title: A double blind, placebo controlled trial of modafinil for the treatment of cocaine dependence without co-morbid alcohol dependence.
abstract: BACKGROUND
  Modafinil is a medication approved for narcolepsy and shift work sleep disorder. It has both dopaminergic and glutamatergic activity that could be useful for the treatment of cocaine dependence. Modafinil has reduced cocaine subjective effects and cocaine self-administration in human laboratory trials and has reduced cocaine use in cocaine dependent patients in some clinical trials.
  
  
  METHODS
  This was an 8-week, double blind, placebo controlled clinical trial involving 94 cocaine dependent subjects. Subjects received 300mg of modafinil or identical placebo daily along with weekly individual therapy. The primary outcome measure was cocaine use measured by self-report, and confirmed by twice weekly urine benzoylecgonine tests (UBT). Additional outcome measures included cocaine craving measured by the Brief Substance Craving Scale and global improvement measured by the Clinical Global Impression Scale (CGI).
  
  
  RESULTS
  The odds ratio (OR) in favor of abstinence for modafinil vs. placebo was 2.54 (p=. 03) and modafinil-treated subjects were significantly more likely than placebo-treated subjects to be abstinent from cocaine during the last 3 weeks of the trial, 23% vs. 9%, χ(2)=3.9, p<.05. Modafinil treated subjects were more likely to report very low levels of cocaine craving intensity and duration on the Brief Substance Craving Scale (OR=2.04, p=.03 and OR 1.06, p=.03 respectively). Modafinil-treated subjects were also more likely than placebo-treated subjects to rate themselves as "very much improved" on the CGI (OR=2.69, p=.03).
  
  
  CONCLUSIONS
  Modafinil may be an efficacious treatment for cocaine dependence.
authors: Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, 3900 Chestnut Street, Philadelphia, PA 19104, USA. Electronic address: kampman@upenn.edu.
authors: Kyle M
authors: KM
authors: Kampman
authors: Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, 3900 Chestnut Street, Philadelphia, PA 19104, USA.
authors: Kevin G
authors: KG
authors: Lynch
authors: Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, 3900 Chestnut Street, Philadelphia, PA 19104, USA.
authors: Helen M
authors: HM
authors: Pettinati
authors: Department of Medicine, Perelman School of Medicine, University of Pennsylvania, 3400 Spruce Street, Philadelphia, PA 19104, USA.
authors: Kelly
authors: K
authors: Spratt
authors: Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, 3400 Spruce Street, Philadelphia, PA 19104, USA.
authors: Michael R
authors: MR
authors: Wierzbicki
authors: Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, 3900 Chestnut Street, Philadelphia, PA 19104, USA.
authors: Charles
authors: C
authors: Dackis
authors: Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, 3900 Chestnut Street, Philadelphia, PA 19104, USA.
authors: Charles P
authors: CP
authors: O'Brien
mesh_terms: D000293:Adolescent; D000328:Adult; D000437:Alcoholism / Q000453:epidemiology; D001559:Benzhydryl Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D003042:Cocaine / Q000031:analogs & derivatives / Q000652:urine; D019970:Cocaine-Related Disorders / Q000188:drug therapy* / Q000453:epidemiology / Q000652:urine; D015928:Cognitive Behavioral Therapy; D003131:Combined Modality Therapy; D066249:Craving / Q000187:drug effects; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077408:Modafinil; D010349:Patient Compliance / Q000706:statistics & numerical data; D011569:Psychiatric Status Rating Scales; D016896:Treatment Outcome; D055815:Young Adult; D016903:Drug Monitoring
chemical_list: D001559:Benzhydryl Compounds; C005618:benzoylecgonine; D003042:Cocaine; D000077408:Modafinil
keywords: Alcohol; Clinical trial; Cocaine; Modafinil; Placebo