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
Rebecca McKetin, Olivia M Dean, Alyna Turner, Peter J Kelly, Brendan Quinn, Dan I Lubman, Paul 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 Raftery, Shalini Arunogiri Show all
Trials | BMC | Published : 2019
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; 6..View full abstract
Awarded by Australian NHMRC
Awarded by NHMRC senior principal research fellowship
Awarded by NHMRC research fellowship
This research was funded by the Australian NHMRC (project grant 1128147). RM is supported by a Curtin senior research fellowship. OMD is a RD Wright NHMRC biomedical research fellow. MB is supported by an NHMRC senior principal research fellowship (1059660 and 1156072). PD is supported by an NHMRC research fellowship (1136908). We thank the members of our DSMB (Jason White, Matthew Spittal, Deborah Kerr, Grant Sara and Juanita Koeijers). We thank Long Nguyen for developing our online unblinding portal, Steven Shoptaw for advice on trial methods, the other trial staff (including Nicole Edwards, Lucy Saunders, Bruno Agustini, Ellie Brown and Vicky Phan), agencies and individuals who assisted with recruitment efforts, and the trial participants.