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

Opioid Dependence Clinical Trial

Official title: Assessing the Acceptability, Feasibility, Effectiveness and Cost-effectiveness of Long-acting Depot Buprenorphine (LADB) for the Treatment of Opioid Dependence in Low- and Middle-income Countries (LMIC): a Multicentre International Study

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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 challenges related to limited choice of OAMT medication and dosing options. The long-acting depot buprenorphine (LADB) formulation of OAMT, with either weekly or monthly administration, could provide a more discreet, convenient, and less stigmatizing form of treatment and the potential to improve client retention in care, as well as economic stability. It therefore may address unmet need among individuals who could benefit from OAMT and are not already taking it or who would prefer a long-acting option over current OAMT options. Studies have demonstrated the effectiveness and acceptability of LADB among those with opioid dependence in high-income settings. However, there are no known such studies conducted in LMIC.

The aim of the study is to determine the acceptability, feasibility, effectiveness, public health impact, and cost-effectiveness of introducing LADB in a range of LMIC.

The study will collect data from participants with opioid use disorder, service providers, and health policymakers/decision-makers across seven diverse LMIC: Egypt, India, Kyrgyzstan, South Africa, Tanzania, Ukraine, and Vietnam.

This is a multicenter, mixed-method study designed with community engagement and co-production. The study consists of four interlinked modules: Module 1 (feasibility) includes a process evaluation to monitor implementation and assess barriers, drawing on program data and interviews with service providers and other key stakeholders; Module 2 (effectiveness) involves a prospective cohort choice study among people with opioid dependence, initiating LADB and following up over 48 weeks; Module 3 (values and preferences, plus acceptability) includes key informant interviews and focus group discussions with people with opioid dependence to understand overall acceptability, values, preferences, experiences, and concerns relating to LADB; Module 4 (public health impact and cost-effectiveness) involves modeling based on collected data to estimate impact and cost-effectiveness of LADB in LMIC settings. ;

Related Conditions & MeSH terms

• Opioid Dependence
• Opioid-Related Disorders

• NCT number: NCT06129916
• Study type: Observational
• Source: PATH
• Contact: Kimberly Green, MA, PhD
• Phone: +1(202)-515-0626
• Email: kgreen@path.org
• Status: Not yet recruiting
• Start date: April 1, 2024
• Completion date: December 31, 2026