A Study to Test Whether BI 1356225 Improves Impulsive Behavior in People With Opioid Use Disorder Who Are Taking Buprenorphine

NCT06628622 | Suspended Phase 1 FDA Drug

• 2 other identifiers: 1427-0015U1111-1307-0808
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Opioid Use Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

BI 1356225

EXPERIMENTAL

Drug: BI 1356225

Placebo matching BI 1356225

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Placebo DRUG

Placebo

Placebo matching BI 1356225

BI 1356225 DRUG

BI 1356225

BI 1356225

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• buprenorphine/naloxone sublingual film total daily dose ranging from 8 mg/2 mg to 24 mg/6 mg for at least 2 weeks at screening OR
• buprenorphine/naloxone sublingual tablet from 5.7 mg/1.4 mg to 17.1 mg/4.3 mg total daily dose for at least 2 weeks at screening OR
• buprenorphine sublingual tablet from 8 mg to 24 mg total daily dose for at least 2 weeks at screening OR
• on depot injectable buprenorphine for at least 5 weeks at screening, with at least 1 week since last depot buprenorphine injection
• 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

You may not qualify if:

• Lifetime diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar I disorder, delusional disorder, or autism spectrum disorder as confirmed by the mini international neuropsychiatric interview (MINI) at the screening visit
• Moderate or severe substance use disorder other than opioid use disorder (OUD) within the 6 months prior to screening (excluding tobacco, caffeine, and moderate stimulant use)
• Severe stimulant use disorder within the 3 months prior to screening
• Any other psychiatric disorder that is not currently stable in symptoms and treatment. Stable is defined as having no significant changes in symptom acuity or treatment (medication or psychotherapy treatment) in the 8 weeks prior to randomization
• Score of ≥20 on the Montgomery-Åsberg Depression Rating Scale (MADRS)
• Any positive result on a urine drug screen (not counting buprenorphine, TCAs, or cannabis) at admission to the trial site on Day -1
• Intoxication at screening or randomization, as determined by clinical exam and breathalyzer

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (5)

Collaborative Neuroscience Research, LLC, Los Alamitos

Los Alamitos, California, 90720, United States

Location

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

iResearch Atlanta

Decatur, Georgia, 30030, United States

Location

Hassman Research Institute-Marlton-66897

Marlton, New Jersey, 08053, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 8, 2024
• Study Start: January 27, 2025
• Primary Completion (Estimated): February 4, 2027
• Study Completion (Estimated): February 14, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: 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.
• Access Criteria: 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.

Locations

US (5)