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IRCT20221022056266N1 IRCT 2022-12-26 Zanjan University of Medical Sciences The effect of Oxytocin with Zinc supplement in treating opiates addiction and improving fertility in Men Evaluating the effect of Oxytocin with Zinc sulphate on the withdrawal symptoms, craving, anxiety and reproductive indices in opiates addicted men under Methadone Maintenance Therapy 2023-01-21 anticipated 40 Complete https://irct.ir/trial/66785 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, using the Random number generation plugin in Excel software, a table of random numbers from 1 to 40 is prepared in a non-sequential and scattered manner, and intervention and control are done by assigning numbers to two groups of 20 people. The randomization process is done by the study consultant, and the clinical researchers do not know about the randomization process, and only randomized codes from 1 to 40 will be provided to them, Blinding description: After selecting the samples, none of the sampled people will know about randomization and the process of allocation to groups. Researchers are given a table of coded numbers in advance, and patients are included in the study in the order of the numbers in the table. Therefore, the present study is double-blind. Oxytocin spray, zinc sulfate capsule, and placebo are both identical in shape, color, and size, and are delivered to the patient in a package. 3 Dependence on opioids. Intervention 1: Control group: A sample of 20 people will be the control group, who will receive oxytocin spray placebo and zinc sulfate placebo for fourteen days. Intervention 2: Intervention group: A sample of twenty people will be the intervention group, who will receive oxytocin nasal spray and zinc sulfate capsules for fourteen days.The intervention group will receive 40 international units of oxytocin nasal spray and one 220 mg zinc sulfate capsule daily. Yes - There is a plan to make this available What will be shared: The data should be such that they do not need additional explanation When: Access starts six months after results are published To whom: The data will be available only to researchers working in academic and scientific institutions. Conditions: It will be available to researchers in academic and scientific institutions for the purpose of research development. Where to obtain: A journal that works in the field of addiction and will accept the publication of research articles How to obtain: According to the rules of the journal Comments:
public Ehsan Sabouri
Dr. Beheshti Hospital, Arg Square, Zanjan
Zanjan Iran (Islamic Republic of) ۴۵۱۳۶۱۵۸۷۷ +98 24 3354 4001 saboory@zums.ac.ir Zanjan University of Medical Sciences scientific Ehsan Sabouri
Dr. Beheshti Hospital, Arg Square, Zanjan
Zanjan Iran (Islamic Republic of) ۴۵۱۳۶۱۵۸۷۷ +98 24 3354 4001 saboory@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) According to the DSM-5, a person must qualify for opioid dependence The patient is being treated with methadone maintenance and is stabilized on it The patient must give written consent to participate in the intervention People participating in the intervention must be male and between 20 and 50 years old and must be literate 20 years 50 years Male Having suicidal thoughts History of any kind of blood disease, glandular disease, heart disease, lung disease, kidney disease, drug sensitivity, diabetes People with major depressive disorder People receiving glucocorticoid treatment in the last month People receiving serotonergic therapy or other antidepressants F00–F99 withdrawal symptoms, Craving, Anxiety, Opiate Addicted men, Fertility Placebo Treatment - Drugs Control group: A sample of 20 people will be the control group, who will receive oxytocin spray placebo and zinc sulfate placebo for fourteen days. Intervention group: A sample of twenty people will be the intervention group, who will receive oxytocin nasal spray and zinc sulfate capsules for fourteen days.The intervention group will receive 40 international units of oxytocin nasal spray and one 220 mg zinc sulfate capsule daily. Oxytocin. Timepoint: Before and after the intervention and two months later for follow-up. Method of measurement: Hormonology. Zinc. Timepoint: Before and after the intervention and two months later for follow-up. Method of measurement: Measurement of zinc level in blood. Clinical Opiate Withdrawal Scale. Timepoint: Before and after the intervention and two months later for follow-up. Method of measurement: Through the checklist for withdrawal symptoms:For each item, circle the number that best describes the patient' s signs or symptom. Craving. Timepoint: Before and after the intervention and two months later for follow-up. Method of measurement: Desire for Drug Questionnaire. Stress. Timepoint: Before and after the intervention and two months later for follow-up. Method of measurement: Depression- Anxiety- Stress Scale. Anxiety. Timepoint: Before and after the intervention and two months later for follow-up. Method of measurement: Depression- Anxiety- Stress Scale. Depression. Timepoint: Before and after the intervention and two months later for follow-up. Method of measurement: Depression- Anxiety- Stress Scale. Testosterone. Timepoint: Before and after the intervention and two months later for follow-up. Method of measurement: Hormonology. Spermogram. Timepoint: Before and after the intervention and two months later for follow-up. Method of measurement: In the Spermogram, two characteristics of semen are considered: 1- Macroscopic characteristics 2- Microscopic characteristics Macroscopic characteristics of semen including color, transparency, concentration of hydrogen ions or pH, volume, duration of closeness, fluidity and viscosity are examined. take The microscopic characteristics of semen include motility, sperm count, viability, sperm morphology, white and red blood cells, and the quality of fructose levels in semen. Zanjan University of Medical Sciences Approved 2022-06-21 Ethics committee of Zanjan University of Medical Sciences Zanjan University of Medical Sciences , Azadi Square, Zanjan, Iran Zanjan Zanjan Iran (Islamic Republic of)