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Evaluation of nasal oxytocin spray efficacy in cutting methadone in opioids addicted people that have received methadone .

Evaluation of nasal oxytocin spray efficacy in scales of the withdrawal sign and craving and relapse When cutting methadone in opioids addicted people that have received methadone .

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20191003044971N1
Enrollment
60
Registered
2019-11-30
Start date
2019-10-07
Completion date
Unknown
Last updated
2019-12-17

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

Conditions

drug addiction. Mental and behavioural disorders due to use of opioids

Interventions

Intervention 1: Intervention group: Take oxytocin nasal sprays two puffs every 6 hours in groups with targeted group activities. Intervention 2: Intervention group: Taking placebo nasal spray 2 puffs

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: These people are all men. They are between 18 and 55 years old. They have a history of drug addiction, with the drug being discontinued and replaced with methadone. The amount of methadone consumed is between 10 and 100 mg They have been on methadone maintenance therapy for longer than 6 months now on his own offer Or, as the need arises (example with travel abroad, employment or marriage)he wants to cut off methadone consumption. But despite the high tendency to Interruption of methadone has not been able to reduce methadone levels in 14 days Recently, his methadone dose has not changed. This pations were no positive morphine test for the past 3 months.

Exclusion criteria

Exclusion criteria: There is a history of seizures Recent history of brain injury drug abuse in the past 3 months Severe suicidal thoughts with severe depression Severe allergic disease Severe neurological disorders, especially if it causes increased risk of seizure Acute cardiac abnormalities present History of psychotic disorders acute vascular disorders

Design outcomes

Primary

MeasureTime frame
Craving of opioids abuse. Timepoint: Days 2, 3 and 4 after discontinuing methadone. Method of measurement: Self-report based on the ten-point Likert scale.;Withdrawal sign of cutting of methadone. Timepoint: Days 2, 3 and 4 after discontinuing methadone. Method of measurement: Self-report based on the ten-point Likert scale.;Morphine and methadone test result. Timepoint: At the end of each week after discontinuing methadone until the end of the month 4. Method of measurement: Take a morphine and methadone test.

Secondary

MeasureTime frame
Participate in group therapy. Timepoint: End of each week until the end of the fourth month after discontinuing methadone. Method of measurement: Registration of people attending grouptherapy each week by therapist.;Beck Depression and Anxiety Inventory Scale. Timepoint: Once on the first day and on the fifth to tenth day after discontinuing methadone. Method of measurement: Filling and Calculating Score of Beck Depression or Anxiety Inventory.;Calculation of Serum levels of cortisol and oxytocin. Timepoint: Once at the beginning of the first day and the second time at the fourth day after discontinuing methadone. Method of measurement: take of Blood sampling and measurement of cortisol and oxytocin levels by Kit Elisa.;Comparison of the effects of oxytocin use in group versus placebo use in group in reducing or increasing the activity of different parts of the brain. Timepoint: Once at the beginning of the first day and the second time at the fourth or fifth day after discontinuing methadone. Method of measurement: Getting fmri brain.

Countries

Iran (Islamic Republic of)

Contacts

Public Contactshahram naderi mazjin

Tehran University of Medical Sciences

shahramnadery@yahoo.com+98 21 8894 1372

Outcome results

None listed

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