Conditions: Cocaine-Related Disorders
Keywords: cocaine
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 210
Healthy volunteers: no

Brief summary:
Despite years of active research, there are still no approved medications for the treatment of cocaine dependence. The purpose of this study is to determine the effectiveness of modafinil in treating cocaine-dependent individuals.

Detailed description:
Modafinil is a glutamate-enhancing agent that blunts cocaine euphoria under controlled conditions. Due to its stimulant-like properties, modafinil is also likely to relieve severe cocaine withdrawal symptoms. In turn, this may lead to better clinical outcomes. The purpose of this study is to determine whether modafinil improves abstinence during early recovery from cocaine dependence.

This 6-month, double-blind, placebo-controlled trial will enroll 210 participants with current DSM-IV diagnoses of cocaine dependence. Treatment will occur for 8 weeks. Participants will be randomly assigned to receive a single morning dose of low-dose modafinil (200 mg/day), high-dose modafinil (400 mg/day), or matching placebo tablets. In addition, each week participants will receive manual-guided cognitive behavioral therapy at the Treatment Research Center. At the end of the 8-week treatment period, modafinil or placebo will be abruptly discontinued. One week following, an end of medication evaluation will occur. In addition to this, two follow-up evaluations will take place 3 and 5 months after initial randomization. Efforts will be made to continue evaluation of subjects who decide to discontinue the modafinil treatment. Urine benzoylecgonine levels will be used to measure cocaine abstinence. Craving, withdrawal, retention, and adverse events will also be evaluated.

Arms:
arm 1: Low Dose Modafinil 200 mg daily arm 2: High dose modafinil 400 mg daily arm 3: Placebo

Interventions: intervention 1: Low Dose Modafinil intervention 2: High Dose Modafinil intervention 3: Placebo
Intervention descriptions: intervention 1: modafinil 200 mg/day intervention 2: modafinil 400 mg/day intervention 3: placebo 400 mg/day

Protocol document: