NCT06628622 is a Phase 1 clinical trial of BI 1356225 in Opioid Use Disorder, sponsored by Boehringer Ingelheim.

Who is sponsoring NCT06628622?

NCT06628622 is sponsored by Boehringer Ingelheim.

What drugs are being tested in NCT06628622?

Interventions in NCT06628622: BI 1356225, Placebo.

What condition does NCT06628622 study?

NCT06628622 studies Opioid Use Disorder.

Is NCT06628622 still recruiting?

NCT06628622 is currently recruiting now. Last updated 4 March 2026.

Last reviewed 2026-03-04 · How we verify

NCT06628622

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Recruiting now Phase 1 Last updated 4 March 2026

What this trial tests

Phase 1 trial testing BI 1356225 in Opioid Use Disorder in 60 participants. Currently enrolling.

Timeline

27 January 2025

Primary endpoint
4 February 2027

14 February 2027

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	60
Start date	27 January 2025
Primary completion	4 February 2027
Estimated completion	14 February 2027
Sites	5 locations across United States

Drugs / interventions tested

BI 1356225 — full drug profile →
Placebo

Conditions studied

Opioid Use Disorder — all drugs for Opioid Use Disorder →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

Adults 18 to 65, any sex, with Opioid Use Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of BI 1356225

Trials testing the same drug.

NCT04447261 — A Study to Test How Well Different Doses of BI 1356225 Are Tolerated by Men and Women With Obesity or Overweight · Phase 1 · completed
NCT04065295 — A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 · Phase 1 · completed

Other recruiting trials for Opioid Use Disorder

Currently open trials in the same condition.

NCT07278518 — Evaluation of a Patient Decision Aid for Emergency Department Initiated Buprenorphine · NA · recruiting
NCT07044466 — Social Functioning in Opioid Use Disorder · NA · recruiting
NCT07158853 — Combined tDCS and Cognitive Training as an Adjunctive Treatment in Opioid Use Disorder · NA · recruiting
NCT06943859 — Ketamine for Opioid Use Disorder · Phase 2 · recruiting
NCT06651177 — Evaluation of Tirzepatide as an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder · Phase 2 · recruiting

Other Boehringer Ingelheim trials

Trials by the same sponsor.

NCT07044700 — Real-world Comparative Effectiveness and Safety of Jardiance in Chinese Patients With Heart Failure of Reduced Ejection · not yet recruiting
NCT07047508 — Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure a · not yet recruiting
NCT07366034 — A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With I · Phase 3 · not yet recruiting
NCT07531628 — A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants · Phase 1 · not yet recruiting
NCT07497087 — A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis · Phase 3 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06628622 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 4 March 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06628622.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing