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

Completed · Phase 1/Phase 2

Conditions studied: Opioid-use Disorder

In brief

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.

Key facts

Study ID

NCT03861338

Run by

New York State Psychiatric Institute

People needed

11

Starts

2019-03-01

Expected to finish

2020-02-28

Last updated by the study team

2021-03-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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
• 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.

Where it is running

• Substance Treatment Research Service (STARS) of Columbia University — New York, New York, United States

Full record on ClinicalTrials.gov

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