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IRCT2015103024792N1 IRCT 2016-06-12 Vice chancellor for research Kashan University of Medical Sciences Evaluation of Oxytocin,s effect in comparison with placebo on craving; withdrawal and stress response due to heroin. To determine the effect of Oxytocin in compared with placebo on craving; withdrawal and stress response in heroin dependents. 2015-10-23 anticipated 50 Complete https://irct.ir/trial/20862 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Double blind is related to two groups: subject and investigator. 2 Condition 1: Withdrawal syndrome. Condition 2: Craving. Intervention 1: Group1: one time 40 IUs intranasal Oxytocin(Pitocin ) from NOVARTIS company. Intervention 2: Group2 : one time 40 IUs intranasal saline.
public Mina Moeini
Department of Addiction studies, School of Medicine, Kashan University of Medical Sciences , Ravandi Blvd . Kashan
Isfahan Iran (Islamic Republic of) 8168753513 +98 31 3669 1079 Drm_moeini@yahoo.com Kashan University of Medical Sciences scientific Hamid Reza Banafshe
Department of Pharmacology, School of Medicine, kashan University of Medical Sciences
kashan Iran (Islamic Republic of) +98 31 5554 0021 banafshe-h@kaums.ac.ir banafshe57@hotmail.com Kashan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Subjects must meet DSM-IV criteria for current heroin dependence ( within the past six months). Subjects must be at the beginning of treatment period and must abstain from heroin for at least three days prior to testing. patients willing to participate in the intervention- The age range of subjects must be between 20 to 60 years old. Subjects must be literate. Exclusion Criteria : Women who are pregnant, nursing or of childbearing potential and positive of pregnancy test. Subjects with evidence of or a history of significant hematological, endocrine, cardiovascular, pulmonary, renal, drug allergy or neurological disease including diabetes, as these conditions may affect physiological/subjective responses. Subjects with Addison's disease, Cushing's disease or other diseases of the adrenal cortex likely to affect hormonal/neuroendocrine status. Subjects with current major depressive disorder, bipolar or post-traumatic stress disorder as these disorders are associated with characteristic changes in stress response. Subjects receiving synthetic glucocorticoid therapy, any exogenous steroid therapy within one month of test session. Subjects taking any psychotropic medications, including SSRI's or other antidepressants, opiates or opiate antagonists as these medicines may affect the test response. Subjects with any acute illness or fever. - positive urine tests indicating abuse of any abuse or stimulant. 20 years 60 years Both F11 F11 Mental and behavioural disorders due to use of opioids Mental and behavioural disorders due to use of opioids Treatment - Drugs Treatment - Drugs Group1: one time 40 IUs intranasal Oxytocin(Pitocin ) from NOVARTIS company Group2 : one time 40 IUs intranasal saline Clinical symptom of withdrawal syndrome of heroin. Timepoint: before and after receiving oxytocin. Method of measurement: clinical opioid withdrawal scale. Clinical opiod craving. Timepoint: before and after receiving oxytocin. Method of measurement: clinical opioid craving scale. Vice chancellor for research Kashan University of Medical Sciences Approved 2015-10-21 Ethics commitee of Kashan University of Medical Sciences School of Medicine , Kashan University of Medical Sciences ,Kashan Kashan Iran (Islamic Republic of)