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

StatusNot Yet Recruiting
PhaseNot specified
SponsorPATH
Started
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Record History

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  1. Primary completion date: May 31, 2026 to Dec 31, 2026
    • Start date: Nov 1, 2024 to Nov 1, 2025
    • Enrollment target: 1050 to 760
    • Study completion date: Dec 31, 2026 to Jun 30, 2027
    v5
  2. Start date: Apr 1, 2024 to Nov 1, 2024v4
  3. Collaborators: 3 to 12v3
  4. Secondary endpoints revised (11)v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
PATH
7 trials monitored
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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.
Trial Details
NCT Number NCT06129916
Lead Sponsor PATH
Collaborators: UNITAID, World Health Organization, Médecins du Monde, Frontline AIDS, London School of Hygiene and Tropical Medicine, International Network of People who Use Drugs, Monash University, Population Services International, Burnet Institute, University of Bristol, Alliance for the Public's Health, Coact Technical Support Limited
Conditions
(from sponsor)		 Opioid Dependence
Related terms Opioid-Related Disorders
Enrollment 760 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov