Assessing the Acceptability, Feasibility, Effectiveness and Cost-effectiveness of LADB

Launched by PATH · Nov 10, 2023

Keywords

ClinConnect Summary

This clinical trial is focused on evaluating a new treatment option called long-acting depot buprenorphine (LADB) for people who are dependent on opioids, particularly those who inject drugs. The study aims to understand how acceptable and effective this treatment is, how feasible it is to implement in low- and middle-income countries, and whether it is cost-effective. The results will help shape future healthcare policies and guidelines for providing better access to this treatment.

To participate in the trial, individuals must be at least 18 years old and diagnosed with opioid dependence by a certified clinician. They should not be pregnant and must be willing to follow the study protocols. Participants will receive LADB and will need to attend clinic visits regularly to ensure their safety and adherence to the treatment plan. It's important to note that individuals with certain medical conditions or those currently undergoing other specific treatments may not be eligible for this study. Overall, this trial is a step toward improving treatment options for opioid dependence in regions where support may be limited.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Are 18 years old or older.
• • Are verified (by certified clinician) opioid dependents according to the International Classification of Diseases 11th Revision.
• • Are not pregnant (verified by screening).
• • Are eligible to receive OAMT at a participating site.
• • Consent to attend the clinic and adhere to clinical protocols
• • Have the capacity to consent to participating in research.
• • Provide written informed consent.
• Exclusion Criteria:
• • Have a history or presence of an allergic or adverse response (including rash or anaphylaxis) to BUP or the Atrigel® delivery system (a registered trademark of Tolmar Therapeutics Inc.) if Sublocade is chosen.
• • Have any contraindication to BUP or methadone.
• • Show signs of clinically significant medical conditions which would compromise compliance with the protocol and/or client safety in line with clinical guidelines for the administration of injectable BUP for OAMT.
• • Are currently taking oral or depot naltrexone therapy or are enrolled in any form of naltrexone therapy within 30 or 90 days prior to study screening, respectively.
• • Are in thepost partum period (defined as 6 weeks) or confirmed as pregnant.
• • Have an inability or unwillingness to provide informed consent or abide by the requirements of the study.