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Effect of simuLtaneous Exposure to substance based Cues And high-definition transcranial Direct current stimulation (tDCS) in Patients with Cannabis use Disorder

Effect of simuLtaneous cue-Exposure And high-definition transcranial Direct current stimulation (tDCS) in individuals with cannabiS use disorderâ?? A pilot randomized controlled trial - LEADS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/04/041801
Enrollment
48
Registered
2022-04-11
Start date
Unknown
Completion date
Unknown
Last updated
2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F122- Cannabis dependence

Interventions

Intervention1: HD tDCS and exposure to cue: The participants will be given HD tDCS stimulation- anode at Right Dorsolateral prefrontal cortex and will be simultaneously exposed to cues in the form of

Sponsors

PGIMER Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with a diagnosis of moderate to severe cannabis use disorders by Diagnostic and statistical Manual-5 (DSM-5) 2. We will include patients with comorbid other drug or alcohol use disorders as well 3. Providing written informed consent

Exclusion criteria

Exclusion criteria: 1. Patients with neurological disorders like multiple sclerosis, stroke, epilepsy, encephalopathy due to any cause 2. Patients with a history of significant head injury, Brain tumour or any brain surgery 3. Patients with acute psychotic illness, depressive episodes (we will recruite patients in remission) 4. Pregnant and lactating females 5. Any electronic or metal implants

Design outcomes

Primary

MeasureTime frame
Simultaneous cue-exposure and High-Definition transcranial Direct Current Stimulation (HD tDCS) is feasible and has preliminary anticraving effects in individuals with Moderate and Severe Cannabis use disorderTimepoint: baseline During each session just after last session 1 month after intervention

Secondary

MeasureTime frame
To compare the effects of combined cue-exposure and administration of HD t-DCS, administration of only HD t-DCS (exposure to neutral cues), only cue-exposure (with sham HD t-DCS), and sham stimulation (with neutral cues) for reduction of craving for cannabis, reduction of the frequency of cannabis use, duration of use, and abstinenceTimepoint: Baseline During sessions Just after session 1 month after last session;To compare the effects of combined cue-exposure and administration of HD t-DCS, administration of only HD t-DCS (exposure to neutral cues), only cue-exposure (with sham HD t-DCS), and sham stimulation (with neutral cues) for reduction of the frequency of other drug or alcohol use, duration of use, and abstinenceTimepoint: 1 month after exposure;To compare the frequency of adverse events in participants undergoing HD-tDCS and sham stimulationTimepoint: Just after last session;To evaluate the proportion of eligible participants that provide personalized cue-based images and to study the feasibility of the use of personalized cannabis cues during the cue-exposure based sessionsTimepoint: At the end of the study;To evaluate what proportion of eligible study participants, consent for the study, initiate HD t-DCS sessions, continue at least 3 sessions, and complete all six sessionsTimepoint: At the end of the study;To study the effect of HD- tDCS on cognitive functionsTimepoint: Baseline Just after last session 1 month after last session

Countries

India

Contacts

Public ContactDevika Chauhan

Postgraduate Institute of Medical Education and Research

ghoshabhishek12@gmail.com9815890436

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026