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IRCT20160417027437N3 IRCT 2023-06-18 Ahvaz University of Medical Sciences Effectiveness of zinc supplementation on the possibility of recurrence of anxiety and depression in opioid dependent patients Investigating the effectiveness of zinc supplementation on the possibility of relapse of anxiety and depression in opioid dependent patients under methadone maintenance treatment. 2023-07-23 anticipated 76 Complete https://irct.ir/trial/70602 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done based on the method of random block permutations. Random sequence generation software is used, which refers to the method used to perform a random sequence on the participants in the study, so that the assigned group is not known before assigning the individual. By using sealed opaque mail envelopes with a random sequence, each of the generated random sequences is recorded on a card and the cards are placed inside the mail envelopes in order. In order to maintain the random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of starting the registration of participants, based on the order in which eligible participants entered the study, one of the envelopes will be opened and the assigned group of that participant will be revealed.Based on the method of the permutation blocks of size 4, individuals are randomly divided into two groups. According to that, there are 2 treatments, for every block a different random order will be prepared. Random table was used as the randomization tool, Blinding description: In this study, the project manager and the patient are unaware of which of the two groups will receive which drug or placebo. Medicines and placebos will be similar in terms of shape, color, smell and taste. 3 Patients dependent on opioids. Intervention 1: Intervention group: In addition to methadone as the main treatment, patients in the intervention group will receive 220 mg zinc sulfate capsules every other day for three months. The dose of this capsule will not change during the study period. This pill will be prepared from Aria Pharmaceuticals. Intervention 2: Control group: In addition to methadone as the main treatment, patients in this group will receive placebo capsules every other day for three months. Medicines and placebos will be similar in terms of shape, color, smell, and taste. This pill will be prepared under the supervision of the Faculty of Pharmacy of Ahvaz University of Medical Sciences. 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 There is no further information
public Amir Ali Moghadam Sadegh
Golestan hospital, Farvardin Blvd, Golestan Ave, Ahvaz Ahvaz
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3374 3038 moghaddam.a@ajums.ac.ir Ahvaz University of Medical Sciences scientific Amir Ali Moghadam Sadegh
Golestan Hospital, Farvardin Blvd, Golestan Ave, Ahvaz Ahvaz
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3374 3038 moghaddam.a@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Age 18 to 60 years Diagnosis of substance abuse disorder based on DSM-V diagnostic criteria Receiving methadone as the only treatment protocol 18 years 60 months Both History of allergy to compounds containing zinc The use of compounds containing zinc and other medicinal supplements before intervention and study Having harmful thoughts to yourself and others F11 Opioid related disorders Treatment - Drugs Treatment - Drugs Intervention group: In addition to methadone as the main treatment, patients in the intervention group will receive 220 mg zinc sulfate capsules every other day for three months. The dose of this capsule will not change during the study period. This pill will be prepared from Aria Pharmaceuticals. Control group: In addition to methadone as the main treatment, patients in this group will receive placebo capsules every other day for three months. Medicines and placebos will be similar in terms of shape, color, smell, and taste. This pill will be prepared under the supervision of the Faculty of Pharmacy of Ahvaz University of Medical Sciences. Anxiety. Timepoint: Before the intervention, one month and three months after the intervention. Method of measurement: Spielberger questionnaire. Depression. Timepoint: Before the intervention, one month and three months after the intervention. Method of measurement: Beck depression questionnaire. Ahvaz University of Medical Sciences Approved 2023-05-27 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Ahvaz, Golestan St., Farvardin Blvd., Jundishapur University of Medical Sciences, Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)