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IRCT20191003044971N1 IRCT 2019-11-30 Tehran University of Medical Sciences Evaluation of nasal oxytocin spray efficacy in cutting methadone in opioids addicted people that have received methadone . Evaluation of nasal oxytocin spray efficacy in scales of the withdrawal sign and craving and relapse When cutting methadone in opioids addicted people that have received methadone . 2019-10-07 anticipated 60 Complete https://irct.ir/trial/42724 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Other design features: In this study, 60 patients were randomly assigned into 4 groups of 15 each and the efficacy of group oxytocin Prescription was evaluated.In addition, the efficacy of Prescription of oxytocin or placebo is compared with fmri, Randomization description: Random allocation software, which is part of the random sequence generation software, We randomly divided the subjects into 4 groups by block randomization method, Blinding description: The monitoring expert will label oxytocin nasal spray or sodium chloride solution in similar containers. He then delivers them to a therapist who will be with the patients. The therapist and the patient will be unaware of the actual contents of the containers. 3 drug addiction. Intervention 1: Intervention group: Take oxytocin nasal sprays two puffs every 6 hours in groups with targeted group activities. Intervention 2: Intervention group: Taking placebo nasal spray 2 puffs every 6 hours in groups with targeted group activities. Intervention 3: Intervention group: Take oxytocin nasal spray 2 puffs every 6 hours individually. Intervention 4: Control group: Take placebo nasal spray 2 puffs every 6 hours individually. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public shahram naderi mazjin
no.7, blind alley 2, navid alley, nejatollahi st.,
tehran Iran (Islamic Republic of) 1598996711 +98 21 8894 1372 shahramnadery@yahoo.com Tehran University of Medical Sciences scientific shahram naderi mazjin
no.7, blind alley2, Navid alley,Nejatollahi st.
tehran Iran (Islamic Republic of) 1598996711 +98 21 8894 1372 shahramnadery@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) These people are all men. They are between 18 and 55 years old. They have a history of drug addiction, with the drug being discontinued and replaced with methadone. The amount of methadone consumed is between 10 and 100 mg They have been on methadone maintenance therapy for longer than 6 months now on his own offer Or, as the need arises (example with travel abroad, employment or marriage)he wants to cut off methadone consumption. But despite the high tendency to Interruption of methadone has not been able to reduce methadone levels in 14 days Recently, his methadone dose has not changed. This pations were no positive morphine test for the past 3 months. 18 years 55 years Male There is a history of seizures Recent history of brain injury drug abuse in the past 3 months Severe suicidal thoughts with severe depression Severe allergic disease Severe neurological disorders, especially if it causes increased risk of seizure Acute cardiac abnormalities present History of psychotic disorders acute vascular disorders F11 Mental and behavioural disorders due to use of opioids Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Take oxytocin nasal sprays two puffs every 6 hours in groups with targeted group activities Intervention group: Taking placebo nasal spray 2 puffs every 6 hours in groups with targeted group activities Intervention group: Take oxytocin nasal spray 2 puffs every 6 hours individually Control group: Take placebo nasal spray 2 puffs every 6 hours individually Craving of opioids abuse. Timepoint: Days 2, 3 and 4 after discontinuing methadone. Method of measurement: Self-report based on the ten-point Likert scale. Withdrawal sign of cutting of methadone. Timepoint: Days 2, 3 and 4 after discontinuing methadone. Method of measurement: Self-report based on the ten-point Likert scale. Morphine and methadone test result. Timepoint: At the end of each week after discontinuing methadone until the end of the month 4. Method of measurement: Take a morphine and methadone test. Participate in group therapy. Timepoint: End of each week until the end of the fourth month after discontinuing methadone. Method of measurement: Registration of people attending grouptherapy each week by therapist. Beck Depression and Anxiety Inventory Scale. Timepoint: Once on the first day and on the fifth to tenth day after discontinuing methadone. Method of measurement: Filling and Calculating Score of Beck Depression or Anxiety Inventory. Calculation of Serum levels of cortisol and oxytocin. Timepoint: Once at the beginning of the first day and the second time at the fourth day after discontinuing methadone. Method of measurement: take of Blood sampling and measurement of cortisol and oxytocin levels by Kit Elisa. Comparison of the effects of oxytocin use in group versus placebo use in group in reducing or increasing the activity of different parts of the brain. Timepoint: Once at the beginning of the first day and the second time at the fourth or fifth day after discontinuing methadone. Method of measurement: Getting fmri brain. Tehran University of Medical Sciences Approved 2017-11-11 Ethics committee of tehran University of Medical Sciences No.7, blind alley2,Navid alley, Nejatollahi st.karimkhanezand st. tehran Tehran Iran (Islamic Republic of)