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

Abstract

BackgroundMethamphetamine (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.MethodsIn a double-blind randomized controlled study, a total of 80 patients with a confirmed diagnosis MA withdrawal were treated with modafinil (200 mg/day). Pittsburgh Sleep Quality Index (PSQI) and Epworth sleepiness scale (ESS) were used to assess sleep pattern in the 1st and 56th days of the study. Analysis of covariance (ANCOVA) was applied to compare the groups. All analyses were performed by using SPSS software with a 5% significance level.FindingsThe mean age of the people in the intervention and placebo groups was 32.92 ± 2.06 and 34.08 ± 2.13 years, respectively. The mean scores of ESS decreased from 16.15 ± 4.50 to 9.15 ± 3.34 after the intervention in the modafinil group (P < 0.001), with no significant reduction in the placebo group (P = 0.990). The mean scores of PSQI decreased from 13.88 ± 3.40 to 9.92 ± 3.10 after the intervention in the modafinil group (P < 0.001), however there was no significant reduction in the placebo group (P = 0.980). The value of the Eta effect size of the PSQI and ESS questionnaires was 0.52 and 0.72, respectively. Modafinil was superior to placebo in improving the PSQI and ESS scales in the 56th day of assessment (P < 0.050).ConclusionModafinil improves the sleep quality in patients with MA withdrawal.