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

Opioid-Use Disorder Clinical Trial

— FASTER-BUP  

Official title:

Pilot Study to Assess the Feasibility, Efficacy and Safety of Extended-release Injectable Buprenorphine for the Treatment of Opioid Use Disorder Among Individuals at High Risk of Overdose

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04815590
• Other study ID #: BCCSU-004
• Status: Recruiting
• Start date: October 17, 2022
• Est. completion date: October 17, 2023

Study information

• Verified date: November 2022
• Source: BC Centre on Substance Use
• Contact: Piper Dickhout, BSc
• Phone: 604-364-7006
• Email: piper.dickhout[@]bccsu.ubc.ca
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 17, 2023
• Est. primary completion date: October 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Drug Overdose
• Opiate Overdose
• Opioid Overdose
• Opioid-Related Disorders
• Opioid-Use Disorder

Locations

Country	Name	City	State
Canada	Rapid Access Addiction Clinic (RAAC), St. Paul's Hospital	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
BC Centre on Substance Use	Indivior Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Percentage of opioid free weeks	Suppression of illicit opioid use will be measured as the percentage of opioid-free weeks during the active treatment period (Visit 2 to Visit 8), using a combination of Urine Drug Test (UDT) results and self-reported illicit opioid use.	24 weeks
Secondary	Safety monitoring	Descriptive statistics will be used for all safety analysis variables. No formal inferential tests will be performed on safety data.; The incidence of all AEs will be summarized by body system, severity, seriousness, and relationship to the study drug using MedDRA. SAEs will be tabulated by patient.; Descriptive statistics will be reported for injection site grading.	24 weeks