Investigating the therapeutic effect of transcranial direct current stimulation on cannabis craving in adolescents
Design
A randomized, three-way blind, controlled clinical trial on 40 patients. Block randomization was used for randomization.
Settings and conduct
A total of 40 patients aged 12 to 18 years, referred to Beheshti Hospital in Zanjan with cannabis use disorder, were divided into two main groups and a control group.. In the main group, each individual receives 12 sessions of transcranial direct current stimulation with a 2 mA anodic current on the right dorsolateral prefrontal cortex and a cathodic current on the left dorsolateral prefrontal cortex. The control group receives sham transcranial direct current stimulation.
The therapist and the patient are unaware of the type of stimulation, and only the device operator is aware of this.
Participants/Inclusion and exclusion criteria
Entry criteria
-Patients diagnosed with cannabis use disorder
-People aged 12 to 18
-Individuals who have completed an informed consent form or have had informed consent obtained from their parents or guardians.
-Individuals should not receive any medication during treatment.
-In the case of multi substance abuse, the main substance used should be cannabis.
Non-entry criteria:
- Simultaneous diagnosis of any psychiatric illness based on the Diagnostic and Statistical Manual of Mental Disorders 5
- Neurological illnesses such as seizures and strokes and brain disease
- Presence of metal implants
- Physical illness such as oppositional defiant disorder and malignancy or unstable medical conditions
Intervention groups
40 patients diagnosed with cannabis use disorder will be divided into two groups of 20. The first group will receive active transcranial direct current stimulation and the second group will receive a sham type.
Main outcome variables
Cannabis craving will be examined as the main variable.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250913067227N1
Registration date:2025-10-05, 1404/07/13
Registration timing:registered_while_recruiting
Last update:2025-10-05, 1404/07/13
Update count:0
Registration date
2025-10-05, 1404/07/13
Registrant information
Name
Saeedeh Sotudehiean
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 911 391 3882
Email address
ssotudehiean@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-09-22, 1404/06/31
Expected recruitment end date
2025-11-06, 1404/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of transcranial direct current stimulation (tDCS) on craving of cannabis use in teenagers
Public title
Effect of transcranial direct current stimulation in cannabis use disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adolescents with cannabis use disorder
Exclusion criteria:
Co-occurrence of other psychiatric disorders
Age
From 12 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization: In which a group of 40 patients is divided into two blocks of 20 and the treatment sequence is organized so that one randomly selected block receives the active form of transcranial direct current stimulation and the other block receives the passive form. This ensures that the sample size for both groups is equal.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, the participants; the principal investigator and supervisor, as well as the data and questionnaire assessors are kept blind. Only the operator of the transcranial direct current stimulation device knows which group (main or control) the participant is in.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Working Group, Zanjan University of Medical Sciences
Street address
Shahid beheshti Hos.,Arg Sq., Zanjan City
City
Zanjan
Province
Zanjan
Postal code
4513956184
Approval date
2024-08-06, 1403/05/16
Ethics committee reference number
IR.ZUMS.REC.1403.121
Health conditions studied
1
Description of health condition studied
Cannabis use disorder
ICD-10 code
F12.90
ICD-10 code description
Cannabis use, unspecified, uncomplicated
Primary outcomes
1
Description
Craving of cannabis use
Timepoint
Craving of cannabis use before and after 12 section of using of trans cranial direct current stimulation
Method of measurement
Desire for Drug Questionnaire
Secondary outcomes
1
Description
Secondary anxiety symptoms
Timepoint
Anxiety symptoms before and after 12 sessions of transcranial direct current stimulation
Method of measurement
Depression and Anxiety and Stress Scale
2
Description
Secondary depression symptoms
Timepoint
Depression symptoms before and after 12 sessions of transcranial direct current stimulation
Method of measurement
Depression and Anxiety and Stress Scale
Intervention groups
1
Description
Intervention group: each individual received 12 sessions of transcranial direct current stimulation with a 2 mA anodic current on the right dorsolateral prefrontal cortex and a cathodic current on the left dorsolateral prefrontal cortex.
Category
Treatment - Devices
2
Description
Control group: They receive artificial transcranial direct current stimulation.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid beheshti hospital
Full name of responsible person
Saeedeh Sotudehiean
Street address
Shahid beheshti hos., Arg Sq., Zanjan City
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 911 391 3882
Email
ssotudehiean@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Mehrdad Hamidi
Street address
Shahid beheshti Hos., Arg Sq., Zanjan City
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 911 391 3882
Email
ssotudehiean@gmail.com
Grant name
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
Saeedeh Sotudehiean
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Shahid beheshti Hos., Arg Sq., Zanjan City
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 911 391 3882
Email
ssotudehiean@gmil.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Saeedeh Sotudehiean
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Shahid beheshti Hos., Arg Sq., Zanjan City
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 911 391 3882
Email
ssotudehiean@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Saeedeh Sotudehiean
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Shahid beheshti Hos., Arg Sq., Zanjan City
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 911 391 3882
Email
ssotudheiean@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available