BI 1356225 for Opioid Use Disorder

Recruiting at 4 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: Boehringer Ingelheim

Must be taking: Buprenorphine

Disqualifiers: Schizophrenia, Bipolar, Severe stimulant use, others

Compensation: Varies

Number of Visits: 3

Duration: 8 days

60 Participants Needed

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.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications, specifically buprenorphine, which you will continue to take during the study.

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 have been diagnosed with moderate to severe opioid use disorder in the last 6 months.

I meet additional specific criteria for the study.

I am willing to avoid alcohol for 24 hours and drugs for 72 hours before the trial starts.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants take BI 1356225 or placebo tablets once a day for 8 days while continuing buprenorphine treatment. Impulsivity is tested using tasks or games on a computer and questionnaires.

8 days

3 visits (in-person), including a 9-night stay at the study site

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-3 weeks

Treatment Details

Interventions

• BI 1356225

Trial Overview 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.

Participant Groups

Group I: BI 1356225 Experimental Treatment 1 Intervention

Group II: Placebo matching BI 1356225 Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+