Protocol summary

Study aim
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
Design
In the outpatient treatment center, oxytocin nasal spray and normal saline nasal spray will have similar containers. Zinc sulfate and zinc sulfate placebo will have identical capsules. so that if If you don't refer to it, you can't understand which is real and which is placebo. The therapist and the patient will be unaware of the actual contents of the containers.
Settings and conduct
.At the outpatient treatment center, the people participating in the intervention will receive a coded package that, based on randomization, they have the possibility of being placed in the control or treatment group (coded by a third party), which the therapist and the patient seeker will not be aware of its actual content. They are aware that ultimately the code will determine whether the person received the actual treatment or a placebo
Participants/Inclusion and exclusion criteria
Entry requirements: According to the DSM-5, a person must qualify for opioid dependence be treated with methadone maintenance Have written consent Age between 20 and 50 years and should be literate Non-entry conditions: A person with suicidal thoughts, a history of any kind of blood, glandular, heart, lung, kidney disease, drug sensitivity, diabetes, major depressive disorder Individuals receiving glucocorticoid, serotonergic, or other antidepressant therapy
Intervention groups
The intervention group includes MMT patients who will receive oxytocin nasal spray and zinc sulfate capsules The control group includes MMT patients who will receive saline nasal spray and zinc sulfate capsule placebo
Main outcome variables
oxytocin; zinc; withdrawal ; Craving Stress; anxiety; depression; testosterone; spermogram

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221022056266N1
Registration date: 2022-12-26, 1401/10/05
Registration timing: prospective

Last update: 2022-12-26, 1401/10/05
Update count: 0
Registration date
2022-12-26, 1401/10/05
Registrant information
Name
naser mirzarei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3341 2593
Email address
nasermirzaie52@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2023-05-21, 1402/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
The effect of Oxytocin with Zinc supplement in treating opiates addiction and improving fertility in Men
Purpose
Treatment
Inclusion/Exclusion 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:
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
Age
From 20 years old to 50 years old
Gender
Male
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
First, using the Random number generation plugin in Excel software, a table of random numbers from 1 to 40 is prepared in a non-sequential and scattered manner, and intervention and control are done by assigning numbers to two groups of 20 people. The randomization process is done by the study consultant, and the clinical researchers do not know about the randomization process, and only randomized codes from 1 to 40 will be provided to them.
Blinding (investigator's opinion)
Double blinded
Blinding description
After selecting the samples, none of the sampled people will know about randomization and the process of allocation to groups. Researchers are given a table of coded numbers in advance, and patients are included in the study in the order of the numbers in the table. Therefore, the present study is double-blind. Oxytocin spray, zinc sulfate capsule, and placebo are both identical in shape, color, and size, and are delivered to the patient in a package.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences , Azadi Square, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2022-06-21, 1401/03/31
Ethics committee reference number
IR.ZUMS.REC.1401.096

Health conditions studied

1

Description of health condition studied
Dependence on opioids
ICD-10 code
F00–F99
ICD-10 code description
withdrawal symptoms, Craving, Anxiety, Opiate Addicted men, Fertility

Primary outcomes

1

Description
Oxytocin
Timepoint
Before and after the intervention and two months later for follow-up
Method of measurement
Hormonology

2

Description
zinc
Timepoint
Before and after the intervention and two months later for follow-up
Method of measurement
Measurement of zinc level in blood

Secondary outcomes

1

Description
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.

2

Description
Craving
Timepoint
Before and after the intervention and two months later for follow-up
Method of measurement
Desire for Drug Questionnaire

3

Description
Stress
Timepoint
Before and after the intervention and two months later for follow-up
Method of measurement
Depression- Anxiety- Stress Scale

4

Description
Anxiety
Timepoint
Before and after the intervention and two months later for follow-up
Method of measurement
Depression- Anxiety- Stress Scale

5

Description
Depression
Timepoint
Before and after the intervention and two months later for follow-up
Method of measurement
Depression- Anxiety- Stress Scale

6

Description
Testosterone
Timepoint
Before and after the intervention and two months later for follow-up
Method of measurement
Hormonology

7

Description
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.

Intervention groups

1

Description
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.
Category
Placebo

2

Description
Intervention group: A sample of twenty people will be the intervention group, who will receive oxytocin nasal spray and zinc sulfate capsules for fourteen days.The intervention group will receive 40 international units of oxytocin nasal spray and one 220 mg zinc sulfate capsule daily.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Beheshti Hospital
Full name of responsible person
Nasser Mirzaei
Street address
Dr. Beheshti Hospital , Arg Square
City
Zanjan
Province
Zanjan
Postal code
۴۵۱۳۶۱۵۸۷۷
Phone
+98 24 3354 4001
Fax
+98 24 3354 2403
Email
dr.ghasemi@zums.ac.ir
Web page address
https://beheshti.zums.ac.ir/index.php?slc_lang=fa&sid=306

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Samad Nedri
Street address
Zanjan University of Medical Sciences , Azadi Square
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3342 0651
Fax
+98 24 3342 4770
Email
research@zums.ac.ir
Web page address
https://zums.ac.ir/index.php?slc_lang=en&sid=266
Grant name
From the budget line of the research project of Zanjan University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Ehsan Sabouri
Position
University professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Dr. Beheshti Hospital, Arg Square, Zanjan
City
Zanjan
Province
Zanjan
Postal code
۴۵۱۳۶۱۵۸۷۷
Phone
+98 24 3354 4001
Fax
+98 24 3354 2403
Email
saboory@zums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Ehsan Sabouri
Position
University professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Dr. Beheshti Hospital, Arg Square, Zanjan
City
Zanjan
Province
Zanjan
Postal code
۴۵۱۳۶۱۵۸۷۷
Phone
+98 24 3354 4001
Fax
+98 24 3354 2403
Email
saboory@zums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Ehsan Sabouri
Position
University professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Dr. Beheshti Hospital, Arg Square, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513615877
Phone
+98 24 3354 4001
Fax
+98 24 3354 2403
Email
saboory@zums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The data should be such that they do not need additional explanation
When the data will become available and for how long
Access starts six months after results are published
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
It will be available to researchers in academic and scientific institutions for the purpose of research development.
From where data/document is obtainable
A journal that works in the field of addiction and will accept the publication of research articles
What processes are involved for a request to access data/document
According to the rules of the journal
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