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IRCT20231101059923N2 IRCT 2023-12-16 Kashan University of Medical Sciences Complementary effect of spirulina in the treatment of opioid patients under methadone maintenance treatment The effects of spirulina (Arthrospira platensis) supplementation compared to placebo on craving, mental health, sexual and cognitive function in opioid patients under methadone maintenance treatment 2023-12-22 anticipated 50 Complete https://irct.ir/trial/73743 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, the spirulina group will be coded with the letter A and the placebo group with the letter B, and then using the website www. sealedenvelope.com/simple-randomiser/v1/lists, randomization list will be prepared by selecting a sample size of 50 (two groups of 25) and permuted block randomization method (block size=4). Then, through the obtained randomization list, the subjects included in the study will be assigned to one of the two groups, A or B. For example, suppose that in the first block, the permutation order is ABBA, so the first and fourth samples will be assigned to group A and the second and third samples to group B, and the same will continue until the last sample (25th person), Blinding description: This study is double-blind, and after selecting the samples, none of the sampled people will know about randomization and the allocation process to groups. Patients enter the study based on the randomization list. This study will try to use the placebo similar to the capsules in terms of color, size, and the number of pills for 12 weeks of intervention. The composition of the placebo in the present study is paraffin. In addition, to keeping blind the presenters and patients, pills and placebos are placed in separate vials named with codes 1 and 2. 2 Addiction. Intervention 1: Intervention group: The patient group will be given spirulina supplement and they will consume it for 3 months, the daily dosage is two 500 mg capsules. Intervention 2: Control group: A placebo with the same appearance as spirulina capsules is prescribed for 3 months. 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 To keep patients' information safe, codes will be assigned to patients' data instead of using patients' names. Individual patient data will not be shared without approval from the patient.
public Fatemeh Mehrzad
Kargarnejad Hospital, Ghotbe Ravandi Boulevard
kashan Iran (Islamic Republic of) 87159 88111 +98 31 3457 4191 mehrzad.fateme60@gmail.com Kashan University of Medical Sciences scientific Amir Ghaderi
Faculty of Medicine; Kashan University of Medical Sciences; Qutb Rawandi Blvd.
Kashan Iran (Islamic Republic of) 8715981151 +98 31 3457 4191 gaderiam@yahoo.com Kashan University of Medical Sciences Iran (Islamic Republic of) Consent and informed willingness to participate in research Positive methadone urine test Using methadone for at least one year Married men in the age range of 30-50 years 30 years 50 years Male Suffering from chronic physical diseases including phenyl ketonuria, autoimmune diseases, AIDS, hepatitis, liver and kidney disorders, cardiovascular disorders, etc. at the time of entering the treatment F19 Other psychoactive substance related disorders Treatment - Drugs Placebo Intervention group: The patient group will be given spirulina supplement and they will consume it for 3 months, the daily dosage is two 500 mg capsules. Control group: A placebo with the same appearance as spirulina capsules is prescribed for 3 months. Mental health. Timepoint: At the beginning of the study and the twelfth week of the study. Method of measurement: Depression‚ Anxiety‚ Stress Scale (DASS21). Sexual function. Timepoint: At the beginning of the study and the twelfth week of the study. Method of measurement: International Index of Erectile Function (IIEF). Craving. Timepoint: At the beginning of the study and the twelfth week of the study. Method of measurement: Desire for Drug Questionnaire (DDQ craving). Cognitive function. Timepoint: At the beginning of the study and the twelfth week of the study. Method of measurement: Cattell–Horn–Carroll (CHC) approach. Kashan University of Medical Sciences Approved 2023-10-29 Ethics Committee of Kashan University of Medical Sciences Kashan University of Medical Sciences, Qutb Rawandi Blvd kashan Isfehan Iran (Islamic Republic of)