Clinical trial NCT06441604: Extended-release Buprenorphine as a Novel Low-dose Induction Strategy
Official title: Extended-release Buprenorphine as a Novel Low-dose Induction Strategy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Opioid Use Disorder
Keywords: Opioid Use Disorder
Buprenorphine
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: University of Utah
First posted: 2024-06-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Single-blind, fixed-order, dose-escalation design. All participants (n=10) will first receive XR-BUP 16mg in single-blind fashion. If at least 90% successfully complete induction (success defined as experiencing no BPOW) with the 16mg dose, then we will proceed to the 24mg dose. If at least 90% successfully complete induction the 24mg dose, then we will proceed to the 32mg dose.
Primary purpose: OTHER

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 DSM-5 diagnosis of OUD (n=30) will be admitted to an inpatient unit to complete study procedures over the course of 5 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.

Detailed description: The approach is to conduct a single ascending dose trial in a controlled human laboratory setting with individuals with a DSM-5 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 5 days-4 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, 24, 48 and 72 hours after the XR-BUP injection.

Eligibility criteria: Inclusion Criteria:

* English speaking adults aged 18 and above.
* DSM-5 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 DSM-5 diagnosis of alcohol or sedative/hypnotic use disorder.
* Physical dependence on alcohol or sedative/hypnotics.
* Psychotic disorder, active suicidality or homicidally or any psychiatric condition that impair ability to provide informed Consent.
* Requiring treatment with opioids for acute or chronic pain.
* History of hypersensitivity or allergy to buprenorphine or fentanyl.
* Pregnant or breastfeeding.

Primary outcomes:
measure: Safety and tolerability of XR-Buprenorphine
timeFrame: For the duration of the inpatient admission, lasting 4 days after receipt of study drug.
measure: Plasma-concentration curves (AUC) of buprenorphine.
timeFrame: Baseline, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours after study drug administration.
Secondary outcomes:
measure: Maximum Plasma Concentration
timeFrame: Baseline, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours after study drug administration.
measure: Minimum Plasma Concentration (Cmin),
timeFrame: Baseline, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours after study drug administration.
measure: Time to Maximum Plasma Concentration
timeFrame: Baseline, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours after study drug administration.
measure: Elimination half-life
timeFrame: Baseline, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours after study drug administration.
measure: Buccal Swab
timeFrame: will be done once at the baseline visit.
Other outcomes:
Locations:
Study officials:
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