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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1307-0808 | Registry Identifier | WHO International Clinical Trials Registry Platform (ICTRP) |
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Sponsor decision
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 1356225 | Experimental |
| |
| Placebo matching BI 1356225 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1356225 | Drug | BI 1356225 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at baseline and at Day 8 |
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Inclusion Criteria:
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
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.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Collaborative Neuroscience Research, LLC, Los Alamitos | Los Alamitos | California | 90720 | United States | ||
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| Label | URL |
|---|---|
| Related Info | View source |
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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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One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
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| Drug |
Placebo |
|
| University of California Los Angeles |
| Los Angeles |
| California |
| 90095 |
| United States |
| iResearch Atlanta | Decatur | Georgia | 30030 | United States |
| Hassman Research Institute-Marlton-66897 | Marlton | New Jersey | 08053 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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