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NCT06628622 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Opioid Use Disorder, sponsored by Boehringer Ingelheim.

Recruiting
Registry status
Phase 1
Development phase
60
Enrollment target
5
Study locations

NCT06628622 is a Phase 1 study of Opioid Use Disorder that is actively recruiting participants, run by Boehringer Ingelheim. The registered enrollment target is 60 participants, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (99% lower). The trial reports 5 study locations across 4 states.

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The verdict

NCT06628622, a Phase 1 study of Opioid Use Disorder, is actively recruiting participants, sponsored by Boehringer Ingelheim.

RECRUITING
Registry status
Phase 1
Development phase
60 participants
Enrollment target
5
Study locations

Study 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 Studied

Opioid Use Disorder

Interventions

  • DRUG Placebo
  • DRUG BI 1356225

Study Locations (5)

California

  • Collaborative Neuroscience Research, LLC, Los Alamitos - Los Alamitos
  • University of California Los Angeles - Los Angeles

Georgia

  • iResearch Atlanta - Decatur

New Jersey

  • Hassman Research Institute-Marlton-66897 - Marlton

Virginia

  • Virginia Commonwealth University - Richmond

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2025-01-27
Est. Completion 2027-02-14
Phase Phase 1

Sponsor

Boehringer Ingelheim

515 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06628622

The ClinicalTrials.gov registry entry for NCT06628622 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (99% lower). The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Opioid Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT06628622 reports 5 study locations spanning 4 distinct geographic areas - top geographies include California, Georgia, New Jersey.

Frequently Asked Questions

What is clinical trial NCT06628622 about?

NCT06628622 is a clinical study titled "A Study to Test Whether BI 1356225 Improves Impulsive Behavior in People With Opioid Use Disorder Who Are Taking Buprenorphine". 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 ca...

What is the current status of trial NCT06628622?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2025-01-27. Estimated completion is 2027-02-14.

What conditions does trial NCT06628622 study?

This clinical trial studies the following conditions: Opioid Use Disorder.

What interventions are being tested in trial NCT06628622?

The interventions under investigation include: Placebo (DRUG), BI 1356225 (DRUG).

Who is sponsoring clinical trial NCT06628622?

This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06628622 being conducted?

This trial has 5 study locations across California, Georgia, New Jersey, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.