In this trial, modafinil at a dose of 300 mg daily was superior to placebo at promoting cocaine abstinence in cocaine dependent subjects measured by self-report and verified by UBT. Modafinil treated subjects were more likely to rate themselves as very much improved. Modafinil treated subjects were also more likely to report the lowest levels of cocaine craving intensity and duration measured by the BSCS.
This is the second trial of modafinil in which modafinil was superior to placebo in the predefined primary outcome in the complete sample. In the first controlled trial of modafinil, Dackis et al. (2005) found that modafinil-treated subjects submitted more negative UBT compared to placebo treated subjects. In other trials, post hoc analyses support the efficacy of modafinil for subgroups of cocaine dependent patients. For instance, in a multicenter trial of modafinil for cocaine dependence Anderson and colleagues showed that cocaine dependent subjects without comorbid alcohol dependence had significantly more cocaine non-use days if they were treated with modafinil compared to placebo (Anderson et al., 2009). In another trial, Dackis et al. (2012) found that men treated with modafinil submitted significantly fewer cocaine positive UBT.