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

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 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.

Conditions

• Opioid Dependence

Interventions

DRUG

long-acting depot buprenorphine (LADB)

The intervention will measure patient-centered outcomes in people initiating LADB among a cohort of opioid-dependent PWID across sites in the seven project LMIC. Study participants will be enrolled from selected clinics that deliver routine opioid agonist maintenance treatment to PWID. The intervention will 1) Compare characteristics at baseline of those service clients who do and do not initiate LADB in relation to demographic characteristics, history of drug use, and outcomes; 2) Measure side effects and adverse events among those initiating LADB; and 3) Where appropriate, assess changes in outcomes between time of LADB initiation and 48 week follow-up, including HCV and HIV testing and treatment, quality of life, employment opportunities, and service preferences.

Sponsors & Collaborators

• UNITAID

  collaborator OTHER

• World Health Organization

  collaborator OTHER

• Médecins du Monde

  collaborator OTHER

• Frontline AIDS

  collaborator OTHER

• London School of Hygiene and Tropical Medicine

  collaborator OTHER

• International Network of People who Use Drugs

  collaborator UNKNOWN

• Monash University

  collaborator OTHER

• Population Services International

  collaborator OTHER

• Burnet Institute

  collaborator OTHER

• University of Bristol

  collaborator OTHER

• Alliance for the Public's Health

  collaborator OTHER

• Coact Technical Support Limited

  collaborator UNKNOWN

• PATH

  lead OTHER

Principal Investigators

• Kimberly Green · PATH

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-11-01

Primary Completion

2026-12-31

Completion

2027-06-30

FDA Drug

Yes