Assessing the Acceptability, Feasibility, Effectiveness and Cost-effectiveness of LADB (NCT06129916) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Assessing the Acceptability, Feasibility, Effectiveness and Cost-effectiveness of LADB
760 participantsStarted 2025-11-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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