Deakin University
Browse
dean-studyprotocolfor-2019.pdf (969.36 kB)

A study protocol for the N-ICE trial: A randomised double-blind placebo-controlled study of the safety and efficacy of N-acetyl-cysteine (NAC) as a pharmacotherapy for methamphetamine (“ice”) dependence

Download (969.36 kB)
conference contribution
posted on 2019-11-01, 00:00 authored by Rebecca McKetin, Olivia DeanOlivia Dean, Alyna TurnerAlyna Turner, Peter J Kelly, Brendan Quinn, Dan I Lubman, Paul M Dietze, Gregory Carter, Peter Higgs, Amanda L Baker, Barbara Sinclair, David Reid, Victoria Manning, Nina Te Pas, Wenbin Liang, Tamsin Thomas, Ramez Bathish, Margaret Kent, Dayle K Raftery, Shalini Arunogiri, Frank Cordaro, Harry HillHarry Hill, Michael BerkMichael Berk
Background: There are currently no approved pharmacotherapies for managing methamphetamine dependence. N-acetylcysteine (NAC) has been found to reduce the craving for methamphetamine and other drugs, but its effect on methamphetamine use and other clinically related endpoints are uncertain. The N-ICE trial is evaluating the safety and
efficacy of NAC as a take-home pharmacotherapy for methamphetamine dependence.
Methods/design: This is a two-arm parallel double-blind placebo-controlled three-site randomised trial (ratio 1:1) using permuted block randomisation, with variable block sizes. It is stratified by site, sex and whether the methamphetamine is injected or not. Participants (N = 180; 60 per site) need to be dependent on methamphetamine, interested in
reducing their methamphetamine use and not currently receiving treatment for substance use disorders. The trial is being conducted in outpatient settings in Melbourne, Geelong and Wollongong, Australia. Participants will receive either 2400 mg oral NAC or a matched placebo, delivered as a take-home medication for 12 weeks. Two 600 mg
capsules are self-administered in the morning and two more in the evening. Adherence is being monitored using eCAP™ medication bottle lids, which record the date and time of each occasion the bottle is opened. The primary outcome is methamphetamine use during the 12-week trial medication period, measured as (a) days of use, assessed
using the timeline followback, and (b) methamphetamine-positive saliva tests, taken weekly. Secondary measures include weekly assessment of methamphetamine craving, severity of methamphetamine dependence,
methamphetamine withdrawal symptoms and psychiatric symptoms (depression, suicidality, psychotic symptoms and hostility). Adverse events are monitored at each weekly assessment. Tolerability is assessed using the Treatment Satisfaction Questionnaire for Medication.
Discussion: The N-ICE trial is the first clinical trial to assess whether NAC can reduce methamphetamine use. This trial will improve our understanding of the potential utility of NAC in managing methamphetamine dependence and clinically related outcomes. If found to be effective, take-home NAC could be a potentially scalable and affordable pharmacotherapy option for treating methamphetamine dependence.
Trial registration: Australian and New Zealand Clinical Trials Registry, ACTRN12618000366257. Registered on 29 May 2018

History

Event

Drug and Alcohol Review : APSAD Conference (2019 : Hobart, Australia)

Volume

38

Issue

S1

Series

Drug & Alcohol Review

Pagination

S71 - S71

Publisher

Wiley-Blackwell Publishing

Location

Hobart, TAS

Place of publication

Chichester, Eng.

Start date

2019-11-11

End date

2019-11-13

ISSN

0959-5236

eISSN

1465-3362

Language

eng

Notes

Paper 208

Publication classification

E3 Extract of paper

Copyright notice

2019, The Authors

Title of proceedings

APSAD 2019 : Australian Professional Society on Alcohol and Other Drugs Conference

Usage metrics

    Research Publications

    Categories

    No categories selected

    Exports

    RefWorks
    BibTeX
    Ref. manager
    Endnote
    DataCite
    NLM
    DC