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 Jan 1;120(1-3):135-41.
doi: 10.1016/j.drugalcdep.2011.07.007. Epub 2011 Aug 12.

Modafinil for the treatment of methamphetamine dependence

Ann L Anderson  1 , Shou-Hua Li, Kousick Biswas, Frances McSherry, Tyson Holmes, Erin Iturriaga, Roberta Kahn, Nora Chiang, Thomas Beresford, Jan Campbell, William Haning, Joseph Mawhinney, Michael McCann, Richard Rawson, Christopher Stock, Dennis Weis, Elmer Yu, Ahmed M Elkashef
Affiliations
Randomized Controlled Trial

Modafinil for the treatment of methamphetamine dependence

Ann L Anderson et al. Drug Alcohol Depend. .

Abstract

Aim: Modafinil was tested for efficacy in decreasing use in methamphetamine-dependent participants, compared to placebo.

Methods: This was a randomized, double-blind, placebo-controlled study, with 12 weeks of treatment and a 4-week follow-up. Eight outpatient substance abuse treatment clinics participated in the study. There were 210 treatment-seekers randomized, who all had a DSM-IV diagnosis of methamphetamine dependence; 68 participants to placebo, 72 to modafinil 200mg, and 70 to modafinil 400mg, taken once daily on awakening. Participants came to the clinic three times per week for assessments, urine drug screens, and group psychotherapy. The primary outcome measure was a methamphetamine non-use week, which required all the week's qualitative urine drug screens to be negative for methamphetamine.

Results: Regression analysis showed no significant difference between either modafinil group (200 or 400mg) or placebo in change in weekly percentage having a methamphetamine non-use week over the 12-week treatment period (p=0.53). Similarly, a number of secondary outcomes did not show significant effects of modafinil. However, an ad-hoc analysis of medication compliance, by urinalysis for modafinil and its metabolite, did find a significant difference in maximum duration of abstinence (23 days vs. 10 days, p=0.003), between those having the top quartile of compliance (>85% of urines were positive for modafinil, N=36), and the lower three quartiles of modafinil 200 and 400mg groups (N=106).

Conclusions: Although these data suggest that modafinil, plus group behavioral therapy, was not effective for decreasing methamphetamine use, the study is probably inconclusive because of inadequate compliance with taking medication.

PubMed Disclaimer

Conflict of interest statement

Conflict of Interest: All authors declare that they have no conflicts of interest, i.e., no actual or potential conflict of interest including any financial, personal or other relationships with people or organizations within three (3) years of beginning the work submitted that could inappropriately influence, or be perceived to influence, this work.

Figures

1
1
Flow chart for numbers of participants screened, randomized, and treated in a clinical trial of modafinil for methamphetamine dependence.
2
2
Retention, or percent of participants remaining in the study over 12 weeks, by treatment group.
3
3
Compliance correlation, or percent of expected modafinil taken, self-report (aided by pill count) vs. weekly urine assay.
4
4
Efficacy, or percent of participants having a methamphetamine non-use week (all urines negative) over 12 weeks, by treatment group. GEE fit lines and group means.
5
5
Retention by modafinil compliance groups, top quartile of compliance vs. remaining three quartiles, percent of participants remaining in the study over 12 weeks.
See this image and copyright information in PMC

References

    1. Adler LA, Spencer T, Faraone SV, Reimherr FW, Kelsey D, Michelson D, Biederman J. Training raters to assess adult ADHD: reliability of ratings. J Atten Disord. 2005;8:121–126. - PubMed
    1. Anderson AL, Reid MS, Li SH, Holmes T, Shemanski L, Slee A, Smith EV, Kahn R, Chiang N, Vocci F, Ciraulo D, Dackis C, Roache JD, Salloum IM, Somoza E, Urschel HC, 3rd, Elkashef AM. Modafinil for the treatment of cocaine dependence. Drug Alcohol Depend. 2009;104:133–139. - PMC - PubMed
    1. Ballon JS, Feifel D. A systematic review of modafinil: potential clinical uses and mechanisms of action. J Clin Psychiatry. 2006;67:554–566. - PubMed
    1. Cephalon, Inc. Cephalon, Inc.; Frazer, PA: 2007. [accessed 02/04/11]. PROVIGIL® (modafinil) Tablets [C-IV], FDA Approved Labeling - dated August 17, 2007. www.accessdata.fda.gov/drugsatfda_docs/label/2007/020717s020s013s018lbl.pdf.
    1. Dackis CA, Kampman KM, Lynch KG, Pettinati HM, O'Brien CP. A double-blind, placebo-controlled trial of modafinil for cocaine dependence. Neuropsychopharmacology. 2005;30:205–211. - PubMed

Publication types