The aim of study is to evaluate the efficacy of oxytocin in treating methamphetamine dependency.
Design
In this research, 50 eligible patients with methamphetamine dependency diagnosis according to DSM-IV criteria will be included. Participants will randomly be divided into two intervention and control groups and each participant will be assigned a code.
Settings and conduct
Among patients with methamphetamine abuse referred to Noor Hospital affiliated to Isfahan University of Medical Sciences, 50 patients will be selected according to inclusion and exclusion criteria. Parallel double-blind (both patients and researchers) randomized controlled clinical trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria: methamphetamine dependency assessed by the substance abuse section of the Structured Clinical Interview of DSM-IV; Patients with Matrix Model treatment; aged 18 to 65 years
Exclusion Criteria: Suicide attempts within the past 12 months; Unwillingness to cooperate in study.
Intervention groups
The first group will receive oxytocin spray 40IU daily for 28 days. The second group will receive placebo for 28 days.
Main outcome variables
Desire for methamphetamine with CCQ-Brief Questionnaire, Depression with Beck Depression Inventory (BDI) and Anxiety with Beck Anxiety Inventory (BAI) will be completed questionnaire weekly. ACTH level and Cortisol also will be evaluated at study baseline, middle and end-of-trial.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171129037673N1
Registration date:2018-01-29, 1396/11/09
Registration timing:registered_while_recruiting
Last update:2018-01-29, 1396/11/09
Update count:0
Registration date
2018-01-29, 1396/11/09
Registrant information
Name
Abbas Azadbakht
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3338 1066
Email address
azadbakht-a@mail.kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-02-19, 1396/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of oxytocin on clinical signs, ACTH & cortisol levels and methamphetamine craving in matrix maintenance treatment
Public title
The Effect of oxytocin on clinical signs, ACTH & cortisol levels and methamphetamine craving in matrix maintenance treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18-65 years old
Male
Methamphetamine dependency as assessed by the substance abuse section of the Structured Clinical Interview of DSM-IV
Being at the Matrix Model of treatment.
Seeking treatment for methamphetamine use
Patients willing to participate in the intervention
Exclusion criteria:
Suicide attempts within the past 12 months; suicidal ideas or psychotic symptoms in the past 6 months determined by a study team physician
Current opioid, alcohol or sedative physical dependence or cocaine dependence
Major cardiovascular disorder
Abnormal liver function
Having severe psychotic disorders
Metabolic diseases such as diabetes
Neurological diseases
Positive urine tests indicating abuse of any substance or stimulant
Unwillingness to participate in the study
Age
From 18 years old to 65 years old
Gender
Male
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment will be done by the use of computer-generated random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, investigators or the assessors of the outcomes are unaware of the study group.
Use of Placebo
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of kashan univetsity of medical sciences
Street address
No.8187695895 , East shahidan Ave.
City
isfahan
Province
Isfehan
Postal code
8187695895
Approval date
2017-11-17, 1396/08/26
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1396.62
Health conditions studied
1
Description of health condition studied
Drug abuse
ICD-10 code
Z71.5
ICD-10 code description
Drug abuse counseling and surveillance
Primary outcomes
1
Description
Measure of desire for methamphetamine
Timepoint
Complete questionnaire weekly
Method of measurement
CCQ-Brief Questionnaire
2
Description
Depression beck score
Timepoint
Complete questionnaire weekly
Method of measurement
Questionnaire
3
Description
Anxiety beck score
Timepoint
Complete questionnaire weekly
Method of measurement
Questionnaire
4
Description
ACTH level in the blood plasma
Timepoint
Before, middle and end of study
Method of measurement
Blood screening
5
Description
Cortisol level in the blood plasma
Timepoint
Before, middle and end of study
Method of measurement
Blood screening
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Participants will receive oxytocin nasal spray, 10IU/spray, twice a day until 28 days. (One dose in each nostril (40IU daily))
Category
Treatment - Drugs
2
Description
Control group: One time 40 IU intranasal saline
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Noor hospital
Full name of responsible person
Abbas Azadbakht
Street address
Ostandari Ave.
City
Isfahan
Province
Isfehan
Postal code
8187695895
Phone
+98 31 3338 1066
Email
abasazadbakht@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 2999
Email
hamidi_gh@kaums.ac.ir
Grant name
Vice chancellor for research, Kashan University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Abbas Azadbakht
Position
Ph.D. student
Latest degree
Medical doctor
Other areas of specialty/work
Addiction Studies
Street address
No. 8187695895, East Shahidan
City
Isfahan
Province
Isfehan
Postal code
8187695895
Phone
+98 31 3338 1066
Fax
Email
azadbakht-a@mail.kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Abbas Azadbakht
Position
Ph.D. student
Latest degree
Medical doctor
Other areas of specialty/work
Addiction Studies
Street address
No. 8187695895, East Shahidan
City
Isfahan
Province
Isfehan
Postal code
8187695895
Phone
+98 31 3338 1066
Fax
Email
azadbakht-a@mail.kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Abbas Azadbakht
Position
Ph.D. student
Latest degree
Medical doctor
Other areas of specialty/work
Addiction Studies
Street address
No. 8187695895, East Shahidan
City
Isfahan
Province
Isfehan
Postal code
8187695895
Phone
+98 31 3338 1066
Fax
Email
azadbakht-a@mail.kaums.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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All collected deidentified IPD
When the data will become available and for how long
Starting 6 months after publication
To whom data/document is available
For people working in academic institutions and businesses
Under which criteria data/document could be used
The documents will be shared for continuation and being executable of this study
From where data/document is obtainable
Email address
What processes are involved for a request to access data/document
They will be recieved data until two weeks from them email.