Investigation of the effect of rTMS on Amphetamine craving in patients with amphethamine dependency
Design
Two arm parallel groups randomised trial with blinded postoperative care and outcome assessment
The first group: rTMS on DLPFC with 10 Hz frequency for 20 minutes
The second group: rTMS on orbitofrontal with 1 Hz frequency for 20 minutes
Control group: Sham on DLPFC for 20 minutes
Settings and conduct
The study is a double blind clinical trial, and patients will be chosen from the clients of the addiction clinic of the Iranian Psychiatric Hospital . Based on the inclusion and exclusion criteria, the study process will be described for each person and if informed consent is given for participation, he / she will be entered into the study. He / She will be randomly assigned to 3 groups. Two active rtms and the sham group.
Participants/Inclusion and exclusion criteria
Patients who come to MMT center of Iran hospital, Exclusion criteria: Current psychosis, Other substance dependency except for nicotine and caffeine, Contraindication of rTMS
Inclusion criteria: Being right handed, Having DSM-IV criteria of amphethamine dependency, At least two weeks of amphethamine withdrawal
Intervention groups
The first group: rTMS on DLPFC with 10 Hz frequency for 20 minutes
The second group: rTMS on orbitofrontal with 1 Hz frequency for 20 minutes
control group: Sham on DLPFC for 20 minutes
Main outcome variables
Craving
Number of hospitalization in past 6 months
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180630040291N1
Registration date:2019-09-09, 1398/06/18
Registration timing:registered_while_recruiting
Last update:2019-09-09, 1398/06/18
Update count:0
Registration date
2019-09-09, 1398/06/18
Registrant information
Name
Atefeh Ghanbari Jolfaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6651 9519
Email address
Ghanbari.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of rTMS on amphetamine craving in patients with amphethamine dependency
Public title
The effect of rTMS on Amphetamine craving
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being right handed, Having DSM-IV criteria of amphethamine dependency, At least two weeks of amphethamine withdrawal; Having amphethamine craving
Exclusion criteria:
Current psychosis, Other substance dependency except for nicotine and caffeine, Contraindication of rTMS, Recent change of medication in past two weeks
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Restricted randomization based on random allocation rule
Blinding (investigator's opinion)
Double blinded
Blinding description
Using sham coil
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciencs
Street address
Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-01-15, 1396/10/25
Ethics committee reference number
IR.IUMS.REC 1396.31287
Health conditions studied
1
Description of health condition studied
Amphethamine craving
ICD-10 code
F19.1
ICD-10 code description
Other psychoactive substance abuse
Primary outcomes
1
Description
Amphetamine craving
Timepoint
Before rTMS and at least 1 week after the end of rTMS
Method of measurement
VAS Visual cue_indused craving assessment
Secondary outcomes
1
Description
Number of hospitalizations
Timepoint
Six months after rTMS
Method of measurement
Counting
Intervention groups
1
Description
Intervention group: The patients will be selected among clients referring to the addiction clinic (MMT) of Tehran Psychiatric Hospital and Tehran Behavioral Sciences Institute, and Iran's Psychiatric Center using convenient sampling method. The research inclusion criteria included 1- People aged 18 to 60 years who have the amphetamines dependence criteria based on DSM-V before the treatment and have undergone treatment and have not used amphetamine at least for 2 weeks 2- The patient report the methamphetamine craving. Exclusion criteria included: Current psychosis, Other substance dependency except for nicotine and caffeine, Contraindication of rTMS, Recent change of medication in past two weeks
Category
Treatment - Devices
2
Description
Intervention group: The patients will be selected among clients referring to the addiction clinic (MMT) of Tehran Psychiatric Hospital and Tehran Behavioral Sciences Institute, and Iran's Psychiatric Center using convenient sampling method. The research inclusion criteria included 1- People aged 18 to 60 years who have the amphetamines dependence criteria based on DSM-V before the treatment and have undergone treatment and have not used amphetamine at least for 2 weeks 2- The patient report the methamphetamine craving.Exclusion criteria included: Current psychosis, Other substance dependency except for nicotine and caffeine, Contraindication of rTMS, Recent change of medication in past two weeks
Category
Treatment - Devices
3
Description
Control group: The patients will be selected among clients referring to the addiction clinic (MMT) of Tehran Psychiatric Hospital and Tehran Behavioral Sciences Institute, and Iran's Psychiatric Center using convenient sampling method. The research inclusion criteria included 1- People aged 18 to 60 years who have the amphetamines dependence criteria based on DSM-V before the treatment and have undergone treatment and have not used amphetamine at least for 2 weeks 2- The patient report the methamphetamine craving. Exclusion criteria included: Current psychosis, Other substance dependency except for nicotine and caffeine, Contraindication of rTMS, Recent change of medication in past two weeks
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran Psychiatric Hospital
Full name of responsible person
Atefeh Ghanbari
Street address
Old road of Karaj
City
Tehran
Province
Tehran
Postal code
1398913151
Phone
+98 21 4450 3395
Email
iph@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Atefeh Ghanbari Jolfaei
Street address
Hemmat highway
City
Tehran
Province
Tehran
Postal code
14496144565
Phone
+98 21 8862 2674
Email
adminsite@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Atefeh Ghanbari Jolfaei
Position
Associate professor of psychiatry
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Rasoul akram hospital, Niayesh St.
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6651 9519
Fax
Email
draghj@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Atefeh Ghanbari Jolfaei
Position
Associate professor of psychiatry
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Rasoul akram hospital, Niayesh St.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6651 9519
Fax
Email
draghj@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Atefeh Ghanbari Jolfaei
Position
Associate professor of psychiatry
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Rasoul akram hospital, Niayesh St.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6651 9519
Fax
Email
draghj@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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Original article
When the data will become available and for how long
At the end of the project
To whom data/document is available
The readers of the journal in which the article will be accepted
Under which criteria data/document could be used
Guideline of the journal
From where data/document is obtainable
It is not determined yet
What processes are involved for a request to access data/document