The effect of zinc supplements on the oxidative stress and reduction of withdrawal symptoms in opioid addicts in the withdrawal syndrome

The effect of zinc supplements on the oxidative stress and reduction of withdrawal symptoms in opioid addicts in the withdrawal syndrome

This study is a phase 3 clinical trial with control group, with parallel groups, three blind, randomized, with a volume of 40 samples.

After diagnostic and clinical interview by psychiatrist in psychiatry department as well as diagnostic criteria for drug dependence based on DSM-5 at Hamadan Sina Farshchian Hospital, peripheral blood of studied subjects after obtaining consen, were taken to measurement of serum antioxidant capacity, serum level of malondialdehyde, serum thiol groups, activity of glutathione peroxidase and superoxide dismutase enzymes.

Inclusion criteria include opioid use for two years or more, hospitalization for up to one week from the time of withdrawal, no medication without clinical expertise, absence of acute and chronic inflammatory diseases, and any acute or chronic infections. Other and no mention of AIDS, hepatitis and diabetes.

In general, two intervention and control groups will participate in this study. Subjects in the intervention group use 30 mg zinc tablets. In the control group, a placebo zinc pill form and color is used.

Oxidative stress factors, reduction of withdrawal symptoms

For this purpose we will use quadratic random blocks method. For this purpose, we provide four sheets of paper for each drug and placebo group separately. We write on two sheets of letter A (intervention group) and on the other two sheets of letter C (comparison group). Mix the sheets together and place in a drawer. By referring to each eligible patient, one sheet was randomly drawn and the A or C sheet was drawn according to one of the two groups (zinc recipient) and control group Will be allocated. It should be noted that the drawn sheets will not be returned to the drawer until all four sheets have been drawn. Once the four sheets have been randomly pulled out, all the sheets are returned to the drawer and the procedure will be repeated for the next four patients until the desired sample size is reached.

Patients in the intervention group received 30 mg zinc pills without awareness. The other group uses medication that is a form and color with zinc tablets. Also, the treating physician who will examine patients will not be aware of the type of medication used for patients. In addition, the statistical analyst will not be aware of the drug code used. Therefore, this study will be a triple blind.