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

NCT06129916 | Not Yet Recruiting FDA Drug

• 1 other identifier: RES-00617
• Study Type: observational
• Target: 760
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Opioid Dependence

Outcome Measures

Primary Outcomes (3)

• Treatment Satisfaction Questionnaire for Medication 1.4 assessed through patient reported outcomes on effectiveness, side-effects, convenience and global satisfaction in relation to the medication

  The primary measure for treatment satisfaction will be collected through the Treatment Satisfaction Questionnaire for Medication 1.4 at 48 weeks. This is a generic measure of treatment satisfaction with medication. It has 14 questions divided into subscales (effectiveness; side effects, convenience and global satisfaction). Response are on a Likert-scale of 5 or 7 points except for 1 yes/no question on the presence of side effects. The scores are calculated for each of the subscales, which range from 0 to100 with higher scores indicating higher patient satisfaction with medication.

  48 weeks

• Retention in Care

  The primary measure for retention in care will be estimated as the proportion of people on LADB at 48 weeks

  48 weeks

• Nonmedical opioid use

  Assess degree of non-medical opioid use in the last month measured at week 48, in terms of number of days that non-medical opioids were not used in the last 4 weeks.

  48 weeks

Secondary Outcomes (11)

• % of participants who have received testing for HIV and Hepatitis C (HCV) at 48 weeks, frequency of testing, % testing positive for antibodies to HIV or HCV and % linked to treatment and % retained into treatment

  48 weeks

• % of participants with self reported symptoms of depression at 48 weeks.

  48 weeks

• % of participants with self-reported symptoms of anxiety at 48 weeks.

  48 weeks

• % of participants reporting recent thoughts of or attempts at suicide at 48 weeks.

  48 weeks

• Patient-reported outcomes using the EuroQol measures of health status

  48 weeks

Study Arms (2)

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

Drug: long-acting depot buprenorphine (LADB)

PWID who opt for standard of care

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

Interventions

long-acting depot buprenorphine (LADB) 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 LADB

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Sites will set a target for participation among women in line with the percentage of women accessing needle/syringe programmes and OAMT locally. Where data are not currently available on gender or if attendance is very low, we aim to recruit a minimum quota of 10% to ensure meaningful participation among women.
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will collect data from participants with opioid use disorder across eight diverse LMIC: Egypt, India, Kyrgyzstan, Nigeria, South Africa, Tanzania, Ukraine, and Vietnam.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PATH: lead
• 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

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Kimberly Green

  PATH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kimberly Green, MA, PhD

CONTACT

+1(202)-515-0626; kgreen@path.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: November 13, 2023
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share