The present clinical trial is a randomized, double blind, placebo-controlled study. It is designed to study the possible effects of Oxytocin nasal spray on withdrawal syndrome, craving and response to stress in heroin dependents in the beginning of the treatment period. The people will be divided randomly into two groups based Permuted Block Randomization methods on 4 and 6 blocked. According to the double-blind method, the intervention group will receive a random package, containing oxytocin spray ;and the control group will receive the placebo in similar package and special code. The study will be conducted on two randomized groups of patients (male and female) including 25 people aged between 20 to 60 who meet DSM-IV criteria for heroin dependency in their beginning of treatment. Patients in the first group (drug takers) will receive Oxytocin nasal spray (40 IUs) and the control group will receive placebo (saline) only for one time. Duration of the study on each patient is 6 hours and patients would be excluded from the study if they show positive urine tests of abuse of any narcotic drugs or stimulants. Symptoms of heroin dependence (such as craving, withdrawal syndrome, response to stress ) will be measured before and after Oxytocin nasal spray administration and getting stress (viewing some pictures with neutral content or illegal drug or its tools and emotional pictures ). Craving will be measured by the heroin Craving questionnaire, Go/No-Go task and Stroop task. Withdrawal symptoms will be measured by the Opiate withdrawal symptoms checklist. Stress will be measured by measuring blood Cortisol and the check list for stress.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015103024792N1
Registration date:2016-06-12, 1395/03/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-06-12, 1395/03/23
Registrant information
Name
Mina Moeini
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3669 1079
Email address
Drm_moeini@yahoo.com
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2016-09-20, 1395/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To determine the effect of Oxytocin in compared with placebo on craving; withdrawal and stress response in heroin dependents.
Public title
Evaluation of Oxytocin,s effect in comparison with placebo on craving; withdrawal and stress response due to heroin.
Purpose
Treatment
Inclusion/Exclusion 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.
Age
From 20 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Double blind is related to two groups: subject and investigator
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Kashan University of Medical Sciences
Street address
School of Medicine , Kashan University of Medical Sciences ,Kashan
City
Kashan
Postal code
Approval date
2015-10-21, 1394/07/29
Ethics committee reference number
IR. KAUMS. REC. 1394. 87
Health conditions studied
1
Description of health condition studied
Withdrawal syndrome
ICD-10 code
F11
ICD-10 code description
Mental and behavioural disorders due to use of opioids
2
Description of health condition studied
Craving
ICD-10 code
F11
ICD-10 code description
Mental and behavioural disorders due to use of opioids
Primary outcomes
1
Description
clinical symptom of withdrawal syndrome of heroin
Timepoint
before and after receiving oxytocin
Method of measurement
clinical opioid withdrawal scale
Secondary outcomes
1
Description
clinical opiod craving
Timepoint
before and after receiving oxytocin
Method of measurement
clinical opioid craving scale
Intervention groups
1
Description
Group1: one time 40 IUs intranasal Oxytocin(Pitocin
) from NOVARTIS company
Category
Treatment - Drugs
2
Description
Group2 : one time 40 IUs intranasal saline
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Khaboshani center
Full name of responsible person
Ali Amini
Street address
Shahid Khaboshani center. West jelvan Ave. Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
School of Medicine .Kashan University of Medical Sciences .
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mina Moeini
Position
Ph.D. in addiction studies
Other areas of specialty/work
Street address
Department of Addiction studies, School of Medicine, Kashan University of Medical Sciences , Ravandi Blvd . Kashan
City
Isfahan
Postal code
8168753513
Phone
+98 31 3669 1079
Fax
Email
Drm_moeini@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamid Reza Banafshe
Position
Ph.D. in Pharmacology
Other areas of specialty/work
Street address
Department of Pharmacology, School of Medicine, kashan University of Medical Sciences
City
kashan
Postal code
Phone
+98 31 5554 0021
Fax
Email
banafshe-h@kaums.ac.ir banafshe57@hotmail.com
Web page address
http://medicine.kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mina Moeini
Position
Ph.D. in Addiction studies
Other areas of specialty/work
Street address
Department of Addiction studies, School of Medicine, Kashan University of Medical Sciences .Kashan
City
Kashan
Postal code
8168753513
Phone
+98 31 3669 1079
Fax
Email
drm_moeini@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)