Randomized, double-blind, placebo-controlled trial of modafinil for the treatment of methamphetamine dependence.
OBJECTIVE
To compare modafinil to placebo for reducing methamphetamine (MA) use, improving retention, and reducing depressive symptoms and MA cravings. Rates of adverse events and cigarette smoking with modafinil versus placebo were also compared.


METHODS
Following a 2-week, non-medication lead-in period, 71 treatment-seeking MA-dependent participants were randomly assigned to modafinil (400mg once daily; N=34) or placebo (once daily; N=37) for 12 weeks under double-blind conditions. Participants attended clinic thrice-weekly to provide urine samples analyzed for MA-metabolite, to complete research assessments, and to receive contingency management and weekly cognitive behavioral therapy (CBT) sessions.


RESULTS
There were no statistically significant effects for modafinil on MA use, retention, depressive symptoms, or MA cravings in pre-planned analyses. Outcomes for retention and MA use favored modafinil in a post hoc analysis among participants with low CBT attendance and among participants with baseline high-frequency of MA use (MA use on >18 of past 30 days), but did not reach statistical significance in these small subgroups. Modafinil was safe and well tolerated and did not increase cigarette smoking.


CONCLUSIONS
Modafinil was no more effective than placebo at 400mg daily in a general sample of MA users. A post hoc analysis showing a trend favoring modafinil among subgroups with baseline high-frequency MA use and low CBT attendance suggests that further evaluation of modafinil in MA users is warranted.
Heinzerling
Keith G
KG
Department of Family Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA 90095, USA. KHeinzerling@mednet.ucla.edu
Swanson
Aimee-Noelle
AN
Kim
Soeun
S
Cederblom
Lisa
L
Moe
Ardis
A
Ling
Walter
W
Shoptaw
Steven
S
D000293:Adolescent; D000328:Adult; D019969:Amphetamine-Related Disorders / Q000188:drug therapy* / Q000523:psychology; D001559:Benzhydryl Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D000697:Central Nervous System Stimulants / Q000009:adverse effects / Q000627:therapeutic use*; D015928:Cognitive Behavioral Therapy; D003376:Counseling; D003627:Data Interpretation, Statistical; D003866:Depressive Disorder / Q000517:prevention & control / Q000523:psychology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008694:Methamphetamine; D000077408:Modafinil; D010349:Patient Compliance; D011569:Psychiatric Status Rating Scales; D012907:Smoking / Q000453:epidemiology; D012959:Socioeconomic Factors; D015813:Substance Abuse Detection; D016896:Treatment Outcome; D055815:Young Adult
D001559:Benzhydryl Compounds; D000697:Central Nervous System Stimulants; D008694:Methamphetamine; D000077408:Modafinil