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An open-label, multicentre, single-arm trial of monthly injections of depot buprenorphine in people with opioid dependence

image - CoLAB
Date Commenced:
08/2018
Expected Date of Completion:
08/2020
Project Supporters:

Funding support provided by Indivior PLC, through an Externally Sponsored Collaborative Research grant

Drug Type:
Project Members: 
image - Michael Farrell 0
Director
Ph EA Tori Barnes: 02 9385 0292 / t.barnes@unsw.edu.au
image - Briony Larance Square
Conjoint Senior Lecturer
Ph 02 9385 0333
image - Marian Shanahan
Dr Marian Shanahan
Conjoint Senior Lecturer
image - Jeyran Shahbazi
Clinical Project Coordinator
Ph 8936 1040
image - Marianne Byrne
Clinical Trials Manager
Ph +61 (2) 9385 9984
Project Main Description: 

Retaining patients in buprenorphine treatment is essential in maximising treatment outcomes and minimising mortality risk. Delivery of treatment via novel depot buprenorphine products has the potential to enhance patient adherence and retention in treatment. In settings such as Australia, where there is a focus on supervised daily dosing, the reduced frequency of dosing required for a monthly buprenorphine injection may free up service-level resources currently allocated patient monitoring and potentially increase treatment capacity.  However, more real work data are needed.

 

CoLAB is an open-label cohort study of depot buprenorphine evaluating patient outcomes and process and cost implications of implementation in a variety of models of care.   

Project Collaborators: External: 

A/Prof Nicholas Lintzeris
University of Sydney / SESLHD

Prof Robert Ali
University of Adelaide

A/prof Suzanne Nielson
Monash University

Prof Jason Grebely
Kirby Institute, UNSW

Prof Carla Treloar
Centre for Social Research in Health, UNSW

A/Prof Adrian Dunlop
HNELHD

Dr Craig Rodgers
SVHS

Rationale: 

Current standard sublingual BPN treatment is closely monitored, with typically daily or close-to-daily visits for supervised dosing at specialist clinics or community pharmacies. With the introduction of monthly BPN injections, this level of monitoring and attendance may no longer be required. It is important to understand how this impacts on patient outcomes; whether similar patient outcomes can be achieved with less frequent contact with treatment services.  

In addition, making the shift to injectable treatments has important service- and system-level implications, including the development of new models of care and new procedures for drug storage and administration (particularly Schedule 8 cold storage requirements in the context of RBP-6000). 

The desirable length of BPN treatment is typically long-term (12 months or more), and to date there is limited data regarding safety (adverse events) associated with extended-release BPN injection in the long-term – specifically the potential for local injection site complications (e.g., pain, inflammation). Available studies have documented relatively short duration of treatment of up to 6 months [4, 5], and a more extended period of treatment and adverse event monitoring is needed. 

The diversity of treatment settings in Australia also presents challenges. Although specialist public clinics with onsite pharmacies are available in jurisdictions such as New South Wales and South Australia, the treatment models in other jurisdictions rely predominantly on busy primary care prescribers and community pharmacies (Victoria). Implementation work needs to be conducted to examine different models of delivery, including combinations of specialist vs. primary care prescribers, clinic vs. community pharmacy dosing, and nurse vs. doctor administration of the injections.

Aims: 

This open-label trial is one component of an overall program of work that aims:

1.    To evaluate the patient outcomes following the implementation of a monthly injection of extended-release BPN for the treatment of opioid dependence in community-based treatment settings with a focus on opioid and other illicit drug use, adherence with the administration schedule and participants’ experiences of the implementation; and

2.    To develop and document the implementation of a monthly injection of extended-release BPN for the treatment of opioid dependence in community-based treatment setting with an emphasis on the feasibility and practical clinical, regulatory and supply issues in settings representative of Australian clinical practice.

Design and Method: 

The key components of the CoLAB study are:

  • A cross-sectional survey of N=400 people who are opioid dependent;
  • A single-arm, multi-site, open-label study of monthly injections of extended-release buprenorphine; and
  • A mixed-methods implementation review

The clinical trial component will be conducted as a single-arm, open-label, multi-site trial of depot buprenorphine. A total of 100 people with opioid dependence will be enrolled from Australian study sites, including a mix of service providers in community settings (e.g. primary care based general practitioners and community pharmacies) and in specialist clinic settings. Potential participants will be existing clients of the participating site, already in treatment with sublingual buprenorphine for opioid dependence. 

The study will consist of a screening phase (up to 4 weeks); treatment phase (48 weeks; and follow up for 4 weeks after the last dose of study medication. See the Schedule of Assessments for the data collected at each research visit. All participants will complete research assessments across the 52 week period, including treatment non-completers. 

Other aspects of clinical care will be consistent with standard care for opioid agonist treatment of opioid dependence, including regular clinical reviews and case management, and the availability of psychosocial services.

The implementation component includes:

  • Qualitative research interviews with patients and providers
  • Costing the implementation
  • Development of clinical guidance for the study
Progress/Update: 

Patient recruitment will commence in several Australian states in quarter 1, 2019. 

Benefits: 

It is anticipated that the findings of this project will help to inform revision of National Clinical Guidelines for medication assisted treatment of opioid dependence, and recommendations for models of care for delivery of depot buprenorphine treatment. 

Drug Type: 
Project Status: 
Current