Effects of Modafinil on Sleep Pattern during Methamphetamine Withdrawal: A Double-blind Randomized Controlled Trial

Background: Methamphetamine (MA) abuse is a serious and costly public health problem worldwide; It also commonly affects the sleep quality. The present study was carried out aiming to evaluate the effectiveness of modafinil versus placebo on sleep pattern in MA withdrawal during an eight-week period. Methods: In a double-blind randomized controlled study, a total of ۸۰ patients with a confirmed diagnosis MA withdrawal were treated with modafinil (۲۰۰ mg/day). Pittsburgh Sleep Quality Index (PSQI) and Epworth sleepiness scale (ESS) were used to assess sleep pattern in the ۱th and ۵۶th days of the study. Analysis of covariance (ANCOVA) was applied to compare the groups. All analyses were performed by using SPSS software with a ۵% significance level. Findings: The mean age of the people in the intervention and placebo groups was ۳۲.۹۲ ± ۲.۰۶ and ۳۴.۰۸ ± ۲.۱۳ years, respectively. The mean scores of ESS decreased from ۱۶.۱۵ ± ۴.۵۰ to ۹.۱۵ ± ۳.۳۴ after the intervention in the modafinil group (P < ۰.۰۰۱), with no significant reduction in the placebo group (P = ۰.۹۹۰). The mean scores of PSQI decreased from ۱۳.۸۸ ± ۳.۴۰ to ۹.۹۲ ± ۳.۱۰ after the intervention in the modafinil group (P < ۰.۰۰۱), however there was no significant reduction in the placebo group (P = ۰.۹۸۰). The value of the Eta effect size of the PSQI and ESS questionnaires was ۰.۵۲ and ۰.۷۲, respectively. Modafinil was superior to placebo in improving the PSQI and ESS scales in the ۵۶th day of assessment (P < ۰.۰۵۰). Conclusion: Modafinil improves the sleep quality in patients with MA withdrawal.

Keywords:

Methamphetamine , Modafinil , Placebo , sleep