An Open-Label Pilot Study of Sublocade as Treatment for Opiate Use Disorder

Overview

The proposed study is a 12-week, open-label pilot study of sublocade (extended-release burprenorphine, BXR) as treatment for opiate use disorder (OUD) testing positive for Highly Potent Synthetic Opioids (HPSO). The investigators plan to enroll 10 participants into the study.

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 30, 2020

Detailed Description

This is an open-label, uncontrolled pilot study. Outpatients seeking treatment for Opiate Use Disorder (OUD) will be screened, and those eligible who are positive for fentanyl analogues at screening will be consented and inducted onto sublingual buprenorphine (target dose 16mg to 24mg). On the fourth day after starting the buprenorphine induction, participants will receive sublocade (BXR) 300mg by subcutaneious injection. Participants will be seen twice per week for urine collection for toxicology and research assessments and will have Medication Management counseling weekly during one of these visits. BXR will be administered monthly and dosing will be according to the FDA prescribing instructions of 300mg for the second dose and 100mg for the third.

Interventions

  • Drug: Sublocade
    • The monthly Sublocade buprenorphine extended-release (BXR) injection will be administered in two doses (100 mg and 300 mg). Following a 4 day induction onto oral buprenorphine, the first 300 mg injection of Sublocade will be administered. A second 300 mg Sublocade injection will be administered 1 month later and the third and final monthly injection of 100 mg of Sublocade will be administered 2 months post the successful buprenorphine induction.

Arms, Groups and Cohorts

  • Experimental: sublocade
    • Sublocade buprenorphine extended-release (BXR) injection, 300 mg and 100 mg

Clinical Trial Outcome Measures

Primary Measures

  • Change in days of opioid use per week
    • Time Frame: collected during 1 week of baseline prior to study entry and during 12 weeks of study or length of participation
    • comparing days of opioid use during baseline week to the last week of participation in the trial

Participating in This Clinical Trial

Inclusion Criteria

  • Individuals between the ages of 18-65
  • Voluntarily seeking treatment for opioid use
  • Meets current DSM-5 criteria for Opioid Use Disorder (OUD) as a primary diagnosis, with at least moderate severity
  • Test positive for Highly Potent Synthetic Opioids (HPSO) use
  • Able to provide informed consent and comply with study procedures

Exclusion Criteria

  • Meets DSM-5 criteria for substance use disorder other than opioid as the primary diagnosis
  • Having a comorbid psychiatric diagnosis that might interfere with participation or make participation hazardous, such as an active psychotic disorder or current suicide risk
  • Methadone maintenance treatment
  • Buprenorphine maintenance treatment
  • Known history of allergy, intolerance, or hypersensitivity to candidate medication (buprenorphine)
  • Pregnancy, lactation, or failure to use adequate contraceptive methods in female patients, male participants are required to use adequate forms of birth control as the exposure to Sublocade on sperm and subsequent fetal development are not known.
  • Unstable medical conditions, which might make participation hazardous such as uncontrolled hypertension (blood pressure >150/100), acute hepatitis, uncontrolled diabetes, or elevated liver function tests (AST and ALT >3 times the upper limit of normal
  • Legally mandated to substance use disorder treatment
  • Current physiological dependence on alcohol or sedative-hypnotics that would require a medically supervised detoxification-other substance use diagnoses are not exclusionary
  • Individuals, who in the clinicians judgment, have a history of failed trial of buprenorphine or sublocade (e.g. history of severe opioid intoxication or overdoses despite adequate adherence to buprenorphine or sublocade), or other features of the history that strongly suggest the patient is not a good candidate for outpatient treatment with buprenorphine.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • New York State Psychiatric Institute
  • Provider of Information About this Clinical Study
    • Principal Investigator: John Mariani MD, Research Psychiatrist – New York State Psychiatric Institute
  • Overall Official(s)
    • John Mariani, MD, Principal Investigator, New York Psychiatric Institute

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