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

NCT04815590 | Unknown

• 1 other identifier: BCCSU-004
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Opioid-Use Disorder; Opioid Overdose

Outcome Measures

Primary Outcomes (2)

• Number of XR-BUP injections received

  The primary outcome for this study will be retention in treatment, defined as having received the six scheduled XR-BUP injections and completed the EOS/Early Termination visit.

  24 weeks

• Proportion of treatment-engaged visits per participant

  Proportion of treatment-engaged visits per participant will be calculated as the number of received XR-BUP injections divided by the number of scheduled injections (i.e., six).

  24 weeks

Secondary Outcomes (2)

• Percentage of opioid free weeks

  24 weeks

• Safety monitoring

  24 weeks

Study Arms (1)

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.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Approximately 40 eligible participants are planned to be enrolled into the study. Interested individuals must meet all of the inclusion criteria and none of the exclusion criteria to be eligible for the study.

You may qualify if:

• Participants must meet ALL the following criteria to be eligible to participate for the study:
• Be above 19 years of age;
• Be diagnosed with moderate or severe OUD as evidenced by their approval for treatment with XR-BUP (Sublocade);
• 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);
• Have a new prescription for XR-BUP, but have not yet initiated treatment;
• Be able and willing to follow study procedures;
• Be able to provide adequate locator information (e.g., phone number and at least one emergency contact);
• Be able and willing to provide written informed consent;
• 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).

You may not qualify if:

• Participants will be excluded from the study if ANY of the following criteria are met:
• Be on OAT other than buprenorphine/naloxone in the 7 days prior to screening;
• Be on a stable buprenorphine/naloxone dose for more than 27 days prior to screening;
• Use of an investigational drug in the 30 days prior to screening;
• Incarcerated, pending legal action or other reasons that might prevent completion of the study.

Sponsors & Collaborators

• BC Centre on Substance Use: lead
• Indivior Inc.: collaborator

Study Sites (1)

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

Vancouver, British Columbia, V6Z 1Y6, Canada

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders; Opiate Overdose

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Drug Overdose; Prescription Drug Misuse; Drug Misuse

Study Officials

• M. Eugenia Socias, MD, MSc.

  Assistant Professor, Department of Medicine, University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Piper Dickhout, BSc

CONTACT

604-364-7006; piper.dickhout@bccsu.ubc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Medicine, UBC; Research Scientist, BCCSU

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 25, 2021
• Study Start: October 17, 2022
• Primary Completion: October 17, 2023
• Study Completion: October 17, 2023
• Last Updated: November 17, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)