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Open Access Highly Accessed Study protocol

Cohort protocol paper: The Pain and Opioids In Treatment (POINT) study

Gabrielle Campbell1*, Richard Mattick1, Raimondo Bruno12, Briony Larance1, Suzanne Nielsen134, Milton Cohen5, Nicholas Lintzeris34, Fiona Shand6, Wayne D Hall78, Bianca Hoban1, Chyanne Kehler1, Michael Farrell1 and Louisa Degenhardt110119

Author Affiliations

1 National Drug and Alcohol Research Centre, UNSW, Sydney, NSW 2052, Australia

2 School of Medicine, University of Tasmania, Hobart, Tasmania, Australia

3 Discipline of Addiction Medicine, The University of Sydney, Sydney, Australia

4 The Langton Centre, South East Sydney Local Health District (SESLHD) Drug and Alcohol Services, Surry Hills, Australia

5 St Vincent’s Clinical School, UNSW Medicine, UNSW, Darlinghurst, Australia

6 Black Dog Institute, UNSW, Randwick, Australia

7 Centre for Youth Substance Abuse Research, University of Queensland, Queensland, Australia

8 National Addiction Centre, Kings College, London, England

9 School of Population and Global Health, University of Melbourne, Melbourne, Australia

10 Centre for Adolescent Health, Murdoch Children’s Research Institute, Melbourne, Australia

11 Department of Global Health, School of Public Health, University of Washington, Seattle, USA

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BMC Pharmacology and Toxicology 2014, 15:17  doi:10.1186/2050-6511-15-17

Published: 20 March 2014

Abstract

Background

Internationally, there is concern about the increased prescribing of pharmaceutical opioids for chronic non-cancer pain (CNCP). In part, this is related to limited knowledge about the long-term benefits and outcomes of opioid use for CNCP. There has also been increased injection of some pharmaceutical opioids by people who inject drugs, and for some patients, the development of problematic and/or dependent use. To date, much of the research on the use of pharmaceutical opioids among people with CNCP, have been clinical trials that have excluded patients with complex needs, and have been of limited duration (i.e. fewer than 12 weeks). The Pain and Opioids In Treatment (POINT) study is unique study that aims to: 1) examine patterns of opioid use in a cohort of patients prescribed opioids for CNCP; 2) examine demographic and clinical predictors of adverse events, including opioid abuse or dependence, medication diversion, other drug use, and overdose; and 3) identify factors predicting poor pain relief and other outcomes.

Methods/Design

The POINT cohort comprises around 1,500 people across Australia prescribed pharmaceutical opioids for CNCP. Participants will be followed-up at four time points over a two year period. POINT will collect information on demographics, physical and medication use history, pain, mental health, drug and alcohol use, non-adherence, medication diversion, sleep, and quality of life. Data linkage will provide information on medications and services from Medicare (Australia’s national health care scheme). Data on those who receive opioid substitution therapy, and on mortality, will be linked.

Discussion

This study will rigorously examine prescription opioid use among CNCP patients, and examine its relationship to important health outcomes. The extent to which opioids for chronic pain is associated with pain reduction, quality of life, mental and physical health, aberrant medication behavior and substance use disorders will be extensively examined. Improved understanding of the longer-term outcomes of chronic opioid therapy will direct community-based interventions and health policy in Australia and internationally. The results of this study will assist clinicians to better identify those patients who are at risk of adverse outcomes and who therefore require alternative treatment strategies.

Keywords:
Opioids; Chronic non-cancer pain; Pain; Quality of life; Dependence; Non-adherence