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

NCT ID: NCT06129916

Last Updated: 2025-10-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 760 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2027-06-30

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 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.

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 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.

Conditions

Opioid Dependence

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

PWID who opt for LADB

People with opioid dependence who opt to initiate LADB across a range of LMIC settings over a 48-week period

long-acting depot buprenorphine (LADB)

Intervention Type: DRUG

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.

PWID who opt for standard of care

People with opioid dependence who refuse to initiate LADB and opt for standard of care

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UNITAID

OTHER

Sponsor Role: collaborator

World Health Organization

OTHER

Sponsor Role: collaborator

Médecins du Monde

OTHER

Sponsor Role: collaborator

Frontline AIDS

OTHER

Sponsor Role: collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role: collaborator

International Network of People who Use Drugs

UNKNOWN

Sponsor Role: collaborator

Monash University

OTHER

Sponsor Role: collaborator

Population Services International

OTHER

Sponsor Role: collaborator

Burnet Institute

OTHER

Sponsor Role: collaborator

University of Bristol

OTHER

Sponsor Role: collaborator

Alliance for the Public's Health

OTHER

Sponsor Role: collaborator

Coact Technical Support Limited

UNKNOWN

Sponsor Role: collaborator

PATH

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kimberly Green

Role: PRINCIPAL_INVESTIGATOR

PATH

Central Contacts

Kimberly Green, MA, PhD

Role: CONTACT

kgreen@path.org

+1(202)-515-0626

Other Identifiers

RES-00617

Identifier Type: -

Identifier Source: org_study_id