Extended-release Injectable Buprenorphine for Individuals at High Risk of Overdose

NCT ID: NCT04815590

Last Updated: 2022-11-17

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-17
• Study Completion Date: 2023-10-17

Brief Summary

This pilot study will evaluate the feasibility and clinical utility of extended-release injectable buprenorphine (XR-BUP) for the treatment of opioid use disorder (OUD) among individuals at high-risk for overdose (OD).

Detailed Description

FASTER-BUP is a 24-week observational pilot study evaluating the feasibility and clinical utility of XR-BUP (brand name: Sublocade) for the treatment of OUD among individuals at high-risk of OD. Forty participants with moderate to severe OUD starting treatment with XR-BUP as part of standard of care will be followed.

Conditions

Opioid-Use Disorder; Opioid Overdose

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Sublocade

The only group consists of participants with moderate to severe OUD who will be starting treatment with extended-release injectable buprenorphine as part of standard of care. While individual treatment regimens may vary, these will often consist of 2 once-monthly 300 mg subcutaneous injections followed by 4 once-monthly 100 mg subcutaneous injections. However, participants may receive once-monthly 300 mg subcutaneous injections in place of 100 mg subcutaneous injections for as many months as is deemed necessary by their prescribing physician.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

Participants must meet ALL the following criteria to be eligible to participate for the study:

1. Be above 19 years of age;

2. Be diagnosed with moderate or severe OUD as evidenced by their approval for treatment with XR-BUP (Sublocade);

3. Be at high-risk for recurrent overdose, defined as having experienced a recent non-fatal overdose within the past 6 months (e.g., admission to the emergency department for an overdose OR self-reported OD that required Naloxone administration OR had an overdose where an ambulance arrived at the scene);

4. Have a new prescription for XR-BUP, but have not yet initiated treatment;

5. Be able and willing to follow study procedures;

6. Be able to provide adequate locator information (e.g., phone number and at least one emergency contact);

7. Be able and willing to provide written informed consent;

8. Be able to understand, communicate and speak with the research staff. Non-English speaking individuals will require a translator to be present during all study visits and during all study activities. The translator will be independent (e.g., not known to the participant to prevent the risk for coercion or misrepresentation).

Exclusion Criteria

Participants will be excluded from the study if ANY of the following criteria are met:

1. Be on OAT other than buprenorphine/naloxone in the 7 days prior to screening;

2. Be on a stable buprenorphine/naloxone dose for more than 27 days prior to screening;

3. Use of an investigational drug in the 30 days prior to screening;

4. Incarcerated, pending legal action or other reasons that might prevent completion of the study.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indivior Inc.

INDUSTRY

Sponsor Role: collaborator

BC Centre on Substance Use

OTHER

Sponsor Role: lead

Responsible Party

M. Eugenia Socias

Assistant Professor, Department of Medicine, UBC; Research Scientist, BCCSU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

M. Eugenia Socias, MD, MSc.

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor, Department of Medicine, University of British Columbia

Locations

Rapid Access Addiction Clinic (RAAC), St. Paul's Hospital

Vancouver, British Columbia, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Piper Dickhout, BSc

Role: CONTACT

piper.dickhout@bccsu.ubc.ca

604-364-7006

Facility Contacts

Piper Dickhout, BSc

Role: primary

piper.dickhout@bccsu.ubc.ca

604-364-7006

Other Identifiers

BCCSU-004

Identifier Type: -

Identifier Source: org_study_id