The effect of oxytocin in the treatment of methadone maintenance patients

The effect of oxytocin on craving, sleep quality, sexual and thyroid disorders, and the expression of genes involved in drug craving in patients under methadone maintenance treatment

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20231101059923N1

Enrollment

Registered

2023-12-04

Start date

2023-12-16

Completion date

Unknown

Last updated

2024-01-22

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

Conditions

Addiction. Other psychoactive substance related disorders

Interventions

Intervention 1: Intervention group: Oxytocin 40 IU is administered intranasally, once a day for four weeks. Oxytocin spray contains oxytocin powder (Aburaihan Pharmaceutical Company), sterile normal s

Eligibility

Sex/Gender

Male

Age

30 Years to 50 Years

Inclusion criteria

Inclusion criteria: Married men under methadone maintenance treatment between 30 and 50 years of age Having sleep disorder and sexual function assessed through the Diagnostic and Statistical Manual of Mental Disorders or DSM-IV

Exclusion criteria

Exclusion criteria: Unwillingness to cooperate Having severe psychiatric and personality disorders Having chronic physical diseases such as liver and kidney disorders, cardiovascular disorders, etc.

Design outcomes

Primary

Measure	Time frame
Craving. Timepoint: At the beginning of the study and the fourth week of the study. Method of measurement: Desire for Drug Questionnaire (DDQ craving).;Sexual function. Timepoint: At the beginning of the study and the fourth week of the study. Method of measurement: International Index of Erectile Function (IIEF).;Prolactin. Timepoint: At the beginning of the study and the fourth week of the study. Method of measurement: Elisa kit.;Testosterone. Timepoint: At the beginning of the study and the fourth week of the study. Method of measurement: Elisa kit.	—

Measure

Time frame

Craving. Timepoint: At the beginning of the study and the fourth week of the study. Method of measurement: Desire for Drug Questionnaire (DDQ craving).;Sexual function. Timepoint: At the beginning of the study and the fourth week of the study. Method of measurement: International Index of Erectile Function (IIEF).;Prolactin. Timepoint: At the beginning of the study and the fourth week of the study. Method of measurement: Elisa kit.;Testosterone. Timepoint: At the beginning of the study and the fourth week of the study. Method of measurement: Elisa kit.

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Secondary

Measure	Time frame
Sleep Quality. Timepoint: At the beginning of the study and the fourth week of the study. Method of measurement: Pittsburgh Sleep Quality Index (PSQI).;T3 level. Timepoint: At the beginning of the study and the fourth week of the study. Method of measurement: Elisa kit.;T4 level. Timepoint: At the beginning of the study and the fourth week of the study. Method of measurement: Elisa kit.;TSH level. Timepoint: At the beginning of the study and the fourth week of the study. Method of measurement: Elisa kit.;CFos gene expression. Timepoint: At the beginning of the study and the fourth week of the study. Method of measurement: Ratio of gene expression to GAPDH gene expression.;BDNF gene expression. Timepoint: At the beginning of the study and the fourth week of the study. Method of measurement: Ratio of gene expression to GAPDH gene expression.;LncRNA BDNF-AS gene expression. Timepoint: At the beginning of the study and the fourth week of the study. Method of measurement: Ratio of gene expression to GAPDH gene expression.	—

Measure

Time frame

Sleep Quality. Timepoint: At the beginning of the study and the fourth week of the study. Method of measurement: Pittsburgh Sleep Quality Index (PSQI).;T3 level. Timepoint: At the beginning of the study and the fourth week of the study. Method of measurement: Elisa kit.;T4 level. Timepoint: At the beginning of the study and the fourth week of the study. Method of measurement: Elisa kit.;TSH level. Timepoint: At the beginning of the study and the fourth week of the study. Method of measurement: Elisa kit.;CFos gene expression. Timepoint: At the beginning of the study and the fourth week of the study. Method of measurement: Ratio of gene expression to GAPDH gene expression.;BDNF gene expression. Timepoint: At the beginning of the study and the fourth week of the study. Method of measurement: Ratio of gene expression to GAPDH gene expression.;LncRNA BDNF-AS gene expression. Timepoint: At the beginning of the study and the fourth week of the study. Method of measurement: Ratio of gene expression to GAPDH gene expression.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmir Ghaderi

Kashan University of Medical Sciences

gaderiam@yahoo.com+98 31 3457 4191

Outcome results

None listed

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