Health TrialsbyHealthPanel

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

ConditionOpioid Dependence
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPATH

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

760 Participants
are divided into 2 treatment groups
Group A: PWID who opt for LADB1 intervention
Group B: PWID who opt for standard of care0 interventions

Trial outcomes

Primary outcomes

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

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.

Time frame
48 weeks
2

Retention in Care

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

Time frame
48 weeks
3

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.

Time frame
48 weeks

Secondary outcomes

1

% 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.

Time frame
48 weeks
2

% 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

Time frame
48 weeks
3

% 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

Time frame
48 weeks
4

% 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.

Time frame
48 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

PATH

Lead sponsor

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

Source ClinicalTrials.gov

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