Status:
NOT_YET_RECRUITING
Assessing the Acceptability, Feasibility, Effectiveness and Cost-effectiveness of LADB
Lead Sponsor:
PATH
Collaborating Sponsors:
UNITAID
World Health Organization
Conditions:
Opioid Dependence
Eligibility:
All Genders
18+ years
Brief Summary
The goal of the proposed study is to generate evidence on the acceptability, feasibility, effectiveness, and cost-effectiveness of introducing long-acting depot buprenorphine (LADB) as an additional o...
Detailed Description
Despite the proven effectiveness of opioid agonist maintenance treatment (OAMT), its coverage and use remain low globally and, particularly, in low- and middle-income countries (LMIC), in part due to ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
760 Patients enrolled
Trial Details
Trial ID
NCT06129916
Start Date
November 1 2025
End Date
June 30 2027
Last Update
October 7 2025
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