Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04815590
Other study ID # BCCSU-004
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT04157062 - An Open-Label Trial of Repetitive Transcranial Magnetic Stimulation for Opioid Use Disorder N/A
Enrolling by invitation NCT04527926 - STEPuP: Prenatal Provider Education and Training to Improve Medication-assisted Treatment Use During Pregnancy N/A
Completed NCT04505540 - Start Treatment and Recovery for Opioid Use Disorder N/A
Completed NCT03065049 - Transforming Recovery Through Exercise and Community N/A
Completed NCT04080037 - Assessing Opioid Care Practices Using CPV Patient Simulation Modules N/A
Recruiting NCT05118204 - Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization Phase 4
Suspended NCT05001789 - Cognitive Functioning in Opioid Use Disorder N/A
Active, not recruiting NCT04650386 - Examining an Adaptive Approach to Providing Psychosocial Support to Buprenorphine Patients N/A
Completed NCT03715634 - Study of a Novel Subcutaneous Depot Formulation of Buprenorphine Phase 1
Enrolling by invitation NCT04991974 - Opioid Use Disorder Treatment Linkage at Sexual Health Clinics Using Buprenorphine Phase 2/Phase 3
Completed NCT04122755 - Single Ascending Dose Study of ALA-1000 Phase 1
Recruiting NCT05049460 - Adjunctive Transcranial Stimulation to Reduce Impulsivity in Opiate Use Disorder N/A
Recruiting NCT04927143 - Encouraging Abstinence Behavior in a Drug Epidemic Phase 2
Recruiting NCT05028998 - COVID-19-Related Opioid Treatment Policy Evaluation
Completed NCT05047627 - Digital Intervention to Treat Anxiety and Depression Among Persons Receiving Treatment for Opioid Use Disorder N/A
Active, not recruiting NCT04129580 - reSET-O RCT (Randomized Controlled Trial) N/A
Recruiting NCT03923374 - Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes
Completed NCT04464421 - SMART Effectiveness Trial N/A
Suspended NCT02687360 - Imaging the Effects of rTMS on Chronic Pain N/A
Completed NCT04056182 - Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment Phase 2