BI 1356225 for Opioid Use Disorder

Palo Alto (17 mi)

Age: 18+

Sex: Male

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Boehringer Ingelheim

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Men aged 18-65 with opioid use disorder who are currently on buprenorphine treatment can join this study. They must have been stable on their medication for at least two weeks, agree to avoid alcohol and drugs before starting the trial, and meet criteria for moderate or severe opioid addiction.

Inclusion Criteria

I am a man aged between 18 and 65.

I am currently on a stable dose of medication for opioid addiction.

Treatment Details

The study tests if BI 1356225 improves impulse control in men with opioid dependence. Participants are randomly assigned to take either BI 1356225 or a placebo daily for eight days while continuing buprenorphine. Their impulsivity is measured through computer tasks and questionnaires over six weeks.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: BI 1356225Experimental Treatment1 Intervention

Group II: Placebo matching BI 1356225Placebo Group1 Intervention