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 .
Evaluation of oxytocin spray efficacy in scales of the withdrawal sign, craving and relapse When cutting methadone in opioid addicted people
Design
in a randomized, double-blind, clinical trial With help of random sequencing software, we divide peoples into 4 groups with using block randomization. 60 patients were randomly divided into 4 groups and The efficacy of oxytocin Prescription along with group activities is evaluated for up to 4 months.
Settings and conduct
At an outpatient addiction treatment center, an expert will label oxytocin or saline solution in similar containers. He then gives them to the therapist who is with the patients. The therapist and the patient will be unaware of the actual contents of the dishes.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Daily use of 10 to 100 mg of methadone for longer than 6 months.They tend to cut it but cannot ;
These people are all men and between 18 and 55 years old.
Exclusion criteria: history of Seizure - Head injury history recently - drug abuse in the past 3 months - Severe suicidal thoughts with severe depression - Severe neurological disorders - Acute cardiac abnormalities - psychotic disorders- Severe allergic disease
Intervention groups
Intervention group includes patients treated with MMT.The intervention is: 1. Administeration of oxytocin 2.group activities.
The control group includes patients treated with MMT.intervention is 1-nasal saline and 2-individual interventions.We compared the individuals in the four factorial groups . - Prescribing nasal: 1 oxytocin individually. 2. placebo individually . 3. placebo in group. 4. oxytocin in group
Main outcome variables
craving, withdrawal symptoms, urinary morphine and methadone tests, persistence on Participation in grouptherapy , beck anxiety and depression scale, cortisol and oxytocin serum levels , The rate of blood flow to brain regions in fmri
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191003044971N1
Registration date:2019-11-30, 1398/09/09
Registration timing:registered_while_recruiting
Last update:2019-11-30, 1398/09/09
Update count:0
Registration date
2019-11-30, 1398/09/09
Registrant information
Name
shahram naderi mazjin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8894 1372
Email address
shahramnadery@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-07, 1398/07/15
Expected recruitment end date
2020-01-05, 1398/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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 .
Public title
Evaluation of nasal oxytocin spray efficacy in cutting methadone in opioids addicted people that have received methadone .
Purpose
Treatment
Inclusion/Exclusion 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:
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
Age
From 18 years old to 55 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation software, which is part of the random sequence generation software, We randomly divided the subjects into 4 groups by block randomization method.
Blinding (investigator's opinion)
Double blinded
Blinding description
The monitoring expert will label oxytocin nasal spray or sodium chloride solution in similar containers. He then delivers them to a therapist who will be with the patients. The therapist and the patient will be unaware of the actual contents of the containers.
Placebo
Used
Assignment
Factorial
Other design features
In this study, 60 patients were randomly assigned into 4 groups of 15 each and the efficacy of group oxytocin Prescription was evaluated.In addition, the efficacy of Prescription of oxytocin or placebo is compared with fmri.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of tehran University of Medical Sciences
Street address
No.7, blind alley2,Navid alley, Nejatollahi st.karimkhanezand st.
City
tehran
Province
Tehran
Postal code
1598996711
Approval date
2017-11-11, 1396/08/20
Ethics committee reference number
IR.TUMS.VCR.REC.1396.3933
Health conditions studied
1
Description of health condition studied
drug addiction
ICD-10 code
F11
ICD-10 code description
Mental and behavioural disorders due to use of opioids
Primary outcomes
1
Description
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
2
Description
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
3
Description
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 outcomes
1
Description
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
2
Description
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
3
Description
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
4
Description
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
Intervention groups
1
Description
Intervention group: Take oxytocin nasal sprays two puffs every 6 hours in groups with targeted group activities
Category
Treatment - Drugs
2
Description
Intervention group: Taking placebo nasal spray 2 puffs every 6 hours in groups with targeted group activities
Category
Treatment - Drugs
3
Description
Intervention group: Take oxytocin nasal spray 2 puffs every 6 hours individually
Category
Treatment - Drugs
4
Description
Control group: Take placebo nasal spray 2 puffs every 6 hours individually
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Outpatient Addiction Treatment Center of ahang
Full name of responsible person
shahram naderi mazjin
Street address
no.7, blind alley2, navid alley, nejatollahi st.,
City
tehran
Province
Tehran
Postal code
1598996711
Phone
+98 21 8894 1372
Email
shahramnadery@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
omranmohammad razaghi
Street address
no.88, italia st., ghods st., keshavarz Boulevard
City
tehran
Province
Tehran
Postal code
1417755469
Phone
+98 21 4305 2000
Fax
+98 21 8899 1117
Email
satimpr @tums.ac.ir
Web page address
http://satim.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?