Recruiting

Buprenorphine

Sponsor:

BC Centre on Substance Use

Code:

NCT04815590

Conditions

Opioid-Use Disorder

Opioid Overdose

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT04815590

Start date

Oct 17, 2022

Status verified date

Nov, 2022

Completion date

Oct 17, 2023

Anticipated

Primary completion date

Oct 17, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Number of XR-BUP injections received [ Time Frame: 24 weeks ]
  • Proportion of treatment-engaged visits per participant [ Time Frame: 24 weeks ]

Central Contacts and Locations

Central contacts

Locations

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

Recruiting

Vancouver, British Columbia, Canada, V6Z 1Y6

Contacts

More Information

Sponsor

BC Centre on Substance Use

Last update posted

Nov 17, 2022

Last verified

Nov, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by BC Centre on Substance Use on 2022-11-17.