ANZCTR - Registration

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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]

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

Opioid dependence

Condition category

Condition code

Mental Health

Addiction

Anaesthesiology

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]

Treatment: Drugs

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Patient reported pain outcomes including measures of pain severity and pain interference, measured using the Brief Pain Inventory (BPI)

Timepoint [1]

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]

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]

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]

Patient reported outcomes regarding general health and quality of life (composite score), measured using the PROMIS-29

Timepoint [2]

Baseline (4 weeks prior to transfer), and at week 4, 8, 12 after first dose of depot buprenorphine

Secondary outcome [3]

Patient satisfaction with medication, using the Treatment Satisfaction Questionnaire for Medication (TSQM)

Timepoint [3]

Baseline (4 weeks prior to transfer), and at week 4, 8, 12 following first depot buprenorphine

Secondary outcome [4]

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]

At weeks 4,8 and 12 following first dose of depot buprenorphine

Secondary outcome [5]

Use of concomitant medications for pain management, as assessed by Study Medical Officers in verbal clinical interview

Timepoint [5]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Prince of Wales Hospital - Randwick

Recruitment hospital [2]

The Langton Centre - Surry Hills

Recruitment hospital [3]

St George Hospital - Kogarah

Recruitment hospital [4]

The Sutherland Hospital - Caringbah

Recruitment postcode(s) [1]

2031 - Randwick

Recruitment postcode(s) [2]

2010 - Surry Hills

Recruitment postcode(s) [3]

2217 - Kogarah

Recruitment postcode(s) [4]

2229 - Caringbah

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Camurus AB

Address [1]

Ideon Science Park. SE-223 70 Lund, Sweden.

Country [1]

Sweden

Funding source category [2]

Government body

Name [2]

South East Sydney Local Health District

Address [2]

c/o Langton Centre, 591 South Dowling Street, Surry Hills, NSW 2010 AUSTRALIA

Country [2]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

University

Name [1]

University of Sydney

Address [1]

Camperdown NSW 2006

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South East Sydney Local Health District Human Research Ethics Committee

Ethics committee address [1]

Barker Street, Randwick, NSW, 2031

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

09/11/2021

Approval date [1]

15/03/2022

Ethics approval number [1]

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

Prof Nicholas Lintzeris

Address

c/o The Langton Centre, 591 South Dowling Street, Surry Hills, NSW 2010

Country

Australia

Phone

+61419261675

Fax

[email protected]

Contact person for public queries

Name

Nicholas Lintzeris

Address

c/o The Langton Centre, 591 South Dowling Street, Surry Hills, NSW 2010

Country

Australia

Phone

+61419261675

Fax

[email protected]

Contact person for scientific queries

Name

Nicholas Lintzeris

Address

c/o The Langton Centre, 591 South Dowling Street, Surry Hills, NSW 2010

Country

Australia

Phone

+61419261675

Fax

[email protected]

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 ([email protected])

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
15529	Study protocol	Available on request from Chief Investigator ([email protected])		[email protected]	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.

Documents added automatically

No additional documents have been identified.

Trial Review

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