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The effect of Oxytocin with Zinc supplement in treating opiates addiction and improving fertility in Men

Evaluating the effect of Oxytocin with Zinc sulphate on the withdrawal symptoms, craving, anxiety and reproductive indices in opiates addicted men under Methadone Maintenance Therapy

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20221022056266N1
Enrollment
40
Registered
2022-12-26
Start date
2023-01-21
Completion date
Unknown
Last updated
2023-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dependence on opioids. withdrawal symptoms, Craving, Anxiety, Opiate Addicted men, Fertility

Interventions

Intervention 1: Control group: A sample of 20 people will be the control group, who will receive oxytocin spray placebo and zinc sulfate placebo for fourteen days. Intervention 2: Intervention group:

Sponsors

Zanjan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
20 Years to 50 Years

Inclusion criteria

Inclusion criteria: According to the DSM-5, a person must qualify for opioid dependence The patient is being treated with methadone maintenance and is stabilized on it The patient must give written consent to participate in the intervention People participating in the intervention must be male and between 20 and 50 years old and must be literate

Exclusion criteria

Exclusion criteria: Having suicidal thoughts History of any kind of blood disease, glandular disease, heart disease, lung disease, kidney disease, drug sensitivity, diabetes People with major depressive disorder People receiving glucocorticoid treatment in the last month People receiving serotonergic therapy or other antidepressants

Design outcomes

Primary

MeasureTime frame
Oxytocin. Timepoint: Before and after the intervention and two months later for follow-up. Method of measurement: Hormonology.;Zinc. Timepoint: Before and after the intervention and two months later for follow-up. Method of measurement: Measurement of zinc level in blood.

Secondary

MeasureTime frame
Clinical Opiate Withdrawal Scale. Timepoint: Before and after the intervention and two months later for follow-up. Method of measurement: Through the checklist for withdrawal symptoms:For each item, circle the number that best describes the patient' s signs or symptom.;Craving. Timepoint: Before and after the intervention and two months later for follow-up. Method of measurement: Desire for Drug Questionnaire.;Stress. Timepoint: Before and after the intervention and two months later for follow-up. Method of measurement: Depression- Anxiety- Stress Scale.;Anxiety. Timepoint: Before and after the intervention and two months later for follow-up. Method of measurement: Depression- Anxiety- Stress Scale.;Depression. Timepoint: Before and after the intervention and two months later for follow-up. Method of measurement: Depression- Anxiety- Stress Scale.;Testosterone. Timepoint: Before and after the intervention and two months later for follow-up. Method of measurement: Hormonology.;Spermogram. Timepoint: Before and after the intervention and two months later for follow-up. Method of measurement: In the Spermogram, two characteristics of semen are considered: 1- Macroscopic characteristics 2- Microscopic characteristics Macroscopic characteristics of semen including color, transparency, concentration of hydrogen ions or pH, volume, duration of closeness, fluidity and viscosity are examined. take The microscopic characteristics of semen include motility, sperm count, viability, sperm morphology, white and red blood cells, and the quality of fructose levels in semen.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactEhsan Sabouri

Zanjan University of Medical Sciences

saboory@zums.ac.ir+98 24 3354 4001

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026