Extended-release Buprenorphine as a Novel Low-dose Induction Strategy
Brigham and Women's Hospital
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.
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 d…
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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…
Interventions
- DrugExtended-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.
Location
- Brigham and Women's HospitalBoston, Massachusetts