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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03809143




Registration number
NCT03809143
Ethics application status
Date submitted
16/01/2019
Date registered
18/01/2019
Date last updated
1/08/2019

Titles & IDs
Public title
An Open-label, Multicentre, Single-arm Trial of Monthly Injections of Depot Buprenorphine in People With Opioid Dependence
Scientific title
An Open-label, Multicentre, Single-arm Trial of Monthly Injections of Depot Buprenorphine in People With Opioid Dependence
Secondary ID [1] 0 0
CoLAB1801
Universal Trial Number (UTN)
Trial acronym
CoLAB
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Opioid Dependence 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - RBP-6000

Experimental: Depot buprenorphine arm - All participants will receive monthly injections of depot buprenorphine (RBP-6000, Sublocade)


Treatment: Drugs: RBP-6000
All study participants are scheduled to receive monthly subcutaneous injections of depot BPN, RBP-6000. RBP-6000 (BPN in the ATRIGEL® Delivery System) contains buprenorphine (200mg/mL) in the ATRIGEL® Delivery System, which provides sustained plasma level of BPN over a minimum of 28 days.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Participant retention - To examine treatment retention at 48 weeks following initiation of monthly depot RBP-6000 buprenorphine injections in patients with opioid dependence transferred from a stable dose of sublingual buprenorphine.
Timepoint [1] 0 0
Retention in dosing schedule at 48 weeks

Eligibility
Key inclusion criteria
The study population is individuals diagnosed with opioid dependence who are currently
receiving sublingual buprenorphine treatment at participating drug and alcohol services,
express interest in receiving depot buprenorphine injections and are deemed suitable for
treatment with RBP-6000 by the Investigator.

Inclusion criteria

To be eligible for the study, participants must meet all of the following inclusion
criteria:

1. Voluntarily signed the informed consent form

2. Aged 18 to 65 years

3. Opioid-dependent (ICD-10) currently receiving treatment

4. Has been receiving 8-32mg sublingual buprenorphine +/- naloxone tablets/film for at
least 7 days

5. Negative pregnancy test at screening and baseline in females of childbearing potential
(please refer to Section 5.7 for long acting reversible contraceptive methods with
efficacy considered to reasonably eliminate pregnancy potential)
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria

Participants who meet any of the exclusion criteria are not to be enrolled in this study:

1. Currently lactating or pregnant, or of childbearing potential and not willing to avoid
becoming pregnant during the study

2. History or presence of allergic or adverse response (including rash or anaphylaxis) to
buprenorphine or the ATRIGEL® Delivery System

3. Significant, medical or psychiatric conditions (other than opioid dependence), or
other circumstances which, in the opinion of the Investigator, would compromise
compliance with the protocol and/or patient safety. Specific conditions of interest
include severe hepatic disease (Child-Pugh Class B), severe renal or respiratory
disease, or severe cognitive impairment or psychiatric condition that impairs the
ability to provide informed consent (e.g. psychosis, delirium, hypomania, severe
depression or suicidal ideation)

4. Subjects who are currently participating in any other clinical study involving
investigational medication(s)

5. Inability or unwillingness to provide informed consent or abide by the requirements of
the study

Study design
Purpose of the study
Health Services Research
Allocation to intervention
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
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
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,SA,VIC
Recruitment hospital [1] 0 0
Drug and Alcohol Services, Hunter New England Local Health District - Newcastle
Recruitment hospital [2] 0 0
Drug and Alcohol Services, North Sydney Local Health District - Saint Leonards
Recruitment hospital [3] 0 0
Drug and Alcohol Services, South Australia (DASSA) - Morphett Vale
Recruitment hospital [4] 0 0
Meadows Medical Centre - Altona Meadows
Recruitment hospital [5] 0 0
Western Health Drug Services, Footscray Hospital - Footscray
Recruitment hospital [6] 0 0
Frankston Healthcare - Frankston
Recruitment hospital [7] 0 0
Rankin Court Treatment Centre, St Vincent's Hospital Sydney - Darlinghurst
Recruitment postcode(s) [1] 0 0
2300 - Newcastle
Recruitment postcode(s) [2] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [3] 0 0
5162 - Morphett Vale
Recruitment postcode(s) [4] 0 0
3028 - Altona Meadows
Recruitment postcode(s) [5] 0 0
3011 - Footscray
Recruitment postcode(s) [6] 0 0
3199 - Frankston
Recruitment postcode(s) [7] 0 0
2010 - Darlinghurst

Funding & Sponsors
Primary sponsor type
Other
Name
The University of New South Wales
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Despite research demonstrating the efficacy of buprenorphine (BPN), effectiveness in
real-world settings has been limited by shorter retention than for methadone, and the need
for daily or near-daily dosing (frequently supervised in Australia). Newly developed
sustained-release BPN formulations could provide rapid onset and sustained release of BPN.

Current formulations include six-monthly implants, and once-weekly or once-monthly
injections, removing the need for frequent clinic or pharmacy attendance. Improved medication
adherence may result in improved patient outcomes and fewer unintended consequences such as
diversion, but more data are needed in real-world settings. These innovations have the
potential to dramatically change the treatment settings and options for people who are opioid
dependent.

The study aims to evaluate the patient outcomes following the implementation of a monthly BPN
depot injection for the treatment of opioid dependence in community-based treatment settings
with a focus on opioid and other illicit drug use, adherence and retention, and participants'
experiences of the implementation.
Trial website
https://clinicaltrials.gov/show/NCT03809143
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Farrell
Address 0 0
National Drug and Alcohol Centre, University of New South Wales
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Marianne Byrne
Address 0 0
Country 0 0
Phone 0 0
02 9385 9984
Fax 0 0
Email 0 0
mbyrne@Kirby.unsw.edu.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03809143