NCT04994821

TDCS to Reduce Craving in Cocaine Addiction- Phase 2 Study

Completed Phase 2 Last updated 18 November 2024

What this trial tests

Phase 2 trial testing transcranial direct current stimulator (tDCS) in Cocaine Use Disorder in 60 participants. Completed in 30 September 2022.

Timeline

28 September 2020

Primary endpoint
31 March 2022

30 September 2022

Quick facts

Lead sponsor	Soterix Medical
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	60
Start date	28 September 2020
Primary completion	31 March 2022
Estimated completion	30 September 2022
Sites	1 location across United States

Drugs / interventions tested

• transcranial direct current stimulator (tDCS)
• Cognitive Reappraisal

Conditions studied

• Cocaine Use Disorder — all drugs for Cocaine Use Disorder →
• Cocaine Dependence — all drugs for Cocaine Dependence →

Sponsor

Soterix Medical — full company profile →

Who can join

Adults 18 to 65, any sex, with Cocaine Use Disorder or Cocaine Dependence. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Neuromodulation Strategies to Reduce Inflammation and Improve Lung Complications in COVID-19 Patients.
   Czura CJ, Bikson M, Charvet L, Chen JDZ, et al · · 2022 · cited 13× · PMID 35911909 · DOI 10.3389/fneur.2022.897124