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IRCT20181218042036N1 IRCT 2019-03-16 Mazandaran University of Medical Sciences Modafinil effect on sleep of patient with methamphetamine dependency Comparison of the effectiveness of Modafinil with placebo on sleep of patients diagnosed with methamphetamine dependency 2018-09-06 anticipated 80 Complete https://irct.ir/trial/36123 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients have randomized in 20 blocks (4 patients per block) into intervention and control group using a random number table, Blinding description: Randomization was performed by an independent person, who was not involved elsewhere in the trial. Participants did not know the type of medicine used (monafinil / placebo). Clinical care did not know the type of medicine used (monafinil / placebo).Investigator of the outcome did not know the type of medicine used (monafinil / placebo).The data analyst did not know the type of medicine used (monafinil / placebo).Concealment of allocation was performed using sequentially numbered, sealed, opaque and stapled envelopes. Separate people were responsible for generation of randomization codes, treatment allocation and interviewing. The patients, research investigators and interviewers were all blinded to the treatment allocation. Modafinil and placebo were completely identical in their size, color, shape, texture and odor. 4 sleep. Intervention 1: Intervention group: The participants started 100 mg of modafinil by a day. Psychiatric interview was done for all patients according to DSM-5 and SCID. Prescriptive modafinil used from Sobhan pharmaceutic company in Iran. Intervention 2: Control group: The participants started 100 mg of placebo by a day and after three days, they received 200 mg of placebo by a day until the end of week 8. Psychiatric interview was done for all patients according to DSM-5 and SCID. Prescriptive placebo used from Sobhan pharmaceutic company in Iran. No - There is not a plan to make this available Justification or reason for not sharing IPD is Dissatisfaction of the participants in the study
public fatemeh Amini
Pasdaran Bulevard
Sari Iran (Islamic Republic of) 4815838531 +98 33343104 f.amini@mazums.ac.ir Mazandaran University of Medical Sciences scientific Fatemeh Amini
Sarv Ave., Rafi St., Pasdaran Blvd., Sari Town
Sari Iran (Islamic Republic of) 4815838531 +98 11 3334 3104 f.amini@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) eighteen to sixty five years of age recently methamphetamine dependency based on the diagnostic and statistical manual of mental disorders, 5th edition, text revision (DSM-5) and SCID criteria methamphetamine dependency based on the diagnostic and statistical manual of mental disorders, 5th edition, text revision (DSM-5) and SCID criteria The desire to attend this study Continuation of the study until the end 18 years 65 years Male The presence of a significant physical illness such as serious coronary, liver disease, uncontrolled diabetes, uncontrolled hypertension and increased liver enzymes more than three time normal significant neurologic or psychiatric primary illness based on SCID by a psychiatrist, having suicidal thoughts and aggression Treatment - Drugs Placebo Intervention group: The participants started 100 mg of modafinil by a day. Psychiatric interview was done for all patients according to DSM-5 and SCID. Prescriptive modafinil used from Sobhan pharmaceutic company in Iran. Control group: The participants started 100 mg of placebo by a day and after three days, they received 200 mg of placebo by a day until the end of week 8. Psychiatric interview was done for all patients according to DSM-5 and SCID. Prescriptive placebo used from Sobhan pharmaceutic company in Iran. Sleep pattern. Timepoint: in 1th and 56th day of the study. Method of measurement: Pittsburgh sleep quality index (PSQI) and Epworth sleepiness scale (ESS) were used to assess sleep pattern. Mazandaran University of Medical Sciences Approved 2018-06-18 Ethics Committee of Mazandaran University of Medical Sciencesthe Moalem Street Sari Mazandaran Iran (Islamic Republic of)