Assessing the Acceptability, Feasibility, Effectiveness and Cost-effectiveness of LADB
ConditionOpioid Dependence
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPATH
About this trial
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 option for the treatment of opioid dependence in low- and middle-income countries (LMIC) among people who inject drugs (PWID) with opioid dependence. The study results will be used to inform global and local policies and guidelines to introduce LADB as a treatment option and to advocate for access to a sustainable supply of LADB in LMIC.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- long-acting depot buprenorphine (LADB)
Treatment groups
760 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
PATH
Lead sponsor
UNITAID
Collaborator
World Health Organization
Collaborator
Médecins du Monde
Collaborator
Frontline AIDS
Collaborator
London School of Hygiene and Tropical Medicine
Collaborator
International Network of People who Use Drugs
Collaborator
Monash University
Collaborator
Population Services International
Collaborator
Burnet Institute
Collaborator
University of Bristol
Collaborator
Alliance for the Public's Health
Collaborator
Coact Technical Support Limited
Collaborator
Source ClinicalTrials.gov