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NCT06441604

Extended-release Buprenorphine as a Novel Low-dose Induction Strategy

Active, Not Recruiting
PHASE2Ages 18+Interventional
Brigham and Women's Hospital
~8 participants
Updated 2026-07-09 on ClinicalTrials.gov
What's tested:Extended-release Buprenorphine

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and tolerability of XR-Buprenorphine
Measured over For the duration of the inpatient admission, lasting 24 hours after receipt of study drug.
+1 more outcome measured

Conditions

Opioid Use Disorder

Explore related trials

Opioid Use Disorder

Where it's being run

1 sites across 1 states
Massachusetts1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

English speaking adults aged 18 and above.
diagnosis of opioid use disorder.
Self-reporting use of illicit opioids in \>21 days in the prior 30 days.
Provide urine toxicology testing positive for fentanyl at baseline.

Exclusion

Seeking medication treatment for opioid use disorder with sublingual buprenorphine or methadone.
Received buprenorphine or methadone treatment in prior 30 days.
Current diagnosis of alcohol or sedative/hypnotic use disorder.
Positive urine drug screen for benzodiazepines, alcohol and or methadone.
Physical dependence on alcohol or sedative/hypnotics.
Psychotic disorder, active suicidality or homicidally or any psychiatric condition that impair ability to provide informed consent.
Have a history or diagnosis of Intracranial mass/bleed, seizure disorder, liver cirrhosis, renal failure, obstructive lung disease, hyperthyroidism, narrow-angle glaucoma, valvular heart disease, cardiac arrhythmias, heart failure.
Recent (within 6 months) head trauma, stroke, or myocardial infarction
Requiring treatment with opioids for acute or chronic pain.
History of hypersensitivity or allergy to buprenorphine or fentanyl.
Pregnant or breastfeeding.
Liver function test greater than 3 times upper normal limit.
Receiving medications that are strong or moderate CYP34A inducers or inhibitors (including but not limited to ketoconazole, itraconazole, clarithromycin, fluconazole, erythromycin), in the past 30 days.

What this trial measures

  • Safety and tolerability of XR-BuprenorphineFor the duration of the inpatient admission, lasting 24 hours after receipt of study drug.

    The primary outcome is the proportion of participants who successfully complete induction, defined as experiencing no BPOW, which will be assessed using the COWS. An increase in the COWS score by 8 or more with the total score exceeding 13, within 4 hours will be considered BPOW.

  • Plasma-concentration curves (AUC) of buprenorphine.Baseline, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours after study drug administration.

    The area under the plasma concentration curves (AUC) of buprenorphine will be determined. Timed blood samples will be collected in anticoagulant Vacutainer tubes via venipuncture at baseline, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours after the XR-BUP injection. Samples will be centrifuged and frozen until analysis.