]>
IRCT20150822023705N13 IRCT 2020-11-23 Kermanshah University of Medical Sciences Comparing the effects of Omega-3 Fatty Acids Supplement and Placebo in the treatment Patients with Methamphetamine-Induced Mood Disorder The efficacy of Omega-3 Fatty Acids Supplement in the treatment Patients with Methamphetamine-Induced Mood Disorder compared with placebo in amphetamine Users (clinical trial with a control group) 2020-12-25 anticipated 50 Complete https://irct.ir/trial/52398 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be divided into two equal groups (A and B) based on a randomized ten-block design using random allocation software. To randomly assign 50 patients to the intervention and control groups, five different blocks of 10 different letters A and B, which indicate Omega-3 Fatty Acids Supplement and placebo groups respectively, will be initially created. These blocks then will be numbered from one to ten. In the next step, each of these blocks will be randomly selected by performing lottery using 10 card with letters from 1 to 10 on them. Thus, in each lottery, by selecting a block, a combination of 5 letters of the letters A (Omega-3 Fatty Acids Supplement group) and B (placebo group) will be obtained. At the end of the 10 drawings, after selecting 10 blocks, a total of 50 letters A and B will be obtained. The resulting combination of letters A and B is single, and will be placed in 50 separate and sealed envelopes, respectively. following each patient recourse, an envelope will be opened to determine the group of that patient, Blinding description: The medication and placebo are delivered to the patient without sticking the name of the medication. The doctor is also unaware of the type of drug used in each group. The color and smell of the main drug and placebo are the same. 2 Methamphetamine-Induced Mood Disorder. Intervention 1: Intervention group: The group will receive Omega-3 Fatty Acids Supplement treatment in two months. The daily dose will be 1 capsule of 1000 mg. These capsules will be given to patients without awareness of the patient and the examiner, and the code for each drug will be recorded in the patient's questionnaire. Omega-3 Fatty Acids Supplement will be purchased from Adonis Kish Pharmaceutical Company. Intervention 2: Control group: The control group will receive placebo treatment in two months. Daily drug intake will be 1 capsule of 1000 mg. Placebo capsules in terms of shape, size, color and smell are similar to the Omega-3 Fatty Acids Supplement capsules. 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 more information
public Nona Vaezi
Isar square, Farabi Hospital
Kermanshah Iran (Islamic Republic of) 6719851115 +98 83 3826 4513 Amirvaezi007@yahoo.com Kermanshah University of Medical Sciences scientific Faeze Tatari
Isar square, Farabi Hospital
Kermanshah Iran (Islamic Republic of) 6719851115 +98 83 3826 4513 fztatari37@gmail.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) Methamphetamine dependence diagnoses according to Diagnostic and Statistical Manual of Mental Disorders fifth edition and TLC test Methamphetamine-Induced Mood Disorder diagnoses accordingly Diagnostic and Statistical Manual of Mental Disorders fifth edition by a psychiatrist The dominant use of methamphetamine for at least 6 months Lack of serious psychiatric disorders no limit no limit Both Disagreement to participate in the study F15.94 Other stimulant use, unspecified with stimulant-induced mood disorder Treatment - Drugs Placebo Intervention group: The group will receive Omega-3 Fatty Acids Supplement treatment in two months. The daily dose will be 1 capsule of 1000 mg. These capsules will be given to patients without awareness of the patient and the examiner, and the code for each drug will be recorded in the patient's questionnaire. Omega-3 Fatty Acids Supplement will be purchased from Adonis Kish Pharmaceutical Company. Control group: The control group will receive placebo treatment in two months. Daily drug intake will be 1 capsule of 1000 mg. Placebo capsules in terms of shape, size, color and smell are similar to the Omega-3 Fatty Acids Supplement capsules. Relapse. Timepoint: before intervention- 4 weeks later- 8 weeks later. Method of measurement: relapse Questionnaire. Craving. Timepoint: before intervention- 4 weeks later- 8 weeks later. Method of measurement: craving Questionnaire. Withdrawal symptoms. Timepoint: before intervention- 4 weeks later- 8 weeks later. Method of measurement: withdrawal symptoms Questionnaire. Depression. Timepoint: before intervention- 4 weeks later- 8 weeks later. Method of measurement: depression Questionnaire. Mania. Timepoint: before intervention- 4 weeks later- 8 weeks later. Method of measurement: mania Questionnaire. Anxiety. Timepoint: before intervention- 4 weeks later- 8 weeks later. Method of measurement: anxiety Questionnaire. Sleep quality. Timepoint: before intervention- 4 weeks later- 8 weeks later. Method of measurement: sleep quality Questionnaire. Sexual function. Timepoint: before intervention- 4 weeks later- 8 weeks later. Method of measurement: sexual function Questionnaire. Emotion regulation. Timepoint: before intervention- 4 weeks later- 8 weeks later. Method of measurement: emotion regulation Questionnaire. Kermanshah University of Medical Sciences Approved 2020-11-10 Kermanshah University of Medical Sciences Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences Kermanshah Kermanshah Kermanshah Iran (Islamic Republic of)