Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06628622
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-04
Brief Title:
A Study to Test Whether BI 1356225 Improves Impulsive Behavior in Men With Opioid Use Disorder Who Are Taking Buprenorphine
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None