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TDCS to Reduce Craving in Cocaine Addiction- Phase 2 Study

NCT04994821 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-11-18

No results posted yet for this study

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 a prior Phase-I study, the research team demonstrated feasibility of self-administration of a home-tDCS prototype in 14 patients that applied 15 sessions for each patient at an outpatient center.

Conditions

  • Cocaine Use Disorder
  • Cocaine Dependence

Interventions

DEVICE

transcranial direct current stimulator (tDCS)

Patients will have two electrodes applied (one anode, one cathode) administering active (real) or sham (placebo, not real) tDCS stimulation. Stimulation will last 20 minutes per day, three days per week, for 5 weeks

BEHAVIORAL

Cognitive Reappraisal

Emotion regulation therapy

Sponsors & Collaborators

Principal Investigators

  • Abhishek Datta, PhD · Soterix Medical

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-28
Primary Completion
2022-03-31
Completion
2022-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04994821 on ClinicalTrials.gov