Extended-release Buprenorphine as a Novel Low-dose Induction Strategy
NCT ID: NCT06441604
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
30 participants
INTERVENTIONAL
2025-10-27
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
OTHER
SINGLE
Study Groups
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32mg Buprenorphine
After the 20 participants have been completed, the next 10 participants will receive 32mg in a single-blind fashion.
Extended-release Buprenorphine
The study is a single-blind, fixed-order, dose-escalation designed trial in an inpatient setting with individuals with a DSM-5 diagnosis of OUD (n=30). The first 10 participants will receive XR-BUP 16mg in single-blind fashion. We will then proceed with 10 more participants to the 24mg dose, and finally proceed with 10 more participants to the 32mg dose. All participants will receive fentanyl to prevent withdrawal symptoms. (Figure 2). Symptomatic treatments will be provided at any sign of worsening withdrawal including evidence of precipitated withdrawal.
16mg Extended-Release Buprenorphine
The first 10 participants will receive XR-BUP 16mg in single-blind fashion.
Extended-release Buprenorphine
The study is a single-blind, fixed-order, dose-escalation designed trial in an inpatient setting with individuals with a DSM-5 diagnosis of OUD (n=30). The first 10 participants will receive XR-BUP 16mg in single-blind fashion. We will then proceed with 10 more participants to the 24mg dose, and finally proceed with 10 more participants to the 32mg dose. All participants will receive fentanyl to prevent withdrawal symptoms. (Figure 2). Symptomatic treatments will be provided at any sign of worsening withdrawal including evidence of precipitated withdrawal.
24mg Buprenorphine
After first 10 participants have been completed, the next 10 participants will receive 24mg in a single-blind fashion.
Extended-release Buprenorphine
The study is a single-blind, fixed-order, dose-escalation designed trial in an inpatient setting with individuals with a DSM-5 diagnosis of OUD (n=30). The first 10 participants will receive XR-BUP 16mg in single-blind fashion. We will then proceed with 10 more participants to the 24mg dose, and finally proceed with 10 more participants to the 32mg dose. All participants will receive fentanyl to prevent withdrawal symptoms. (Figure 2). Symptomatic treatments will be provided at any sign of worsening withdrawal including evidence of precipitated withdrawal.
Interventions
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Extended-release Buprenorphine
The study is a single-blind, fixed-order, dose-escalation designed trial in an inpatient setting with individuals with a DSM-5 diagnosis of OUD (n=30). The first 10 participants will receive XR-BUP 16mg in single-blind fashion. We will then proceed with 10 more participants to the 24mg dose, and finally proceed with 10 more participants to the 32mg dose. All participants will receive fentanyl to prevent withdrawal symptoms. (Figure 2). Symptomatic treatments will be provided at any sign of worsening withdrawal including evidence of precipitated withdrawal.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
ALL
No
Sponsors
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University of Utah
OTHER
Brigham and Women's Hospital
OTHER
Responsible Party
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Joji Suzuki, MD
Director, Division of Addiction Psychiatry
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Anika Clinical Research Coordinator
Role: primary
Other Identifiers
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2024P001078
Identifier Type: -
Identifier Source: org_study_id