 1NCT06628622
A Study to Test Whether BI 1356225 Improves Impulsive Behavior in People With Opioid Use Disorder Who Are Taking Buprenorphine
A Phase 1 study testing BI 1356225 in people with Opioid Use Disorder, run by Boehringer Ingelheim at 5 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- BI 1356225
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 5 sitesUnited States
- Study dates
- 27 Jan 2025to 16 Jul 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female 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 12 months prior to screening
- Currently engaged in medications for opioid use disorder (MOUD) treatment with one of the following regimens:
- 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
- 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
- buprenorphine sublingual tablet from 8 mg to 24 mg total daily dose for at least 2 weeks at screening OR
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- on depot injectable buprenorphine for at least 5 weeks at screening, with at least 1 week since last depot buprenorphine injection
- 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
- 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
- Women of child-bearing potential must be able and willing, as confirmed by the investigator, to use highly effective methods of contraception
- Further inclusion criteria apply.
Who cannot join
- 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 3 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 8 weeks 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 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
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- Any positive result on a urine drug screen (not counting buprenorphine, TCAs, or 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
iResearch Atlanta
Decatur, Georgia, 30030
Collaborative Neuroscience Research, LLC, Los Alamitos
Los Alamitos, California, 90720
University of California Los Angeles
Los Angeles, California, 90095
Hassman Research Institute-Marlton-66897
Marlton, New Jersey, 08053
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: 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 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
- Opioid Use Disorder
- Being tested
- BI 1356225, Placebo
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 1356225Drug
BI 1356225
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| BI 1356225 | Experimental | Not described Receives: Drug: BI 1356225 |
| Placebo matching BI 1356225 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in k parameter of the delay discounting task (DDT) on 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.
Measured: at baseline and at Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start27 Jan 2025
- Primary completion27 Mar 2026
- Study completion16 Jul 2026
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06628622
- Sponsor's protocol ID
- 1427-0015
- Other IDs
- U1111-1307-0808
- Status last verified
- Jul 2026
- First submitted
- 4 Oct 2024
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once the criteria in section 'time frame' are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06628622
- Acronym / sponsor ID
- 1427-0015
- Conditions
- Opioid Use Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- 27 Mar 2026 (actual)
- Study completion
- 16 Jul 2026 (actual)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BI 1356225 | Experimental | Drug: BI 1356225 |
| Placebo matching BI 1356225 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male and female 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 12 months prior to screening
- Currently engaged in medications for opioid use disorder (MOUD) treatment with one of the following regimens:
- 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
- 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
Key exclusion criteria (9 listed)
- 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 3 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 8 weeks prior to randomization
- Score of ≥20 on the Montgomery-Åsberg Depression Rating Scale (MADRS)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI 1356225BI 1356225 | Drug | BI 1356225 |
| PlaceboPlacebo | Drug | Placebo matching BI 1356225 |
Primary outcome
Change from baseline in k parameter of the delay discounting task (DDT) on Day 8
Time frame: 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.
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Once the criteria in section 'time frame' are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 1356225 in people with Opioid Use Disorder, run by Boehringer Ingelheim at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in k parameter of the delay discounting task (DDT) on Day 8 (time frame: at baseline and at Day 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.