Opioid DependenceNCT06129916
Assessing the Acceptability, Feasibility, Effectiveness and Cost-effectiveness of LADB
An observational study of Opioid Dependence, run by PATH.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Dependence
- What is being tested?
- long-acting depot buprenorphine (LADB)
- How many people
- 760 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2025to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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
- Being tested
- long-acting depot buprenorphine (LADB)
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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
Retention into HIV treatment will be measured through self-report using a predefined threshold of adherence (80 to 100%) in consultation with sites as well as through recoding return visits for medication refills. Retention into HCV treatment will be measured as the proportion of those completing treatment and who have sustained virologic response 12 weeks after treatment. These data will be extracted from clinical records at programme sites.
Measured: 48 weeks
% of participants with self reported symptoms of depression at 48 weeks.
Measured through the self-completion scale (PHQ-9 [9-question Patient Health Questionnaire] with scale from 0-3, lower score indicating better mental health
Measured: 48 weeks
% of participants with self-reported symptoms of anxiety at 48 weeks.
Measured through the self-completion scale GAD-7 [Generalized Anxiety Disorder 7) with scale from 0-3, lower score indicating better mental health
Measured: 48 weeks
% of participants reporting recent thoughts of or attempts at suicide at 48 weeks.
This will be taken from other studies among people who inject drugs with "suicidality" specified as recent (within last 4 weeks) thoughts of and attempts at suicide.
Measured: 48 weeks
Patient-reported outcomes using the EuroQol measures of health status
Patient-reported outcomes (PROMs) assessing health-related quality of life will include the EQ5D-5L, which measures the five dimensions of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression (range 1-5, lower score indicates better health)
Measured: 48 weeks
Patient-reported outcomes using the EuroQol visual analogue scale (EQVAS)
Patient-reported outcomes (PROMs) assessing health-related quality of life using a visual analogue scale EQVAS (range 0-100, higher score indicates better health).
Measured: 48 weeks
% of participants reporting a non-fatal overdose in the last 6 months
This will be defined as losing consciousness due to a drug-related overdose (opioids or ATS) in the last 6 months.
Measured: 48 weeks
% of participants reporting risky levels of alcohol use (range 0-12, higher score indicates higher risk alcohol use).
Self-reported alcohol use will be measured using the Alcohol Use Disorders Identification Test (AUDIT)
Measured: 48 weeks
% of participants reporting experience of Stigma and discrimination is measured through the substance use stigma mechanism scale (SU-SMS) (range 1-5, higher scores denote greater stigma and discrimination)
Stigma and discrimination will be measured using the substance use stigma mechanism scale that measures enacted and internalized stigma from family and health care workers.
Measured: 48 weeks
% of participants reporting being arrested by the police in the last 6 months measured at 48 weeks.
This is a self reported measure: "In the last 6 months, have you been arrested or detained or charged by police in (XX location) for any reason?"
Measured: 48 weeks
% of participants who have been in prison in the last 6 months measured at 48 weeks
This is a self-reported measure: "In the last 6 months, have you spent time in prison, jail or a young offenders institute?"
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start1 Nov 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 760 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Collaborators
- UNITAID, World Health Organization, Médecins du Monde, Frontline AIDS, London School of Hygiene and Tropical Medicine, International Network of People who Use Drugs, Monash University, Population Services International, Burnet Institute, University of Bristol, Alliance for the Public's Health, Coact Technical Support Limited
- Responsible party
- Sponsor
- Investigators
- Kimberly Green, Principal investigator, PATH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06129916
- Sponsor's protocol ID
- RES-00617
- Status last verified
- Oct 2025
- First submitted
- 4 Oct 2023
- Last updated
- 7 Oct 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06129916
- Acronym / sponsor ID
- RES-00617
- Conditions
- Opioid Dependence
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 760 participants (estimated)
- Lead sponsor
- PATHUniversity, hospital or other
- Collaborators
- UNITAID, World Health Organization, Médecins du Monde, Frontline AIDS, London School of Hygiene and Tropical Medicine, International Network of People who Use Drugs, Monash University, Population Services International, Burnet Institute, University of Bristol, Alliance for the Public's Health, Coact Technical Support Limited
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PWID who opt for LADB | – | Drug: long-acting depot buprenorphine (LADB)People with opioid dependence who opt to initiate LADB across a range of LMIC settings over a 48-week period |
| PWID who opt for standard of care | – | –People with opioid dependence who refuse to initiate LADB and opt for standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | PWID who opt for LADB |
Primary outcome
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
Time frame: 48 weeks
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.
Retention in Care
Time frame: 48 weeks
The primary measure for retention in care will be estimated as the proportion of people on LADB at 48 weeks
Nonmedical opioid use
Time frame: 48 weeks
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.
11 secondary outcomes
% 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
Time frame: 48 weeks
% of participants with self reported symptoms of depression at 48 weeks.
Time frame: 48 weeks
% of participants with self-reported symptoms of anxiety at 48 weeks.
Time frame: 48 weeks
% of participants reporting recent thoughts of or attempts at suicide at 48 weeks.
Time frame: 48 weeks
Patient-reported outcomes using the EuroQol measures of health status
Time frame: 48 weeks
Patient-reported outcomes using the EuroQol visual analogue scale (EQVAS)
Time frame: 48 weeks
% of participants reporting a non-fatal overdose in the last 6 months
Time frame: 48 weeks
% of participants reporting risky levels of alcohol use (range 0-12, higher score indicates higher risk alcohol use).
Time frame: 48 weeks
% of participants reporting experience of Stigma and discrimination is measured through the substance use stigma mechanism scale (SU-SMS) (range 1-5, higher scores denote greater stigma and discrimination)
Time frame: 48 weeks
% of participants reporting being arrested by the police in the last 6 months measured at 48 weeks.
Time frame: 48 weeks
% of participants who have been in prison in the last 6 months measured at 48 weeks
Time frame: 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kimberly Green principal investigator
PATH
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Dependence, run by PATH.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kimberly Green, MA, PhD (+1(202)-515-0626, kgreen@path.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 48 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.