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

Primary Purpose

Opioid-use Disorder

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Sublocade

About this trial

This is an interventional treatment trial for Opioid-use Disorder focused on measuring opioid use disorder, sublocade, buprenorphine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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.

Sites / Locations

Substance Treatment Research Service (STARS) of Columbia University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

sublocade

Arm Description

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

Outcomes

Primary Outcome Measures

Sublocade Induction

Number of participants successfully inducted onto Sublocade (BXR)

Secondary Outcome Measures

Full Information

NCT ID

NCT03861338

First Posted

March 1, 2019

Last Updated

February 16, 2021

Sponsor

New York State Psychiatric Institute

1. Study Identification

Unique Protocol Identification Number

NCT03861338

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

March 1, 2019 (Actual)

Primary Completion Date

February 28, 2020 (Actual)

Study Completion Date

February 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

New York State Psychiatric Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Opioid-use Disorder

Keywords

opioid use disorder, sublocade, buprenorphine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Model Description

open label pilot for sublocade

Masking

None (Open Label)

Allocation

N/A

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

sublocade

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Sublocade

Other Intervention Name(s)

buprenorphine extended-release injection

Intervention Description

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.

Primary Outcome Measure Information:

Title

Sublocade Induction

Description

Number of participants successfully inducted onto Sublocade (BXR)

Time Frame

Study week 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John Mariani, MD

Organizational Affiliation

New York Psychiatric Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Substance Treatment Research Service (STARS) of Columbia University

City

New York

State/Province

New York

ZIP/Postal Code

10019

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Individual participant data that underlie the results published in this report (after de-identification) (text, tables, figures)

IPD Sharing Time Frame

beginning 3 months and ending 5 years after article publication

IPD Sharing Access Criteria

to researcher who provides a methodologically sound proposal to achieve aims in the approved proposal

Learn more about this trial

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

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