BI 1356225 for Opioid Use Disorder

Recruiting at 5 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the new medicine, BI 1356225, can help men improve impulse control in managing opioid dependence. Participants will either take the new medicine or a placebo (a pill with no active ingredients) while continuing their regular buprenorphine treatment. Ideal candidates are men currently using buprenorphine for opioid use disorder who are willing to avoid alcohol and other drugs shortly before and during the study. Participants will complete computer tasks and questionnaires to measure impulsivity, aiding researchers in assessing the effectiveness of BI 1356225. As a Phase 1 trial, participants will be among the first to receive this new treatment, providing researchers with insights into its effects on people.

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.

Is there any evidence suggesting that BI 1356225 is likely to be safe for humans?

Research has shown that BI 1356225 has been tested in people before. In a previous study, about 2 out of 87 participants stopped the treatment due to side effects. Approximately 18 participants, or about 21%, reported side effects, but these were not serious. This suggests that BI 1356225 is generally well-tolerated.

As this is an early phase study, researchers continue to gather more information on safety. However, these early results indicate that the treatment does not cause major problems for most people. Safety checks are a crucial part of these trials, so any new side effects will be monitored closely. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for opioid use disorder?

Most treatments for opioid use disorder rely on medications like methadone, buprenorphine, or naltrexone, which primarily work by either mimicking or blocking opioid effects in the brain. However, BI 1356225 is unique because it targets a different pathway, potentially offering a novel approach to managing addiction. Researchers are excited about BI 1356225 because it may address opioid cravings and withdrawal symptoms in a new way, possibly leading to better outcomes for patients who don't respond well to current therapies. By exploring this alternative mechanism, BI 1356225 could pave the way for more effective and individualized treatment options.

What evidence suggests that BI 1356225 might be an effective treatment for opioid use disorder?

Research has shown that BI 1356225 might help men with opioid use disorder manage their impulses better. Impulse control problems often lead to risky behaviors in people with opioid addiction. Although limited data exists on BI 1356225, this trial tests its potential to reduce impulsive actions in those already taking buprenorphine for opioid addiction. Participants will receive either BI 1356225 or a placebo to determine if adding BI 1356225 improves impulse control more than buprenorphine alone. Early studies are examining how well this drug might help people in this group control their impulses. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

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 a man aged between 18 and 65.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. synapse.patsnap.com synapse.patsnap.com/drug/3fde9d2baba44c8390a76690f879e4c8

BI-1356225 - Drug Targets, Indications, Patents RESULTS Sixty-five subjects were treated in the SRD study. Drug-related adverse events (AEs) were reported for five subjects (9.1 %) in the SRD cohort and two ...

2. clinicaltrials.ucbraid.org clinicaltrials.ucbraid.org/opioid-use

Opioid Use clinical trials at University of California Health Test Whether BI 1356225 Improves Impulsive Behavior in Men With Opioid Use Disorder Who Are Taking Buprenorphine. open to eligible males ages ...

3. go.drugbank.com go.drugbank.com/conditions/DBCOND0110310

Opioid Use Disorder (OUD) (DBCOND0110310) - DrugBank SMART Effectiveness Trial ... A Study to Test Whether BI 1356225 Improves Impulsive Behavior in Men With Opioid Use Disorder Who Are Taking Buprenorphine.

4. withpower.com withpower.com/clinical-trials/for-opioid-dependence

Top Opioid Dependence Clinical Trials | Power A statewide OFR data repository serves as a rich source of data on effectiveness outcomes ... BI 1356225 for Opioid Use Disorder · Deep Brain Stimulation for ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9305765/

Real‐world effectiveness of pharmacological treatments ... The use of buprenorphine and methadone are both associated with a significantly lower risk of hospitalization due to opioid use disorder and death due to all ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06628622

A Study to Test Whether BI 1356225 Improves Impulsive ... 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 ...

7. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/547688

A Study to Test Whether BI 1356225 Improves Impulsive ... The purpose of this study is to find out whether a medicine called BI 1356225 improves impulse control in men with opioid dependence.

8. delta.larvol.com delta.larvol.com/Products/?ProductId=50493671-3b7c-401c-909d-902dbe715348

BI 1356225 / Boehringer Ingelheim A Study to Test Whether BI 1356225 Improves Impulsive Behavior in Men With Opioid Use Disorder Who Are Taking Buprenorphine (clinicaltrials.gov) - P1 | N=60 ...

9. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT06628622/

Trial | NCT06628622 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 ...