Extended-release methylphenidate for treatment of amphetamine/methamphetamine dependence: a randomized, double-blind, placebo-controlled trial
Article first published online: 1 MAR 2013
© 2013 The Authors, Addiction © 2013 Society for the Study of Addiction
Volume 108, Issue 7, pages 1279–1286, July 2013
How to Cite
Miles, S. W., Sheridan, J., Russell, B., Kydd, R., Wheeler, A., Walters, C., Gamble, G., Hardley, P., Jensen, M., Kuoppasalmi, K., Tuomola, P., Föhr, J., Kuikanmäki, O., Vorma, H., Salokangas, R., Mikkonen, A., Kallio, M., Kauhanen, J., Kiviniemi, V. and Tiihonen, J. (2013), Extended-release methylphenidate for treatment of amphetamine/methamphetamine dependence: a randomized, double-blind, placebo-controlled trial. Addiction, 108: 1279–1286. doi: 10.1111/add.12109
- Issue published online: 7 JUN 2013
- Article first published online: 1 MAR 2013
- Accepted manuscript online: 8 JAN 2013 12:00AM EST
- Manuscript Accepted: 26 DEC 2012
- Manuscript Revised: 19 JUL 2012
- Manuscript Received: 12 JUN 2012
- Niuvanniemi Hospital, Finland
- Oakley Mental Health Foundation (New Zealand)
- Waitemata District Health Board, Auckland (New Zealand)
- clinical trial;
To assess the efficacy of methylphenidate as a substitution therapy for amphetamine/methamphetamine dependence in Finland and New Zealand.
Parallel-group, double-blind, randomized placebo-controlled trial.
Amphetamine-/methamphetamine-dependent, aged 16–65 years.
The primary outcome measure was presence/absence of amphetamine/methamphetamine in urine samples collected twice weekly. Secondary measures included treatment adherence, alterations in craving scores and self-reported use. Primary analysis was by intention-to-treat (ITT). The study drug, methylphenidate (as Concerta®), was up-titrated over 2 weeks to a maximum dose of 54 mg daily and continued for a further 20 weeks. Doses were given under daily supervision at the clinics.
Seventy-nine participants were randomized (40 methylphenidate; 39 placebo); 76 received allocated treatment and 27 completed the trial. ITT analysis (n = 78) showed no statistically significant difference in the percentage of positive urines between the methylphenidate and placebo arms (odds ratio: 0.95, 95% confidence interval: 0.83–1.08). However, there was a significant difference (P < 0.05) between the active and placebo arms in retention, the placebo arm displaying a significantly lower retention from 6 weeks that persisted until the end of the trial.
The trial failed to replicate earlier findings suggesting that methylphenidate was superior to placebo. The low retention rate confounded the ability to draw firm conclusions about efficacy. The higher retention rate was observed in the methylphenidate arm. Any replication of this work would need to consider alternatives to the rigid clinic attendance criteria, and consider an increased dose.