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出境医 / 临床实验 / Community Studies of Long Acting Buprenorphine (CoLAB) (CoLAB)

Community Studies of Long Acting Buprenorphine (CoLAB) (CoLAB)

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.


Condition or disease Intervention/treatment Phase
Opioid Dependence Drug: RBP-6000 Phase 3

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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: An Open-label, Multicentre, Single-arm Trial of Monthly Injections of Depot Buprenorphine in People With Opioid Dependence
Actual Study Start Date : May 22, 2019
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : March 30, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Depot buprenorphine arm
All participants will receive monthly injections of depot buprenorphine (RBP-6000, Sublocade)
Drug: 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.
Other Name: Sublocade

Outcome Measures
Primary Outcome Measures :
  1. Participant retention [ Time Frame: Retention in dosing schedule at 48 weeks ]
    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 :
  1. BUP-XR treatment retention and engagement in ongoing clinical care [ Time Frame: 48 weeks ]
    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.

  2. Changes in opioid withdrawal [ Time Frame: 48 weeks ]
    Change in opioid withdrawal assessed by clinical opioid withdrawal scale (COWS) and subjective opioid withdrawal scale (SOWS)

  3. Changes in client-reported opioid craving [ Time Frame: 48 weeks ]
    Change in client-reported opioid craving assessed by opioid craving scale

  4. Changes in client-reported drug use [ Time Frame: 48 weeks ]
    Change in client-reported use of opioids and other drugs, assessed by the Australian Treatment Outcomes Profile (ATOP) instrument

  5. BUP-XR dosing schedule adherence [ Time Frame: 48 weeks ]
    To evaluate client utilisation of buprenorphine medication during the study, including BUP-XR dose variation, adherence with dosing schedule, and dose supplementation

  6. BUP-XR safety and tolerability [ Time Frame: 48 weeks ]
    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

  7. Changes in client-report pain and enjoyment [ Time Frame: 48 weeks ]
    To describe client-reported changes to pain and enjoyment of life, assessed by the Pain, Enjoyment, General Activity (PEG) scale

  8. Demographic factors associated with treatment retention [ Time Frame: 48 weeks ]
    To evaluate demographic factors (gender, age, education) associated with treatment retention, assessed by demographic questionnaire

  9. Client treatment satisfaction score [ Time Frame: 48 weeks ]
    Client-reported treatment satisfaction assessed by the Treatment Questionnaire for Medication Satisfaction (TQSM)

  10. BUP-XR treatment costs [ Time Frame: 48 weeks ]
    Costs to services delivering BUP-XR assessed by site-reported expenses and time and motion study


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

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
Contacts and Locations

Locations
Layout table for location information
Australia, New South Wales
Drug and Alcohol Services, Hunter New England Local Health District
Newcastle, New South Wales, Australia, 2300
Drug and Alcohol Services, North Sydney Local Health District
Saint Leonards, New South Wales, Australia, 2065
Australia, South Australia
Drug and Alcohol Services, South Australia (DASSA)
Morphett Vale, South Australia, Australia, 5162
Australia, Victoria
Western Health Drug Services, Footscray Hospital
Footscray, Victoria, Australia, 3011
Frankston Healthcare
Frankston, Victoria, Australia, 3199
Australia
Rankin Court Treatment Centre, St Vincent's Hospital Sydney
Darlinghurst, Australia, 2010
Sponsors and Collaborators
The University of New South Wales
Investigators
Layout table for investigator information
Principal Investigator: Michael Farrell National Drug and Alcohol Centre, University of New South Wales
Tracking Information
First Submitted Date  ICMJE January 16, 2019
First Posted Date  ICMJE January 18, 2019
Last Update Posted Date March 5, 2020
Actual Study Start Date  ICMJE May 22, 2019
Estimated Primary Completion Date November 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 16, 2019)
Participant retention [ Time Frame: Retention in dosing schedule at 48 weeks ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2020)
  • BUP-XR treatment retention and engagement in ongoing clinical care [ Time Frame: 48 weeks ]
    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 [ Time Frame: 48 weeks ]
    Change in opioid withdrawal assessed by clinical opioid withdrawal scale (COWS) and subjective opioid withdrawal scale (SOWS)
  • Changes in client-reported opioid craving [ Time Frame: 48 weeks ]
    Change in client-reported opioid craving assessed by opioid craving scale
  • Changes in client-reported drug use [ Time Frame: 48 weeks ]
    Change in client-reported use of opioids and other drugs, assessed by the Australian Treatment Outcomes Profile (ATOP) instrument
  • BUP-XR dosing schedule adherence [ Time Frame: 48 weeks ]
    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 [ Time Frame: 48 weeks ]
    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 [ Time Frame: 48 weeks ]
    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 [ Time Frame: 48 weeks ]
    To evaluate demographic factors (gender, age, education) associated with treatment retention, assessed by demographic questionnaire
  • Client treatment satisfaction score [ Time Frame: 48 weeks ]
    Client-reported treatment satisfaction assessed by the Treatment Questionnaire for Medication Satisfaction (TQSM)
  • BUP-XR treatment costs [ Time Frame: 48 weeks ]
    Costs to services delivering BUP-XR assessed by site-reported expenses and time and motion study
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Community Studies of Long Acting Buprenorphine (CoLAB)
Official Title  ICMJE An Open-label, Multicentre, Single-arm Trial of Monthly Injections of Depot Buprenorphine in People With Opioid Dependence
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Opioid Dependence
Intervention  ICMJE Drug: 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.
Other Name: Sublocade
Study Arms  ICMJE Experimental: Depot buprenorphine arm
All participants will receive monthly injections of depot buprenorphine (RBP-6000, Sublocade)
Intervention: Drug: RBP-6000
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 16, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 30, 2021
Estimated Primary Completion Date November 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03809143
Other Study ID Numbers  ICMJE CoLAB1801
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Marianne Byrne, The University of New South Wales
Study Sponsor  ICMJE The University of New South Wales
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Farrell National Drug and Alcohol Centre, University of New South Wales
PRS Account The University of New South Wales
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP