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)

Evaluation of the effect of omega-3 fatty acids supplements in the treatment of patients with methamphetamine-Induced mood disorder compared with placebo (clinical trial with a control group)

Clinical trials with control group, parallel groups, double-blind, randomized, phase 3, 50 patients

This study is a double-blind trial. The study sample population is consists of all Patients with Methamphetamine-Induced Mood Disorder referring to Farabi Hospital in Kermanshah, that 50 persons will be selected in the available method and randomly will be divided into two groups. In the experimental group, the participants will receive daily 1 capsule of 1000 mg of Omega-3, while the control group 1 capsule of 1000 mg of Placebo daily. All subjects in all two groups will be re-evaluated by completing questionnaires at baseline, 4 weeks and the end of the study (8 weeks after baseline), will be assessed.

Both genders; Methamphetamine-Induced Mood Disorder diagnosed according to Diagnostic and Statistical Manual of Mental Disorders fifth edition by a psychiatrist; Methamphetamine dependence diagnoses accordingly Diagnostic and Statistical Manual of Mental Disorders fifth edition and TLC test; The dominant use of methamphetamine for at least 6 months, lack of serious psychiatric disorders. Patients who are not agree to participate in the study will be excluded.

The group will receive Omega-3 treatment in two months. The daily dose will be 1 capsule of 1000 mg. 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 capsules

relapse, cravings, withdrawal symptoms, depression, mania, anxiety, sleep quality, sexual function, and emotion regulation

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.

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.