Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03809143
Registration number
NCT03809143
Ethics application status
Date submitted
16/01/2019
Date registered
18/01/2019
Titles & IDs
Public title
Community Studies of Long Acting Buprenorphine (CoLAB)
Query!
Scientific title
An Open-label, Multicentre, Single-arm Trial of Monthly Injections of Depot Buprenorphine in People With Opioid Dependence
Query!
Secondary ID [1]
0
0
CoLAB1801
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
CoLAB
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Opioid Dependence
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Participant retention
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Retention in dosing schedule at 48 weeks
Query!
Secondary outcome [1]
0
0
BUP-XR treatment retention and engagement in ongoing clinical care
Query!
Assessment method [1]
0
0
To examine BUP-XR treatment retention and engagement in ongoing clinical care at 48 weeks ortion of participants retained in treatment at 48 weeks following initiation of monthly depot buprenorphine injections and engaged in ongoing clinical care. Treatment retention is defined as remaining on active depot buprenorphine medication AND completing a clinical assessment at 48 weeks.
Query!
Timepoint [1]
0
0
48 weeks
Query!
Secondary outcome [2]
0
0
Changes in opioid withdrawal
Query!
Assessment method [2]
0
0
Change in opioid withdrawal assessed by clinical opioid withdrawal scale (COWS) and subjective opioid withdrawal scale (SOWS)
Query!
Timepoint [2]
0
0
48 weeks
Query!
Secondary outcome [3]
0
0
Changes in client-reported opioid craving
Query!
Assessment method [3]
0
0
Change in client-reported opioid craving assessed by opioid craving scale
Query!
Timepoint [3]
0
0
48 weeks
Query!
Secondary outcome [4]
0
0
Changes in client-reported drug use
Query!
Assessment method [4]
0
0
Change in client-reported use of opioids and other drugs, assessed by the Australian Treatment Outcomes Profile (ATOP) instrument
Query!
Timepoint [4]
0
0
48 weeks
Query!
Secondary outcome [5]
0
0
BUP-XR dosing schedule adherence
Query!
Assessment method [5]
0
0
To evaluate client utilisation of buprenorphine medication during the study, including BUP-XR dose variation, adherence with dosing schedule, and dose supplementation
Query!
Timepoint [5]
0
0
48 weeks
Query!
Secondary outcome [6]
0
0
BUP-XR safety and tolerability
Query!
Assessment method [6]
0
0
To evaluate treatment safety and tolerability by monitoring adverse events, and events of clinical interest such as drug-drug interactions and pain management in clients treated with BUP-XR
Query!
Timepoint [6]
0
0
48 weeks
Query!
Secondary outcome [7]
0
0
Changes in client-report pain and enjoyment
Query!
Assessment method [7]
0
0
To describe client-reported changes to pain and enjoyment of life, assessed by the Pain, Enjoyment, General Activity (PEG) scale
Query!
Timepoint [7]
0
0
48 weeks
Query!
Secondary outcome [8]
0
0
Demographic factors associated with treatment retention
Query!
Assessment method [8]
0
0
To evaluate demographic factors (gender, age, education) associated with treatment retention, assessed by demographic questionnaire
Query!
Timepoint [8]
0
0
48 weeks
Query!
Secondary outcome [9]
0
0
Client treatment satisfaction score
Query!
Assessment method [9]
0
0
Client-reported treatment satisfaction assessed by the Treatment Questionnaire for Medication Satisfaction (TQSM)
Query!
Timepoint [9]
0
0
48 weeks
Query!
Secondary outcome [10]
0
0
BUP-XR treatment costs
Query!
Assessment method [10]
0
0
Costs to services delivering BUP-XR assessed by site-reported expenses and time and motion study
Query!
Timepoint [10]
0
0
48 weeks
Query!
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)
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
65
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Other
Query!
Allocation to intervention
NA
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
UNKNOWN
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
22/05/2019
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
30/03/2021
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
100
Query!
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Query!
Recruitment hospital [1]
0
0
Drug and Alcohol Services, Hunter New England Local Health District - Newcastle
Query!
Recruitment hospital [2]
0
0
Drug and Alcohol Services, North Sydney Local Health District - Saint Leonards
Query!
Recruitment hospital [3]
0
0
Drug and Alcohol Services, South Australia (DASSA) - Morphett Vale
Query!
Recruitment hospital [4]
0
0
Western Health Drug Services, Footscray Hospital - Footscray
Query!
Recruitment hospital [5]
0
0
Frankston Healthcare - Frankston
Query!
Recruitment hospital [6]
0
0
Rankin Court Treatment Centre, St Vincent's Hospital Sydney - Darlinghurst
Query!
Recruitment postcode(s) [1]
0
0
2300 - Newcastle
Query!
Recruitment postcode(s) [2]
0
0
2065 - Saint Leonards
Query!
Recruitment postcode(s) [3]
0
0
5162 - Morphett Vale
Query!
Recruitment postcode(s) [4]
0
0
3011 - Footscray
Query!
Recruitment postcode(s) [5]
0
0
3199 - Frankston
Query!
Recruitment postcode(s) [6]
0
0
2010 - Darlinghurst
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
The University of New South Wales
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT03809143
Query!
Trial related presentations / publications
Farrell M, Shahbazi J, Byrne M, Grebely J, Lintzeris N, Chambers M, Larance B, Ali R, Nielsen S, Dunlop A, Dore GJ, McDonough M, Montebello M, Nicholas T, Weiss R, Rodgers C, Cook J, Degenhardt L; CoLAB study team. Outcomes of a single-arm implementation trial of extended-release subcutaneous buprenorphine depot injections in people with opioid dependence. Int J Drug Policy. 2022 Feb;100:103492. doi: 10.1016/j.drugpo.2021.103492. Epub 2021 Nov 1. Larance B, Byrne M, Lintzeris N, Nielsen S, Grebely J, Degenhardt L, Shahbazi J, Shanahan M, Lancaster K, Dore G, Ali R, Farrell M; CoLAB study team. Open-label, multicentre, single-arm trial of monthly injections of depot buprenorphine in people with opioid dependence: protocol for the CoLAB study. BMJ Open. 2020 Jul 31;10(7):e034389. doi: 10.1136/bmjopen-2019-034389.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Michael Farrell
Query!
Address
0
0
National Drug and Alcohol Centre, University of New South Wales
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03809143