Brigham Research Institute (BRI) - Brigham and Women's Hospital

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

Purpose

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.

Condition

Opioid Use Disorder

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

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 Criteria

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.

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: 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.
Primary Purpose: Other
Masking: Single (Participant)
Masking Description: Only the participant will be masked.

Arm Groups

Arm	Description	Assigned Intervention
Experimental 16mg Extended-Release Buprenorphine	The first 10 participants will receive XR-BUP 16mg in single-blind fashion.	Drug: 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.
Experimental 24mg Buprenorphine	After first 10 participants have been completed, the next 10 participants will receive 24mg in a single-blind fashion.	Drug: 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.
Experimental 32mg Buprenorphine	After the 20 participants have been completed, the next 10 participants will receive 32mg in a single-blind fashion.	Drug: 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.

Recruiting Locations

Brigham and Women's Hospital
Boston 4930956, Massachusetts 6254926 02118-5605

Contact:
Anika Clinical Research Coordinator
617-525-0676
akopczynski@bwh.harvard.edu

More Details

Status: Recruiting
Sponsor: Brigham and Women's Hospital

Study Contact

Joji Suzuki
6177325752
jsuzuki2@bwh.harvard.edu

Detailed Description

The approach is to conduct a single ascending dose trial in a controlled human laboratory setting with individuals with a diagnosis of OUD (n=30) actively using illicit fentanyl. After obtaining informed consent and establishing eligibility, 10 participants will be scheduled for an inpatient visit lasting 3 days, 2 nights and receive XR-BUP when not yet experiencing any opioid withdrawal. Participants will receive fentanyl to prevent the emergence of withdrawal, and on the following morning, receive XR-BUP 16mg in single-blind fashion. If at least 90% successfully complete induction (success defined as experiencing no precipitated withdrawal) with the 16mg dose, then we will proceed with 10 more participants to receive the 24mg dose. If at least 90% successfully complete induction the 24mg dose, then we will proceed with 10 more participants to the 32mg dose. Timed blood samples will be collected in heparinized Vacutainer tubes via a catheter in the antecubital vein at baseline, and at 0.5, 1, 2, 4, 6, 8, 12, and 24 hours after the XR-BUP injection.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.