Back to resultsCommunity Studies of Long Acting Buprenorphine (CoLAB) (CoLAB)
Primary Purpose
Opioid Dependence
Status
Unknown status
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
RBP-6000
Sponsored by
About this trial
This is an interventional health services research trial for Opioid Dependence
Eligibility 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:
- Voluntarily signed the informed consent form
- Aged 18 to 65 years
- Opioid-dependent (ICD-10) currently receiving treatment
- Has been receiving 8-32mg sublingual buprenorphine +/- naloxone tablets/film for at least 7 days
- 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)
Exclusion criteria
Participants who meet any of the exclusion criteria are not to be enrolled in this study:
- Currently lactating or pregnant, or of childbearing potential and not willing to avoid becoming pregnant during the study
- History or presence of allergic or adverse response (including rash or anaphylaxis) to buprenorphine or the ATRIGEL® Delivery System
- 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)
- Subjects who are currently participating in any other clinical study involving investigational medication(s)
- Inability or unwillingness to provide informed consent or abide by the requirements of the study
Sites / Locations
- Drug and Alcohol Services, Hunter New England Local Health District
- Drug and Alcohol Services, North Sydney Local Health District
- Drug and Alcohol Services, South Australia (DASSA)
- Western Health Drug Services, Footscray Hospital
- Frankston Healthcare
- Rankin Court Treatment Centre, St Vincent's Hospital Sydney
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Depot buprenorphine arm
Arm Description
All participants will receive monthly injections of depot buprenorphine (RBP-6000, Sublocade)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
BUP-XR treatment retention and engagement in ongoing clinical care
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.
Changes in opioid withdrawal
Change in opioid withdrawal assessed by clinical opioid withdrawal scale (COWS) and subjective opioid withdrawal scale (SOWS)
Changes in client-reported opioid craving
Change in client-reported opioid craving assessed by opioid craving scale
Changes in client-reported drug use
Change in client-reported use of opioids and other drugs, assessed by the Australian Treatment Outcomes Profile (ATOP) instrument
BUP-XR dosing schedule adherence
To evaluate client utilisation of buprenorphine medication during the study, including BUP-XR dose variation, adherence with dosing schedule, and dose supplementation
BUP-XR safety and tolerability
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
Changes in client-report pain and enjoyment
To describe client-reported changes to pain and enjoyment of life, assessed by the Pain, Enjoyment, General Activity (PEG) scale
Demographic factors associated with treatment retention
To evaluate demographic factors (gender, age, education) associated with treatment retention, assessed by demographic questionnaire
Client treatment satisfaction score
Client-reported treatment satisfaction assessed by the Treatment Questionnaire for Medication Satisfaction (TQSM)
BUP-XR treatment costs
Costs to services delivering BUP-XR assessed by site-reported expenses and time and motion study
Full Information
NCT ID
NCT03809143
First Posted
January 16, 2019
Last Updated
March 2, 2020
Sponsor
The University of New South Wales
1. Study Identification
Unique Protocol Identification Number
NCT03809143
Brief Title
Community Studies of Long Acting Buprenorphine (CoLAB)
Acronym
CoLAB
Official Title
An Open-label, Multicentre, Single-arm Trial of Monthly Injections of Depot Buprenorphine in People With Opioid Dependence
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 22, 2019 (Actual)
Primary Completion Date
November 1, 2020 (Anticipated)
Study Completion Date
March 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of New South Wales
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Opioid agonist treatment (OAT) is effective for opioid dependence and newer extended-release buprenorphine (BUP-XR) injections represent a significant development. The Community Long-Acting Buprenorphine (CoLAB) study aims to evaluate client outcomes among people with opioid dependence receiving 48 weeks of BUP-XR treatment, and examines the implementation of BUP-XR in diverse community healthcare settings in Australia.
The CoLAB study is a prospective single-arm, multicentre, open-label trial of monthly BUP-XR injections in people with opioid dependence. Participants are being recruited from a network of general practitioner and specialist drug treatment services located in the states of New South Wales, Victoria and South Australia in Australia. Following a minimum 7 days on 8-32mg of sublingual buprenorphine (+/- naloxone), participants will receive monthly subcutaneous BUP-XR injections administered by a healthcare practitioner at intervals of 28 days (-2/+14 days). The primary endpoint is participant retention in treatment at 48 weeks after treatment initiation. Secondary endpoints will evaluate dosing schedule variations, craving, withdrawal, substance use, health and well-being, and client-reported treatment experience. Qualitative and costing sub-studies will examine implementation barriers and facilitators at the client and provider level.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Dependence
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Depot buprenorphine arm
Arm Type
Experimental
Arm Description
All participants will receive monthly injections of depot buprenorphine (RBP-6000, Sublocade)
Intervention Type
Drug
Intervention Name(s)
RBP-6000
Other Intervention Name(s)
Sublocade
Intervention Description
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.
Primary Outcome Measure Information:
Title
Participant retention
Description
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.
Time Frame
Retention in dosing schedule at 48 weeks
Secondary Outcome Measure Information:
Title
BUP-XR treatment retention and engagement in ongoing clinical care
Description
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.
Time Frame
48 weeks
Title
Changes in opioid withdrawal
Description
Change in opioid withdrawal assessed by clinical opioid withdrawal scale (COWS) and subjective opioid withdrawal scale (SOWS)
Time Frame
48 weeks
Title
Changes in client-reported opioid craving
Description
Change in client-reported opioid craving assessed by opioid craving scale
Time Frame
48 weeks
Title
Changes in client-reported drug use
Description
Change in client-reported use of opioids and other drugs, assessed by the Australian Treatment Outcomes Profile (ATOP) instrument
Time Frame
48 weeks
Title
BUP-XR dosing schedule adherence
Description
To evaluate client utilisation of buprenorphine medication during the study, including BUP-XR dose variation, adherence with dosing schedule, and dose supplementation
Time Frame
48 weeks
Title
BUP-XR safety and tolerability
Description
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
Time Frame
48 weeks
Title
Changes in client-report pain and enjoyment
Description
To describe client-reported changes to pain and enjoyment of life, assessed by the Pain, Enjoyment, General Activity (PEG) scale
Time Frame
48 weeks
Title
Demographic factors associated with treatment retention
Description
To evaluate demographic factors (gender, age, education) associated with treatment retention, assessed by demographic questionnaire
Time Frame
48 weeks
Title
Client treatment satisfaction score
Description
Client-reported treatment satisfaction assessed by the Treatment Questionnaire for Medication Satisfaction (TQSM)
Time Frame
48 weeks
Title
BUP-XR treatment costs
Description
Costs to services delivering BUP-XR assessed by site-reported expenses and time and motion study
Time Frame
48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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:
Voluntarily signed the informed consent form
Aged 18 to 65 years
Opioid-dependent (ICD-10) currently receiving treatment
Has been receiving 8-32mg sublingual buprenorphine +/- naloxone tablets/film for at least 7 days
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)
Exclusion criteria
Participants who meet any of the exclusion criteria are not to be enrolled in this study:
Currently lactating or pregnant, or of childbearing potential and not willing to avoid becoming pregnant during the study
History or presence of allergic or adverse response (including rash or anaphylaxis) to buprenorphine or the ATRIGEL® Delivery System
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)
Subjects who are currently participating in any other clinical study involving investigational medication(s)
Inability or unwillingness to provide informed consent or abide by the requirements of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Farrell
Organizational Affiliation
National Drug and Alcohol Centre, University of New South Wales
Official's Role
Principal Investigator
Facility Information:
Facility Name
Drug and Alcohol Services, Hunter New England Local Health District
City
Newcastle
State/Province
New South Wales
ZIP/Postal Code
2300
Country
Australia
Facility Name
Drug and Alcohol Services, North Sydney Local Health District
City
Saint Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Drug and Alcohol Services, South Australia (DASSA)
City
Morphett Vale
State/Province
South Australia
ZIP/Postal Code
5162
Country
Australia
Facility Name
Western Health Drug Services, Footscray Hospital
City
Footscray
State/Province
Victoria
ZIP/Postal Code
3011
Country
Australia
Facility Name
Frankston Healthcare
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
Rankin Court Treatment Centre, St Vincent's Hospital Sydney
City
Darlinghurst
ZIP/Postal Code
2010
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34736130
Citation
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.
Results Reference
derived
PubMed Identifier
32737087
Citation
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.
Results Reference
derived
Learn more about this trial
Community Studies of Long Acting Buprenorphine (CoLAB)
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