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

NCT03861338 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: 7764
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Opioid-use Disorder

Keywords

opioid use disorder, sublocade, buprenorphine

Outcome Measures

Primary Outcomes (1)

• Sublocade Induction

  Number of participants successfully inducted onto Sublocade (BXR)

  Study week 1

Study Arms (1)

sublocade

EXPERIMENTAL

Sublocade buprenorphine extended-release (BXR) injection, 300 mg and 100 mg

Drug: Sublocade

Interventions

Sublocade DRUG

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.

Also known as: buprenorphine extended-release injection

sublocade

Eligibility Criteria

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

You may qualify if:

• Individuals between the ages of 18-65
• Voluntarily seeking treatment for opioid use
• Meets current DSM-5 (Diagnostic and Statistical Manual) 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

You may not qualify if:

• 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 (aspartate transaminase) and ALT (alanine aminotransferase) \>3 times the upper limit of normal
• Legally mandated to substance use disorder treatment
• 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.

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

Substance Treatment Research Service (STARS) of Columbia University

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Sublocade

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: John Mariani MD
• Organization: New York State Psychiatric Institute

john.mariani@nyspi.columbia.edu

6467748181

Study Officials

• John Mariani, MD

  New York Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Psychiatrist

Model Details: open label pilot for sublocade

Study Record Dates

• First Submitted: March 1, 2019
• First Posted: March 4, 2019
• Study Start: March 1, 2019
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: March 9, 2021
• Results First Posted: March 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: beginning 3 months and ending 5 years after article publication
• Access Criteria: to researcher who provides a methodologically sound proposal to achieve aims in the approved proposal

Locations

US (1)