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Behavioural Intervention

Active tDCS for Cocaine Dependence

N/A
Waitlist Available
Led By Abhishek Datta, PhD
Research Sponsored by Soterix Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (pre-tdcs), post-tdcs sessions (approx. week 6), follow-up (every three months for up to 1 year)
Awards & highlights

Summary

Transcranial direct current stimulation (tDCS) is a form of non-invasive brain stimulation in which low level electrical currents are applied to the scalp in order to alter brain function. In the present study, tDCS will be administered with the goal of assessing the tolerability and feasibility of this approach to 1) reduce an individual's level of drug craving and 2) provide evidence to support the use of this device by the patient for future unsupervised stimulation in a non-clinical setting. Research Questions: Can tDCS be used successfully to train cocaine addicted individuals for self-administration purposes? Can active tDCS be used to decrease drug craving in individuals with cocaine use disorders? Does active tDCS outperform sham tDCS in reducing drug craving?

Eligible Conditions
  • Cocaine Use Disorder
  • Cocaine Dependence

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (pre-tdcs), post-tdcs sessions (approx. week 6), follow-up (every three months for up to 1 year)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (pre-tdcs), post-tdcs sessions (approx. week 6), follow-up (every three months for up to 1 year) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Cocaine Craving from Baseline (Obsessive-Compulsive Cocaine Scale score)
Secondary outcome measures
Change in Anxiety symptoms from Baseline (HAM-A score)
Change in Depression symptoms from Baseline (Ham-D score)
Change in Quality of Life from Baseline (WHOQOL-BREF score)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active tDCSExperimental Treatment1 Intervention
Active Transcranial Direct Current Stimulation (tDCS), Soterix Medical mini-CT tDCS stimulator
Group II: Sham tDCSPlacebo Group1 Intervention
Sham (Placebo) Transcranial Direct Current Stimulation (tDCS), Soterix Medical mini-CT tDCS stimulator
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Soterix Medical mini-CT tDCS stimulator
2021
Completed Phase 1
~50

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiOTHER
871 Previous Clinical Trials
527,247 Total Patients Enrolled
Soterix MedicalLead Sponsor
10 Previous Clinical Trials
367 Total Patients Enrolled
Abhishek Datta, PhDPrincipal InvestigatorSoterix Medical
2 Previous Clinical Trials
110 Total Patients Enrolled
~4 spots leftby Jul 2025