Assessing the safety and feasibility of depot buprenorphine in NSW custodial settings

Phase 2

Completed

• Conditions: Opioid use disorder; Mental Health - Addiction

• Registration Number: ACTRN12618000942257
• Lead Sponsor: SW Ministry of Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-04
• Study Completion: 2019-11-21
• Last Update Posted: 17 August 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

1. Adult male and female prisoners (aged 18 years or older) sentenced in full-time custody
2. Demonstrating sufficient English language ability and willing to provide written informed consent
3. Sentenced for all charges, with at least six months remaining on sentence
4. Willing and able to comply with requirements of the study
5. Meets the criteria for opioid dependence as defined by Diagnostic and Statistical Manual of Mental Disorders – 5th Edition (DSM-5) for moderate to severe opioid use disorder
6. Appropriate candidate for medically assisted treatment with partial/full opioid agonist treatment as determined by the Principal Investigator

Exclusion Criteria

1. General clinical contraindications for partial/full opioid agonist treatment (see National Guidelines for Medication-Assisted Treatment of Opioid Dependence, 2014)
2. Current, severe medical condition (e.g. hepatic failure or respiratory insufficiency) assessed by Principal Investigator
3. Any known hypersensitivity to methadone or buprenorphine
4. Participants with a serious untreated psychiatric comorbidity at the discretion of the Principal Investigator
5. Recent history of suicidal ideation or active suicidal behaviour as based on the Columbia Suicide Severity Rating Scale (C-SSRS) and/or clinical assessment
6. Forensic mental health patient not guilty by reason of mental illness
7. Clinically significant laboratory abnormalities, which in the opinion of the Investigator may prevent the patient from safely participating in trial
8. History of risk factors of Torsades de Pointes heart arrhythmia (e.g., heart failure, hypokalemia, family history of long QT syndrome) or an electrocardiogram (ECG) demonstrating a clinically significant abnormality, as judged by the Investigator
9. Requires chronic use of agents that are strong inhibitors or inducers of cytochrome P450 3A4 (CYP 3A4) such as some azole antifungals (e.g. ketoconazole), macrolide antibiotics (e.g. clarithromycin), or protease inhibitors (e.g. ritonavir, indinavir, and saquinavir) or other inducers (e.g. phenobarbital, carbamazepine, phenytoin and rifampicin)
10. Benzodiazepine use disorder based on clinical assessment
11. Currently breastfeeding or pregnant
12. Patients who have had an investigational new drug or device within the last 30 days
13. Patient is on his/her parole period (past earliest date of release)
14. Patient is enrolled in a residential or intensive treatment program (Intensive Drug Treatment Program, Intensive Sex Offender Treatment Program, Compulsory Drug Treatment Program and Drug Court Program)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse events (AEs) e.g. headache or nausea and serious adverse events (SAEs) e.g. moderate to severe vomiting; Clinically assessed and reviewed by the principal investigator [1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, 12 weeks and 16 weeks (primary time point) post enrolment];Incidents of diversion during the dosing period e.g. nursing staff observe patient remove tablet/part of tablet/film from his/her mouth; JH&FMHN Incident Information Management System (IIMS)<br>[4 weeks post commencement of trial ];Total time taken to administer dose, including supervision time post-dose administration and time taken to transfer prisoners to and from the clinic for treatment; Observed and timed by researchers[4 weeks post trial commencement]