| CTRI Number |
CTRI/2025/06/089450 [Registered on: 24/06/2025] Trial Registered Prospectively |
| Last Modified On: |
23/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [alpha tACS (Transcranial alternating current stimulation )] |
| Study Design |
Other |
|
Public Title of Study
|
Therapeutic Effect of Alpha tACS (Transcranial alternating current stimulation) over Left Dorsolateral Prefrontal Cortex on cue-related Craving in Patients with Cannabis Dependence Syndrome |
|
Scientific Title of Study
|
Effect Of alpha Transcranial alternating current stimulation (tACS) over Left Dorso lateral pre frontal cortex (DLPFC) on cue related Craving in Patients with Cannabis Dependence Syndrome: An ERP-Based Sham-Controlled Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vidhit Baswani |
| Designation |
Junior Resident, Psychiatry |
| Affiliation |
CIP , KANKE . RANCHI |
| Address |
Central Institute of Psychiatry, KANKE, RANCHI, Jharkhand, India 834006.
Ranchi
JHARKHAND
834006
India |
| Phone |
07984550345 |
| Fax |
|
| Email |
drvidhit@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr ANIRUDDHA MUKHERJEE |
| Designation |
Professor, Department of Psychiatry |
| Affiliation |
CIP , KANKE . RANCHI |
| Address |
Central Institute of Psychiatry, Ranchi
Ranchi
JHARKHAND
834006
India
Central Institute of Psychiatry, Ranchi
Ranchi
JHARKHAND
834006
India
Ranchi
JHARKHAND
834006
India |
| Phone |
9474413598 |
| Fax |
|
| Email |
dr_aniruddha@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr UMESH S MD |
| Designation |
Associate Professor, Department of Psychiatry |
| Affiliation |
CIP , KANKE . RANCHI |
| Address |
Central Institute of Psychiatry, Ranchi
Ranchi
JHARKHAND
834006
India
Central Institute of Psychiatry, Ranchi
Ranchi
JHARKHAND
834006
India
Ranchi
JHARKHAND
834006
India |
| Phone |
9771702403 |
| Fax |
|
| Email |
umesh.yes@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Central Institute of Psychiatry,
Ranchi
JHARKHAND
834006
India |
|
|
Primary Sponsor
|
| Name |
Central institute of psychiatry, Ranchi |
| Address |
CENTRAL INSTITUTE OF PSYCHIATRY
RANCHI, JHARKHAND 834006
|
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vidhit Baswani |
Central Institute of Psychaitry |
KS Mani CCN
Lab,Psychiatry
Department,Central
Institute Of Psychiatry
Ranchi
JHARKHAND
Ranchi
JHARKHAND |
07984550345
drvidhit@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, CIP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F122||Cannabis dependence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Alpha Transcranial alternating current stimulation (tACS) |
The active group with electrodes will be placed in the left dorsolateral prefrontal cortex (DLPFC) (F3) and the right dorsolateral prefrontal cortex DLPFC (F4) according to the 10-20 system.
Stimulation parameters were set to a current of 2 mA Alpha tACS (10 Hz) will be applied with a session duration of 20 min.
There will be a total of 20 sessions, with 2 sessions each day over 2 weeks.
|
| Comparator Agent |
Sham |
Alpha tACS will be applied for 30 seconds, with electrodes placed in the left dorsolateral prefrontal cortex (DLPFC) (F3) and the right dorsolateral prefrontal cortex DLPFC (F4) according to the 10-20 system, giving an initial sensation of tACS while minimizing stimulatory effects |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
1. Patients diagnosed with disorders due to the use of cannabis dependence (6C41.2) according to ICD-11 CDDR
2. Male
3. Age between 18 and 50 years
4. Ready to give informed consent.
5. Right-handed
|
|
| ExclusionCriteria |
| Details |
1. Any other comorbid substance dependence (excluding caffeine and nicotine) and other psychiatric disorders.
2. Not willing to give informed consent.
3. Any contraindications for undergoing tACS
4. comorbid medical illness
5. Color blindness
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary outcome is a change in craving in patients with cannabis dependence assessed by MCQ.
|
primary outcome assessed after 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| A secondary outcome is a change in cue-related craving from baseline ERP to the end of the ERP session. |
secondary outcome assessed after 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/06/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This randomized, sham-controlled study investigates the effect of alpha transcranial alternating current stimulation (tACS) over the left dorsolateral prefrontal cortex (DLPFC) on cue-induced craving in patients with cannabis dependence syndrome. Thirty male patients (aged 18–50 years) diagnosed using ICD-11 criteria, without comorbid psychiatric disorders (except nicotine/caffeine), major medical illness, or color blindness, were randomized into active (n=15) and sham (n=15) groups. Active tACS involved 10 Hz stimulation at 2 mA using the Starstim 32 device (F3-F4 montage), applied for 20 minutes, twice daily over 2 weeks, while the sham group received identical setup with minimal stimulation. The primary outcomes were changes in craving measured by the Marijuana Craving Questionnaire and neural responses assessed using mismatch negativity (MMN) components of Event-Related Potentials (ERP). Secondary assessments included the Hamilton Anxiety Rating Scale, Brief Psychiatric Rating Scale, and Addiction Severity Index, with additional analysis of correlations with socio-demographic factors. The study aims to evaluate whether alpha tACS can modulate craving-related neural activity and reduce subjective craving, offering potential as a non-invasive neuromodulatory treatment for cannabis dependence. |