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

NCT06441604 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2024P001078
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a clinical trial to characterize the safety and pharmacokinetics of using extended-release buprenorphine (XR-BUP) as a novel low-dose buprenorphine induction strategy. Individuals with a diagnosis of Opioid Use Disorder (OUD) (n=30) will be admitted to an inpatient unit to complete study procedures over the course of 3 days. Participants will receive fentanyl to prevent the emergence of withdrawal. Each participant will then receive a single injection of XR-BUP after which study staff will monitor for any precipitated withdrawal.

Conditions

Opioid Use Disorder

Keywords

Opioid Use Disorder; Buprenorphine

Outcome Measures

Primary Outcomes (2)

• Safety and tolerability of XR-Buprenorphine

  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.

  For the duration of the inpatient admission, lasting 24 hours after receipt of study drug.

• Plasma-concentration curves (AUC) of buprenorphine.

  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.

  Baseline, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours after study drug administration.

Secondary Outcomes (5)

• Maximum Plasma Concentration

  Baseline, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours after study drug administration.

• Minimum Plasma Concentration (Cmin),

  Baseline, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours after study drug administration.

• Time to Maximum Plasma Concentration

  Baseline, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours after study drug administration.

• Elimination half-life

  Baseline, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours after study drug administration.

• Buccal Swab

  will be done once at the baseline visit.

Study Arms (3)

16mg Extended-Release Buprenorphine

EXPERIMENTAL

The first 10 participants will receive XR-BUP 16mg in single-blind fashion.

Drug: Extended-release Buprenorphine

24mg Buprenorphine

EXPERIMENTAL

After first 10 participants have been completed, the next 10 participants will receive 24mg in a single-blind fashion.

Drug: Extended-release Buprenorphine

32mg Buprenorphine

EXPERIMENTAL

After the 20 participants have been completed, the next 10 participants will receive 32mg in a single-blind fashion.

Drug: Extended-release Buprenorphine

Interventions

Extended-release Buprenorphine DRUG

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; 24mg Buprenorphine; 32mg Buprenorphine

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• University of Utah: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02118-5605, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Joji Suzuki

CONTACT

6177325752; jsuzuki2@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Only the participant will be masked.
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Division of Addiction Psychiatry

Model Details: 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.

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: June 4, 2024
• Study Start: October 27, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

US (1)