A double blind, placebo controlled trial of modafinil for the treatment of cocaine dependence without co-morbid alcohol dependence

• Published in: Drug and alcohol dependence Vol. 155; pp. 105 - 110
• Main Authors: Kampman, Kyle M., Lynch, Kevin G., Pettinati, Helen M., Spratt, Kelly, Wierzbicki, Michael R., Dackis, Charles, O’Brien, Charles P.
• Format: Journal Article
• Language: English
• Published: Ireland Elsevier Ireland Ltd 01.10.2015
• Subjects: Adolescent; Adult; Alcohol; Alcoholism - epidemiology; Benzhydryl Compounds - adverse effects; Benzhydryl Compounds - therapeutic use; Clinical trial; Cocaine; Cocaine - analogs & derivatives; Cocaine - urine; Cocaine-Related Disorders - drug therapy; Cocaine-Related Disorders - epidemiology; Cocaine-Related Disorders - urine; Cognitive Therapy; Combined Modality Therapy; Craving - drug effects; Double-Blind Method; Female; Humans; Male; Medication Adherence - statistics & numerical data; Middle Aged; Modafinil; Patient Compliance - statistics & numerical data; Placebo; Psychiatric Status Rating Scales; Psychiatry; Treatment Outcome; Young Adult; Alcohol; Clinical trial; Cocaine; Modafinil; Placebo
• ISSN: 0376-8716; 1879-0046; 1879-0046
• DOI: 10.1016/j.drugalcdep.2015.08.005

•This was a double blind placebo controlled trial of modafinil for cocaine dependence.•It involved 94 subjects treated with 300mg of modafinil or placebo daily for 8 weeks.•Modafinil treated subjects were more likely to achieve cocaine abstinence.•Modafinil treated subjects were more likely to report very low levels of cocaine craving.•Modafinil treated subjects were more likely to rate themselves very much improved. 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. 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). 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%, χ2=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). Modafinil may be an efficacious treatment for cocaine dependence.