Opioid-Use DisorderFASTER-BUPNCT04815590
Extended-release Injectable Buprenorphine for Individuals at High Risk of Overdose
An observational study of Opioid-Use Disorder and Opioid Overdose, run by BC Centre on Substance Use at 1 site in Canada.
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). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Opioid-Use Disorder, Opioid Overdose
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 17 Oct 2022to 17 Oct 2023
- How long will I take part?
- 24 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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;
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- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Rapid Access Addiction Clinic (RAAC), St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
Piper Dickhout, BSc, 604-364-7006, piper.dickhout@bccsu.ubc.ca
Seonaid Nolan, MD
About this study
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
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).
Read the 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
- Medical subject headings
- Opioid-Related Disorders, Opiate Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 24 weeks
Secondary outcomes (2)
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.
Measured: 24 weeks
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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start17 Oct 2022
- Primary completion17 Oct 2023 (estimated)
- Study completion17 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 24 Weeks
Sponsor and investigators
- Lead sponsor
- BC Centre on Substance Use
- Sponsor type
- University, hospital or other
- Collaborators
- Indivior Inc.
- Responsible party
- Principal investigator, M. Eugenia Socias, BC Centre on Substance Use
- Investigators
- M. Eugenia Socias, MD, MSc., Principal investigator, Assistant Professor, Department of Medicine, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04815590
- Sponsor's protocol ID
- BCCSU-004
- Acronym
- FASTER-BUP
- Status last verified
- Nov 2022
- First submitted
- 2 Mar 2021
- Last updated
- 17 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04815590
- Acronym / sponsor ID
- FASTER-BUP / BCCSU-004
- Conditions
- Opioid-Use Disorder, Opioid Overdose
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- BC Centre on Substance UseUniversity, hospital or other
- Collaborators
- Indivior Inc.
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 17 Oct 2023 (estimated)
- Study completion
- 17 Oct 2023 (estimated)
- First posted
- 25 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of XR-BUP injections received
Time frame: 24 weeks
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.
Proportion of treatment-engaged visits per participant
Time frame: 24 weeks
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).
2 secondary outcomes
Percentage of opioid free weeks
Time frame: 24 weeks
Safety monitoring
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M. Eugenia Socias, MD, MSc. principal investigator
Assistant Professor, Department of Medicine, University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid-Use Disorder and Opioid Overdose, run by BC Centre on Substance Use at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Piper Dickhout, BSc (604-364-7006, piper.dickhout@bccsu.ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of XR-BUP injections received (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2022.