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Evaluation of Oxytocin,s effect in comparison with placebo on craving; withdrawal and stress response due to heroin.

To determine the effect of Oxytocin in compared with placebo on craving; withdrawal and stress response in heroin dependents.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015103024792N1
Enrollment
50
Registered
2016-06-12
Start date
2015-10-23
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Condition 1: Withdrawal syndrome. Condition 2: Craving. Mental and behavioural disorders due to use of opioids Mental and behavioural disorders due to use of opioids

Interventions

Intervention 1: Group1: one time 40 IUs intranasal Oxytocin(Pitocin ) from NOVARTIS company. Intervention 2: Group2 : one time 40 IUs intranasal saline.
Treatment - Drugs
Group1: one time 40 IUs intranasal Oxytocin(Pitocin ) from NOVARTIS company
Group2 : one time 40 IUs intranasal saline

Sponsors

Vice chancellor for research Kashan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Subjects must meet DSM-IV criteria for current heroin dependence ( within the past six months). Subjects must be at the beginning of treatment period and must abstain from heroin for at least three days prior to testing. patients willing to participate in the intervention- The age range of subjects must be between 20 to 60 years old. Subjects must be literate. Exclusion Criteria : Women who are pregnant, nursing or of childbearing potential and positive of pregnancy test. Subjects with evidence of or a history of significant hematological, endocrine, cardiovascular, pulmonary, renal, drug allergy or neurological disease including diabetes, as these conditions may affect physiological/subjective responses. Subjects with Addison's disease, Cushing's disease or other diseases of the adrenal cortex likely to affect hormonal/neuroendocrine status. Subjects with current major depressive disorder, bipolar or post-traumatic stress disorder as these disorders are associated with characteristic changes in stress response. Subjects receiving synthetic glucocorticoid therapy, any exogenous steroid therapy within one month of test session. Subjects taking any psychotropic medications, including SSRI's or other antidepressants, opiates or opiate antagonists as these medicines may affect the test response. Subjects with any acute illness or fever. - positive urine tests indicating abuse of any abuse or stimulant.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Clinical symptom of withdrawal syndrome of heroin. Timepoint: before and after receiving oxytocin. Method of measurement: clinical opioid withdrawal scale.

Secondary

MeasureTime frame
Clinical opiod craving. Timepoint: before and after receiving oxytocin. Method of measurement: clinical opioid craving scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMina Moeini

Kashan University of Medical Sciences

Drm_moeini@yahoo.com+98 31 3669 1079

Outcome results

None listed

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