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Trial registered on ANZCTR


Registration number
ACTRN12618000942257
Ethics application status
Approved
Date submitted
24/05/2018
Date registered
4/06/2018
Date last updated
5/06/2019
Date data sharing statement initially provided
5/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the safety and feasibility of depot buprenorphine in NSW custodial settings
Scientific title
Assessing the Safety and Feasibility of Long-Acting Depot of Buprenorphine in Adults Requiring Treatment for Opioid Use Disorder in NSW Custodial Settings
Secondary ID [1] 294987 0
DBC2531
Universal Trial Number (UTN)
U1111-1214-5974
Trial acronym
The UNLOC-T Study (Understanding NSW Long-acting Opioids in Custody- Treatment)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Opioid use disorder 308001 0
Condition category
Condition code
Mental Health 307037 307037 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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)
Intervention code [1] 301321 0
Treatment: Drugs
Comparator / control treatment
Oral methadone (Biodone Forte®, containing methadone 5mg/mL oral liquid) - doses directly observed and clinically titrated according to standard clinical practice, administered daily for four months as per standard clinical practice
Control group
Active

Outcomes
Primary outcome [1] 306013 0
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
Timepoint [1] 306013 0
1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, 12 weeks and 16 weeks (primary time point) post enrolment
Primary outcome [2] 306014 0
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)
Timepoint [2] 306014 0
4 weeks post commencement of trial
Primary outcome [3] 306015 0
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
Timepoint [3] 306015 0
4 weeks post trial commencement
Secondary outcome [1] 347311 0
Retention in treatment; Calculated as days in treatment since enrolment until the last day of
medication
Timepoint [1] 347311 0
4 weeks and 16 weeks post enrolment
Secondary outcome [2] 347312 0
Non-medical use of opioids and other drugs; Australian Treatment Outcomes Profile (ATOP)
Timepoint [2] 347312 0
Baseline, 4 weeks and 16 weeks post enrolment
Secondary outcome [3] 347313 0
Dose adequacy; Subjective Opiate Withdrawal Scale (SOWS) and Drug and Alcohol Review Form (DARF)
Timepoint [3] 347313 0
Day 1, Day 2, Week 1, Week 4 and Week 16 post enrolment
Secondary outcome [4] 347314 0
Opioid cravings; Craving visual analogue scale (Craving VAS)
Timepoint [4] 347314 0
Baseline, Week 4 and Week 16 post enrolment
Secondary outcome [5] 347315 0
Behavioural risk and health and wellbeing; ATOP, Short Form (SF-12) and Kessler 10 (K10)
Timepoint [5] 347315 0
Baseline, Week 4 and Week 16 post enrolment
Secondary outcome [6] 347316 0
Patient satisfaction and experience of treatment; Patient satisfaction with treatment (VAS 0-100), Treatment satisfaction (Treatment Satisfaction Questionnaire for Medication, TSQM), Self-reported treatment preference
Timepoint [6] 347316 0
Baseline, Week 4 and Week 16 post enrolment
Secondary outcome [7] 347524 0
Recent history of suicidal ideation or active suicidal behaviour; Columbia Suicide Severity Rating Scale (C-SSRS) and/or clinical assessment
Timepoint [7] 347524 0
Baseline, Week 4 and Week 16 post enrolment
Secondary outcome [8] 347566 0
Other occurrences of noncompliance during the dosing period e.g. Patient is abusive/threatening to nursing or custodial staff before, during or after dosing or patient spits out part / all of dose; JH&FMHN IIMS
Timepoint [8] 347566 0
4 weeks post trial commencement
Secondary outcome [9] 347592 0
Overdose; Self-reported in study-specific questionnaire
Timepoint [9] 347592 0
Baseline, Week 4 and Week 16 post enrolment
Secondary outcome [10] 347593 0
Interpersonal violence, including threats (to self and/or family and/or friends) and actual assaults related to pressure patients to divert; Self-reported in study-specific questionnaire
Timepoint [10] 347593 0
Baseline, Week 4 and Week 16 post enrolment
Secondary outcome [11] 347594 0
Non-medical use of study medications (number of times diverted and misused since last visit); Self-reported in study-specific questionnaire
Timepoint [11] 347594 0
Baseline, Week 4 and Week 16 post enrolment
Secondary outcome [12] 347595 0
Staff satisfaction with depot buprenorphine and acceptability of opioid agonist therapy generally; Focus groups with staff facilitated by researcher, recorded using a digital recorded and later transcribed and analysed using thematic analysis
Timepoint [12] 347595 0
16 weeks post trial commencement

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint(s)
Safety
Statistical methods / analysis
As a phase II/III trial designed to assess safety and feasibility in a unique setting, sufficient numbers of participants at each site are required to assess safety in a range of correctional centre types and inmate populations. Sufficient numbers per site are also required to obtain meaningful information about service impacts. To ensure sufficient data is collected for safety analysis participants who do not complete the protocol will be replaced.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 299573 0
Government body
Name [1] 299573 0
NSW Ministry of Health
Address [1] 299573 0
73 Miller St, North Sydney NSW 2060
Country [1] 299573 0
Australia
Primary sponsor type
Government body
Name
NSW Ministry of Health
Address
73 Miller St, North Sydney NSW 2060
Country
Australia
Secondary sponsor category [1] 298884 0
Government body
Name [1] 298884 0
Drug and Alcohol Services, Hunter New England Local Health District
Address [1] 298884 0
Newcastle Community Health Centre, Suite 8, Level 3, 670 Hunter St, NEWCASTLE 2300, NSW
Country [1] 298884 0
Australia
Secondary sponsor category [2] 298887 0
Government body
Name [2] 298887 0
Drug Health Services, Sydney Local Health District
Address [2] 298887 0
Level 6, KGV Building, Missenden Rd Camperdown NSW 2050
Country [2] 298887 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300472 0
Justice Health & Forensic Mental Health Network HREC
Ethics committee address [1] 300472 0
PO Box 150 Matraville NSW 2036
Ethics committee country [1] 300472 0
Australia
Date submitted for ethics approval [1] 300472 0
15/02/2018
Approval date [1] 300472 0
20/04/2018
Ethics approval number [1] 300472 0
JH File No G561/17
Ethics committee name [2] 300474 0
Aboriginal Health & Medical Research Council HREC
Ethics committee address [2] 300474 0
66 Wentworth Ave, Surry Hills NSW 2010
Ethics committee country [2] 300474 0
Australia
Date submitted for ethics approval [2] 300474 0
01/03/2018
Approval date [2] 300474 0
26/04/2018
Ethics approval number [2] 300474 0
1379/18
Ethics committee name [3] 300475 0
Corrective Services Ethics Committee
Ethics committee address [3] 300475 0
Level 5 Henry Deane Building, 20 Lee Street Sydney NSW 2001
Ethics committee country [3] 300475 0
Australia
Date submitted for ethics approval [3] 300475 0
09/02/2018
Approval date [3] 300475 0
14/03/2018
Ethics approval number [3] 300475 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83770 0
Prof Adrian Dunlop
Address 83770 0
Drug and Alcohol Services, Hunter New England Local Health District
Newcastle Community Health Centre
Suite 8, Level 3, 670 Hunter St, NEWCASTLE 2300,
Country 83770 0
Australia
Phone 83770 0
+61 2 40164664
Fax 83770 0
Email 83770 0
Adrian.Dunlop@hnehealth.nsw.gov.au
Contact person for public queries
Name 83771 0
Dr Bethany White
Address 83771 0
Drug Health Services, Sydney Local Health District
Level 6, KGV Building, Missenden Road
Camperdown NSW 2050
Country 83771 0
Australia
Phone 83771 0
+61 2 9515 6407
Fax 83771 0
Email 83771 0
bethany.white@sydney.edu.au
Contact person for scientific queries
Name 83772 0
Prof Adrian Dunlop
Address 83772 0
Drug and Alcohol Services, Hunter New England Local Health District
Newcastle Community Health Centre
Suite 8, Level 3, 670 Hunter St, NEWCASTLE 2300,
Country 83772 0
Australia
Phone 83772 0
+61 2 40164664
Fax 83772 0
Email 83772 0
Adrian.Dunlop@hnehealth.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Implications not yet considered, will discuss with our Protocol Steering Committee and update response if required in due course
What supporting documents are/will be available?
No other documents available
Summary results
No Results