Evaluation of the additive effect of transcranial direct current stimulation (tDCS)and Haboshefa in combination with conventional non-pharmacological therapies in reducing the temptation ,improvement of cognitive ability and stress in cannabis users.
Evaluation of the additive effect of transcranial direct current stimulation (tDCS)and Haboshefa in combination with conventional non-pharmacological therapies in reducing the temptation ,improvement of cognitive ability and stress in cannabis users.
Design
Randomized clinical trial with control group ,double blinded ,sham and placebo group beside real intervention , randomization executed with last number of national code.
Settings and conduct
Each patient randomly assigned to one group in depend on last number of national code .All patient with even number assigned to group A which receive standard therapy with TDCS.In this group we have two equal sub group received real TDCS therapy and sham TDCS therapy .Only the TDCS operator knows the real and sham and coding them means it remains blind to research team and the operator will not inform about patient follow up condition and psychological state which means double blind the research .Group B receive standard therapy with habolshafa capsules.In this group two sub group of real drug and placebo present which is blinded for research team and coded in sahed university.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1-History of cannabis abuse for at least 6 months besides having the DSM-5 criteria of cannabis abuse disorder
2-Absence of any severe psychiatric comorbidity including schizophrenia -bipolar mood disorder
3- Age between 20 to 40
4-Male gender
Exclusion criteria:
1-Having other medical conditions such as Diabetes ,Hypertension ,Malignancy
2-Other substance abuse
Intervention groups
First intervention group received TDCS procedure (Half real and half sham TDCS) in addition to standard therapy.
Second intervention group received Habolshafa capsules (Half real capsules and half placebo capsules ) in addition to standard therapy.
Main outcome variables
craving - memory - depression
General information
Reason for update
Acronym
کانابیس
IRCT registration information
IRCT registration number:IRCT20220823055784N1
Registration date:2022-09-12, 1401/06/21
Registration timing:prospective
Last update:2022-09-12, 1401/06/21
Update count:0
Registration date
2022-09-12, 1401/06/21
Registrant information
Name
yasha fayaz faizy
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3221 9703
Email address
dr_yasha_fayaz@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2023-02-20, 1401/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the additive effect of transcranial direct current stimulation (tDCS)and Haboshefa in combination with conventional non-pharmacological therapies in reducing the temptation ,improvement of cognitive ability and stress in cannabis users.
Public title
Evaluation of the additive effect of transcranial direct current stimulation (tDCS)and Haboshefa in combination with conventional non-pharmacological therapies in reducing the temptation ,improvement of cognitive ability and stress in cannabis users.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Presence of cannabis abuse criteria at least for 6 months
Absence of any other obvious psychiatric disorder such as bipolar or etc.
Age between 20 and 40
Male gender
Exclusion criteria:
Presence of underlying medical disease such as diabetes or malignancy or hypertension
Any other drug abuse
Age
From 20 years old to 40 years old
Gender
Male
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
If the last number of national code (identity number) is odd ,The patient will be in the TDCS group; And if it is even the patient will be in habolshafa group
Blinding (investigator's opinion)
Double blinded
Blinding description
The drug packs are coded in two forms of real drug and placebo in the Shahed university, And the investigation team is not informed about the codes.
In the TDCS group the patients are coded in two groups and only the operator has the information about the codes.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ّIran university medical ethic comitee
Street address
No.31 bakhshdari ave.,thaleghani street ,karaj
City
karaj
Province
Alborz
Postal code
۳۱۵۵۶۶۶۴۷۳
Approval date
2022-03-04, 1400/12/13
Ethics committee reference number
ir.iums.rec.1400.1147
Health conditions studied
1
Description of health condition studied
cannabis abuse
ICD-10 code
F12.1
ICD-10 code description
Cannabis abuse
Primary outcomes
1
Description
Craving
Timepoint
Start and end of study
Method of measurement
MCQ
2
Description
Memory
Timepoint
Start and end of study
Method of measurement
Wechsler memory exam
3
Description
Depression
Timepoint
Start and end of study
Method of measurement
Hamilton depression exam
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: TDCS procedure perform in 20 session with standard protocol of craving reduction in DLPFC .Half patient receive real TDCS and other half sham TDCS .In this method single canal stimulation which Anod placed in F3 region and Cathod placed in F4 region is performed by previous studies .Duration of each session is 20 minutes and 2 MA stimulation will perform if tolarated.2 outpatient session each week present beside of standard psychological thrapy.Urine test perform weekly for cannabis depend on it`s halflife.
Category
Treatment - Devices
2
Description
Intervention group2 :Receive Habolshafa capsules weekly and consume 3 capsules per day each 8 hour .Drug packs contains 21 capsules each week .Real and placebo capsules coded in Shahed university without information to patient and research team .Duration of treatment is 12 week according to previous studies .Each week patients examined for drug adverse effect and urine cannabis test by the research team.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Doctor fayaz drug abuse treatment center
Full name of responsible person
yasha fayaz faizy
Street address
No.31 ,bakhshdari ave.,taleghani st.,karaj
City
karaj
Province
Alborz
Postal code
۳۱۵۵۶۶۶۴۷۳
Phone
+98 26 3221 9703
Fax
+98 26 3221 9704
Email
dr_yasha_fayaz@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Doctor naseri
Street address
North kargar
City
Tehran
Province
Tehran
Postal code
۴۴۳۱۵۵۶۷۳
Phone
+98 21 8835 4471
Email
dr_yasha_fayaz@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Habolshafa capsules
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
Iran University of Medical Sciences
Full name of responsible person
ِYasha fayaz faizy
Position
Phd candidate
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
No.31 ,bakhshdari ave,karaj
City
Karaj
Province
Alborz
Postal code
۳۱۵۵۶۶۶۴۷۲
Phone
+98 26 3221 9703
Email
dr_yasha_fayaz@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Yasha fayaz faizy
Position
Phd candidate
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
No.31 , bakhshdari ave,karaj
City
Karaj
Province
Alborz
Postal code
۳۱۵۵۶۶۶۴۷۳
Phone
+98 26 3221 9703
Email
dr_yasha_fayaz@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Yasha fayaz faizy
Position
Phd candidate
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
No31.,bakhshdari ave., karaj
City
Karaj
Province
Alborz
Postal code
۳۱۵۵۶۶۶۴۷۳
Phone
+98 26 3221 9703
Email
dr_yasha_fayaz@yahoo.com
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
Not applicable
Title and more details about the data/document
data will be published after making undetectable
When the data will become available and for how long
from 1402
To whom data/document is available
research center of universities
Under which criteria data/document could be used
data analysis allowed
From where data/document is obtainable
dr_yasha_fayaz@yahoo.com
yasha fayaz faizy
What processes are involved for a request to access data/document
after submitting email , the answer posted after about 30 days