CompletedNCT03861338Updated Mar 9, 2021Results posted

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

A Phase 1/2 interventional study of Sublocade in Opioid-use Disorder, sponsored by New York State Psychiatric Institute. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-03-09.

Sponsored by New York State Psychiatric Institute · Phase 1/2, Interventional, and Treatment

Phase: Phase 1/2
Study type: Interventional
Enrollment: 11
Allocation: Not applicable
Ages: 18 Years to 65 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Opioid-use Disorder

Browse trials for

Opioid-Related Disorders 1,411

Keywords

opioid use disorder, sublocade, buprenorphine

In context

Opioid-Related Disorders

1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.

This study's enrollment of 11 is below the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.

Browse Opioid-Related Disorders studies →

Lead sponsor

New York State Psychiatric Institute is the lead sponsor of 425 studies on the registry; 26 are open to participants now.

Of its 50 completed or terminated interventional studies of FDA-regulated products, 45 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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

Exclusion criteria

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 (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.

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 11 participants (actual)

Study arms

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

Interventions

DrugSublocade
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

What researchers measure

Primary outcomes

Sublocade Induction
Number of participants successfully inducted onto Sublocade (BXR)
Time frame: Study week 1

Results

Posted Mar 9, 2021

Participant flow

Participant flow — Overall Study
Milestone	Sublocade
Started	10
Completed	8
Not completed	2

Outcome measures

PrimarySublocade Induction

Number of participants successfully inducted onto Sublocade (BXR)

Time frame:: Study week 1
Reported as:: Count of participants · Participants

Sublocade Induction
Participants	Sublocade
Sublocade Induction	10

Adverse events

Collected over 12 weeks of study. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Sublocade	0/10 (0%)	0/10 (0%)	9/10 (90%)

Most frequent other events

Showing 10 of 20

Most frequent other events
Event	Sublocade
opioid withdrawalGeneral disorders	9/10
coughRespiratory, thoracic and mediastinal disorders	3/10
injection site painSkin and subcutaneous tissue disorders	3/10
anorexiaGastrointestinal disorders	2/10
headacheGeneral disorders	2/10
pruritisSkin and subcutaneous tissue disorders	2/10
blurred visionEye disorders	1/10
constipationGastrointestinal disorders	1/10
depressionPsychiatric disorders	1/10
difficulties with memoryNervous system disorders	1/10

Baseline characteristics

10 participants who initiated the induction process

Age, Continuous
Age, Continuous(years)	Sublocade
Mean	37.4 ± 9.2

Sex: Female, Male
Sex: Female, Male(Participants)	Sublocade
Female	1
Male	9

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Sublocade
Hispanic or Latino	4
Not Hispanic or Latino	6
Unknown or Not Reported	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Sublocade
American Indian or Alaska Native	0
Asian	0
Native Hawaiian or Other Pacific Islander	0
Black or African American	3
White	3
More than one race	4
Unknown or Not Reported	0

Region of Enrollment
Region of Enrollment(participants)	Sublocade
United States	10

Study locations

1 site

Substance Treatment Research Service (STARS) of Columbia University
New York, New York 10019, United States

References and documents

Study documents

Study protocol · Feb 27, 2019
Statistical analysis plan · Feb 25, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Individual participant data that underlie the results published in this report (after de-identification) (text, tables, figures)

Supporting information: Study protocol, Sap, Icf

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 9, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03861338
Lead sponsor: New York State Psychiatric Institute
Responsible party: John Mariani MD (Research Psychiatrist, New York State Psychiatric Institute) — Principal investigator
First posted: Mar 4, 2019
Start date: Mar 1, 2019
Primary completion: Feb 28, 2020
Completion: Feb 28, 2020
Results posted: Mar 9, 2021
Last update: Mar 9, 2021

Study contacts

John Mariani, MD

principal investigator · New York Psychiatric Institute

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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