None listed
Conditions
Brief summary
This four-month trial will compare long-acting depot buprenorphine (CAM2038) to standard of care (oral methadone) in adult males and females in custody with opioid use disorder to identify any unexpected safety and tolerability considerations specific to the adult custodial population in NSW. Analysis of routinely collected data will examine clinic-based diversion (or attempted diversion) among all inmates receiving opioid agonist therapy (depot buprenorphine, sublingual buprenorphine- naloxone film and oral methadone) as well as violent misconduct and involvement in assaults at each site and among trial participants. Further, a cost-consequence study will be undertaken to compare the costs and consequences of dosing activity recorded for all treatment types for both JH&FMHN clinical practice and CSNSW officer time. Finally, focus groups with CSNSW and JH&FMHN staff will be conducted to assess staff satisfaction and acceptability of OAT and related issues.
Interventions
CAM2038 50 mg/mL once-weekly (Buprenorphine FluidCrystal® subcutaneous injection depot) - administered weekly for one month by a trained clinician (medical practitioner or registered nurse)
CAM2038 356 mg/mL once-monthly (Buprenorphine FluidCrystal® subcutaneous injection depot) - administered monthly for at least three months and up to 12 months by a trained clinician (medical practitioner or registered nurse)
Sponsors
NSW Ministry of Health
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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)
Outcome results
None listed