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Trial registered on ANZCTR


Registration number
ACTRN12622000511730
Ethics application status
Approved
Date submitted
23/03/2022
Date registered
31/03/2022
Date last updated
31/03/2022
Date data sharing statement initially provided
31/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Case series examining the use of depot buprenorphine formulation Buvidal® in the management of patients with co-occurring opioid dependence and chronic pain
Scientific title
Case series examining the use of depot buprenorphine formulation Buvidal® in the management of patients with co-occurring opioid dependence and chronic pain
Secondary ID [1] 306751 0
DAS-21-2
Universal Trial Number (UTN)
U1111-1276-2219
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic pain 325757 0
Opioid dependence 325758 0
Condition category
Condition code
Mental Health 323097 323097 0 0
Addiction
Anaesthesiology 323168 323168 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study involves the administration of depot buprenorphine subcutaneous injections to opioid dependent patients with concurrent chronic pain, and monitoring of a range of health outcomes and patient satisfaction measures over a 12 week treatment period following the first dose.

The dose of depot buprenorphine will be individualised, ranging from 8, 16, 24 or 32mg Weekly doses and/or 64, 96, 128 or 160mg Monthly doses. Doses will be titrated according to dose and type of opioid medication from which the patient is transferring from. Participants will be transferring from either sublingual buprenorphine, oral methadone or oral opioid anaglesics (e.g. oxycodone, morphine), and the dose of depot buprenorphine will be determined according to NSW Health Clinical Guidelines on the use of depot buprenorphine (2019).

Depot buprenorphine doses will be continued for the duration of the study - 12 weeks, with the expectation that participants will be routinely treated with Monthly doses, although Weekly doses may be used in the first 1-4 weeks following transfer from other opioid medications.

Participants will be reviewed by Addiction Medicine specialists at a minimum of 4 weekly appointments over the 12 week period. These will routinely be conducted face to face, however may be conducted by telehealth due to travel and/or social isolation restrictions. Participants will receive depot buprenorphine injections by Drug and Alcohol nursing staff at participating sites - namely public sector specialist outpatient alcohol and drug treatment services.

All medications are administered at the participating sites, enabling adherence to be monitored.
Intervention code [1] 323199 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330863 0
Patient reported pain outcomes including measures of pain severity and pain interference, measured using the Brief Pain Inventory (BPI)
Timepoint [1] 330863 0
Captured at baseline (in 4 weeks prior to transfer to depot buprenorphine), and at 4, 8 and 12 (primary timepoint) weeks following the first dose of depot buprenorphine
Secondary outcome [1] 407873 0
Patient reported substance use (days used in past 28 days for each of following substances: alcohol, cannabis, unsanctioned opioids, amphetamines, cocaine, benzodiazepines, tobacco). Measured using the Australian Treatment Outcome Profile (ATOP)
Timepoint [1] 407873 0
Measured at baseline (in 4 weeks prior to transfer), at week 4, week 8 and week 12 after first dose of depot buprenorphine.
Secondary outcome [2] 407874 0
Patient reported outcomes regarding general health and quality of life (composite score), measured using the PROMIS-29
Timepoint [2] 407874 0
Baseline (4 weeks prior to transfer), and at week 4, 8, 12 after first dose of depot buprenorphine
Secondary outcome [3] 407875 0
Patient satisfaction with medication, using the Treatment Satisfaction Questionnaire for Medication (TSQM)
Timepoint [3] 407875 0
Baseline (4 weeks prior to transfer), and at week 4, 8, 12 following first depot buprenorphine
Secondary outcome [4] 407876 0
Adverse events, assessed by Study Medical Officers in clinical face to face interview (and examination as appropriate), and using Common Terminology Criteria for Adverse Events (CTCAE4)
Timepoint [4] 407876 0
At weeks 4,8 and 12 following first dose of depot buprenorphine
Secondary outcome [5] 407877 0
Use of concomitant medications for pain management, as assessed by Study Medical Officers in verbal clinical interview
Timepoint [5] 407877 0
Baseline, weeks 4,8,12 after first dose depot buprenorphine

Eligibility
Key inclusion criteria
Patients treated in participating services with (a) co-existing chronic pain; defined as persistent or recurring pain lasting longer than 3 months and (b) a history of opiate dependence, and (c) who transfer from an opioid medication (e.g. opioid analgesics, methadone, sublingual buprenorphine) to depot buprenorphine medication using the formulation Buvidal®.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusions include people under the age of 18, those with acute and/or severe health conditions requiring immediate treatment, pregnancy or breastfeeding.

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)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Random slopes mixed-effects models for repeated measures regressions will be used to estimate change in outcome measures: Gaussian regression with identity link function for continuous measures (ATOP, BPI, TSQM, PROMIS-29), binomial regression with logit link function for dichotomous measures, and negative binomial regression with log link function for count measures (e.g. Adverse events)

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/04/2022
Actual
Date of last participant enrolment
Anticipated
17/04/2023
Actual
Date of last data collection
Anticipated
12/07/2023
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 22011 0
Prince of Wales Hospital - Randwick
Recruitment hospital [2] 22012 0
The Langton Centre - Surry Hills
Recruitment hospital [3] 22013 0
St George Hospital - Kogarah
Recruitment hospital [4] 22014 0
The Sutherland Hospital - Caringbah
Recruitment postcode(s) [1] 37130 0
2010 - Surry Hills
Recruitment postcode(s) [2] 37129 0
2031 - Randwick
Recruitment postcode(s) [3] 37131 0
2217 - Kogarah
Recruitment postcode(s) [4] 37132 0
2229 - Caringbah

Funding & Sponsors
Funding source category [1] 311089 0
Commercial sector/Industry
Name [1] 311089 0
Camurus AB
Country [1] 311089 0
Sweden
Funding source category [2] 311090 0
Government body
Name [2] 311090 0
South East Sydney Local Health District
Country [2] 311090 0
Australia
Primary sponsor type
Government body
Name
South East Sydney Local Health District
Address
Barker Street, Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 312419 0
None
Name [1] 312419 0
Address [1] 312419 0
Country [1] 312419 0
Other collaborator category [1] 282228 0
University
Name [1] 282228 0
University of Sydney
Address [1] 282228 0
Camperdown NSW 2006
Country [1] 282228 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310624 0
South East Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 310624 0
Barker Street, Randwick, NSW, 2031
Ethics committee country [1] 310624 0
Australia
Date submitted for ethics approval [1] 310624 0
09/11/2021
Approval date [1] 310624 0
15/03/2022
Ethics approval number [1] 310624 0
2021/ETH12374

Summary
Brief summary
The study examines patient outcomes and experiences in the use of depot buprenorphine formulation (Buvidal) in the treatment of patients with concurrent opioid dependence and chronic pain conditions using a prospective case series. Specifically the study will compare outcomes and experiences of patients before and after transfer from other opioid medications to Buvidal® treatment on the following measures:
1. Patient reported pain outcomes including measures of pain severity and pain interference using the Brief Pain Inventory (primary outcome);
2. Secondary outcomes include patient reported substance use (ATOP), general health and quality of life outcomes (PROMIS-29), adverse events, and patient satisfaction measures (TSQM), and use of other medications for pain management.
These outcomes will be examined at baseline (in period before transferring to depot buprenorphine), and at 4 weekly intervals for 12 weeks following the first dose of depot buprenorphine, during which depot treatment will be continued.

A prospective case series of patients treated in South East Sydney Local Health District Drug and Alcohol Services and Prince of Wales Hospital Department of Pain Management.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118302 0
Prof Nicholas Lintzeris
Address 118302 0
c/o The Langton Centre, 591 South Dowling Street, Surry Hills, NSW 2010
Country 118302 0
Australia
Phone 118302 0
+61419261675
Fax 118302 0
Email 118302 0
Nicholas.Lintzeris@health.nsw.gov.au
Contact person for public queries
Name 118303 0
Prof Nicholas Lintzeris
Address 118303 0
c/o The Langton Centre, 591 South Dowling Street, Surry Hills, NSW 2010
Country 118303 0
Australia
Phone 118303 0
+61419261675
Fax 118303 0
Email 118303 0
Nicholas.Lintzeris@health.nsw.gov.au
Contact person for scientific queries
Name 118304 0
Prof Nicholas Lintzeris
Address 118304 0
c/o The Langton Centre, 591 South Dowling Street, Surry Hills, NSW 2010
Country 118304 0
Australia
Phone 118304 0
+61419261675
Fax 118304 0
Email 118304 0
Nicholas.Lintzeris@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified data regarding participant demographics, outcomes measures and medication details
When will data be available (start and end dates)?
June 2023 to June 2028
Available to whom?
To researchers who provide a methodologically sound proposal, assessed case-by-case basis by the Chief Investigator
Available for what types of analyses?
For meta-analysis as defined in a methodologically sound proposal
How or where can data be obtained?
By contacting the Chief Investigator (nicholas.lintzeris@health.nsw.gov.au)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15529Study protocolAvailable on request from Chief Investigator (nicholas.lintzeris@health.nsw.gov.au) Nicholas.Lintzeris@health.nsw.gov.au Available on request from Chief Investigator (nich... [More Details]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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