Serious adverse events in the Australian National Evaluation of Pharmacotherapies for Opioid Dependence (NEPOD)

E. Digiusto; A. Shakeshaft; A. Ritter; S. O'Brien; R. P. Mattick; The NEPOD Research Group

doi:10.1111/j.1360-0443.2004.00654.x

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Serious adverse events in the Australian National Evaluation of Pharmacotherapies for Opioid Dependence (NEPOD)

Journal article

Peer reviewed

Serious adverse events in the Australian National Evaluation of Pharmacotherapies for Opioid Dependence (NEPOD)

E. Digiusto, A. Shakeshaft, A. Ritter, S. O'Brien, R. P. Mattick and The NEPOD Research Group

Addiction , Vol.99(4), pp.450-460

2004

DOI: https://doi.org/10.1111/j.1360-0443.2004.00654.x

PMID: 15049745

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Abstract

Adverse events

buprenorphine

heroin overdose

LAAM

methadone

naltrexone

NEPOD

opioid dependence

Aims: The study estimated serious adverse event (SAE) rates among entrants to pharmacotherapies for opioid dependence, during treatment and after leaving treatment. Design: A longitudinal study based on data from 12 trials included in the Australian National Evaluation of Pharmacotherapies for Opioid Dependence (NEPOD). Participants and settings: A total of 1244 heroin users and methadone patients treated in hospital, community and GP settings. Intervention Six trials included detoxification; all included treatment with methadone, buprenorphine, levo-alpha-acetyl-methadol (LAAM) or naltrexone. Findings: During 394 person-years of observation, 79 SAEs of 28 types were recorded. Naltrexone participants experienced 39 overdoses per 100 person-years after leaving treatment (44% occurred within 2 weeks after stopping naltrexone). This was eight times the rate recorded among participants who left agonist treatment. Rates of all other SAEs were similar during treatment versus out of treatment, for both naltrexone-treated and agonist-treated participants. Five deaths occurred, all among participants who had left treatment, at a rate of six per 100 person-years. Total SAE rates during naltrexone and agonist treatments were similar (20, 14 per 100 person-years, respectively). Total SAE and death rates observed among participants who had left treatment were three and 19 times the corresponding rates during treatment. Conclusions: Individuals who leave pharmacotherapies for opioid dependence experience higher overdose and death rates compared with those in treatment. This may be due partly to a participant self-selection effect rather than entirely to pharmacotherapy being protective. Clinicians should alert naltrexone treatment patients in particular about heroin overdose risks. Duty of care may extend beyond cessation of dosing.

Details

Title: Serious adverse events in the Australian National Evaluation of Pharmacotherapies for Opioid Dependence (NEPOD)
Authors: E. Digiusto (Corresponding Author) - UNSW Sydney
A. Shakeshaft - UNSW Sydney
A. Ritter - Turning Point Alcohol and Drug Centre
S. O'Brien - UNSW Sydney
R. P. Mattick - UNSW Sydney
The NEPOD Research Group (Author)
Publication details: Addiction , Vol.99(4), pp.450-460
Publisher: Wiley-Blackwell Publishing Ltd.
Date published: 2004
DOI: 10.1111/j.1360-0443.2004.00654.x
ISSN: 1360-0443
PMID: 15049745
Grant note: Funding for the NEPOD Project was provided by the Commonwealth Department of Health and Aged care. The trials included herein were funded by The Victorian government’s Turning the Tide Community Support Fund, the Health Departments of New South Wales, South Australia and Queensland,
Organisation Unit: School of Health - Psychology
Language: English
Record Identifier: 991241463302621
Output Type: Journal article

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