Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2012 Jul;107(7):1297-306.
doi: 10.1111/j.1360-0443.2011.03771.x. Epub 2012 Feb 28.

Topiramate for the treatment of methamphetamine addiction: a multi-center placebo-controlled trial

Ahmed Elkashef  1 , Roberta Kahn, Elmer Yu, Erin Iturriaga, Shou-Hua Li, Ann Anderson, Nora Chiang, Nassima Ait-Daoud, David Weiss, Frances McSherry, Tracey Serpi, Richard Rawson, Mark Hrymoc, Dennis Weis, Michael McCann, Tony Pham, Christopher Stock, Ruth Dickinson, Jan Campbell, Charles Gorodetzky, William Haning, Barry Carlton, Joseph Mawhinney, Ming D Li, Bankole A Johnson
Affiliations
Randomized Controlled Trial

Topiramate for the treatment of methamphetamine addiction: a multi-center placebo-controlled trial

Ahmed Elkashef et al. Addiction. 2012 Jul.

Erratum in

  • Addiction. 2012 Sep;107(9):1718. Dosage error in published abstract; MEDLINE/PubMed abstract corrected

Abstract

Aims: Topiramate has shown efficacy at facilitating abstinence from alcohol and cocaine abuse. This double-blind, placebo-controlled out-patient trial tested topiramate for treating methamphetamine addiction.

Design: Participants (n = 140) were randomized to receive topiramate or placebo (13 weeks) in escalating doses from 25 mg/day [DOSAGE ERROR CORRECTED] to the target maintenance of 200 mg/day in weeks 6-12 (tapered in week 13). Medication was combined with weekly brief behavioral compliance enhancement treatment.

Setting: The trial was conducted at eight medical centers in the United States.

Participants: One hundred and forty methamphetamine-dependent adults took part in the trial.

Measurements: The primary outcome was abstinence from methamphetamine during weeks 6-12. Secondary outcomes included use reduction versus baseline, as well as psychosocial variables.

Findings: In the intent-to-treat analysis, topiramate did not increase abstinence from methamphetamine during weeks 6-12. For secondary outcomes, topiramate reduced weekly median urine methamphetamine levels and observer-rated severity of dependence scores significantly. Subjects with negative urine before randomization (n = 26) had significantly greater abstinence on topiramate versus placebo during study weeks 6-12. Topiramate was safe and well tolerated.

Conclusions: Topiramate does not appear to promote abstinence in methamphetamine users but can reduce the amount taken and reduce relapse rates in those who are already abstinent.

Trial registration: ClinicalTrials.gov NCT00345371.

PubMed Disclaimer

Conflict of interest statement

Declaration of interest: E. Yu serves as a member of the scientific advisory board for US WorldMeds, LLC. C. Gorodetzky serves as a consultant to Catalyst Pharmaceutical Partners, Inc., Helicon Therapeutics, Inc., and US WorldMeds, LLC. M. D. Li serves as a scientific advisor to ADial Pharmaceuticals LLC. B. A. Johnson has served as a consultant to Johnson & Johnson (Ortho-McNeil Janssen Scientific Affairs, LLC), Transcept Pharmaceuticals, Inc., D&A Pharma, Organon, ADial Pharmaceuticals LLC, Psychological Education Publishing Company (PEPCo LLC), and Eli Lilly and Company. A. Elkashef, R. Kahn, E. Iturriaga, S.-H. Li, A. Anderson, N. Chiang, N. Ait-Daoud, D. Weiss, F. McSherry, T. Serpi, R. Rawson, M. Hrymoc, D. Weis, M. McCann, T. Pham, C. Stock, R. Dickinson, J. Campbell, W. Haning, B. Carlton, and J. Mawhinney report no competing interests.

Figures

Figure 1
Figure 1
Trial flow diagram.
Figure 2
Figure 2
Study retention for the topiramate and placebo groups.
Figure 3
Figure 3
Percentage of subjects with a negative methamphetamine use week during weeks 6–12 for topiramate (N=69) and placebo (N=71). Generalized estimating equations (GEE) result for treatment over weeks 6–12 (p=0.13).
Figure 4
Figure 4
Treatment group and last urine result prior to randomization for the percentage of subjects with a negative methamphetamine use week in study weeks 6–12. At week 6, the total sample size of subjects with a negative baseline urine test for methamphetamine use was 26, with 13 in the placebo group and 13 in the topiramate group. At week 6, the total sample size of subjects with a positive baseline urine test for methamphetamine use was 78, with 38 in the placebo group and 40 in the topiramate group.
See this image and copyright information in PMC

Comment in

References

    1. Johnson BA, Ait-Daoud N, Bowden CL, DiClemente CC, Roache JD, Lawson K, et al. Oral topiramate for treatment of alcohol dependence: a randomised controlled trial. Lancet. 2003;361:1677–1685. - PubMed
    1. Johnson BA, Rosenthal N, Capece JA, Wiegand F, Mao L, Beyers K, et al. Topiramate for treating alcohol dependence: a randomized controlled trial. JAMA. 2007;298:1641–1651. - PubMed
    1. Kampman KM, Pettinati H, Lynch KG, Dackis C, Sparkman T, Weigley C, et al. A pilot trial of topiramate for the treatment of cocaine dependence. Drug Alcohol Depend. 2004;75:233–240. - PubMed
    1. Kushner SA, Dewey SL, Kornetsky C. The irreversible gamma-aminobutyric acid (GABA) transaminase inhibitor gamma-vinyl-GABA blocks cocaine self-administration in rats. J Pharmacol Exp Ther. 1999;290:797–802. - PubMed
    1. Gryder DS, Rogawski MA. Selective antagonism of GluR5 kainate-receptor-mediated synaptic currents by topiramate in rat basolateral amygdala neurons. J Neurosci. 2003;23:7069–7074. - PMC - PubMed

Publication types

Associated data