Transcranial Direct Current Stimulation (tDCS) for Treatment of Cocaine Use Disorder

Cognitively-enhanced tDCS of the Dorsolateral Prefrontal Cortex to Reduce Craving in Cocaine Addiction

The researchers will test whether cognitively enhanced transcranial direct current stimulation (tDCS) of the dorsolateral prefrontal cortex can reduce craving in inpatients with cocaine use disorder. Neuroimaging before and after stimulation will establish the neural correlates of recovery and allow predictions of outcomes, which will be assessed throughout the study and one month after its completion. Results could pave the way towards development of a new self-administered intervention to reduce craving when it is needed the most, enhancing recovery real-time and in the natural environment in people with cocaine addiction as generalizable to other drugs of abuse and other disorders of self-control.

Study Overview

• Status: Recruiting
• Conditions: Cocaine Use Disorder; Cocaine Dependence; Substance Use Disorder (SUD)
• Intervention / Treatment: Device: Transcranial Direct Current Stimulator (tDCS); Behavioral: Cognitive Reappraisal Training

Detailed Description

Over the past decade, the US has been affected by a re-emerging stimulant use public health crisis and alarming increases in crack/cocaine-related overdose deaths. In contrast to other types of addiction, there are no FDA approved treatments for crack/cocaine use disorder (CUD). Developing and testing evidence-based treatment options for this population, and exploring the underlying neural substrates, are therefore urgently needed. Core symptoms of addiction are craving and heightened reactivity to drug cues, attributed to impairments in prefrontal functions. This study builds upon Phase-1 and Phase-2 trials testing whether transcranial direct current stimulation (tDCS) targeting the dorsolateral prefrontal cortex can reduce craving in treatment-seeking inpatients with CUD. Participants will be randomized to receive real or sham tDCS, combined with cognitive reappraisal training of drug cues or a control condition, in a double-blind, factorial design (N=120). Craving and drug use outcomes will be assessed throughout the intervention and at one-month follow-up. Neuroimaging will be used to examine neural correlates of treatment response. Results may inform development of scalable, self-administered interventions to reduce craving and relapse risk in cocaine addiction.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kathryn Rachel Drury Clinical Research Coordinator; Phone Number: 646-937-2875; Email: NARC@mssm.edu
• Study Contact Backup: Name: Maggie Boros Clinical Research Coordinator; Phone Number: 646-937-2875; Email: NARC@mssm.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Icahn School of Medicine at Mount Sinai
      • Contact: Rachel Drury; Phone Number: 646-937-2875; Email: NARC@mssm.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Ability to understand and give informed consent
• Men and women 18-60 years of age.
• For women of childbearing potential, current use of a medically acceptable form of birth control
• DSM-5 diagnosis of stimulant use disorder with crack/cocaine as the drug of choice

Exclusion Criteria:

• Lifetime diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar I disorder, or delusional disorder as confirmed by the MINI or autism spectrum disorder as confirmed by medical history at the screening visit
• Current clinically significant or unstable medical conditions, including metabolic, endocrinological, oncological or autoimmune diseases, infectious diseases common in people with substance use disorders including Hepatitis B and C or HIV/AIDS; use of medications deemed exclusionary by the study team; or any laboratory value outside the reference range that the senior investigator team considers to be of clinical relevance
• Head trauma with loss of consciousness (>30 min)
• History of neurological or developmental disease of central origin including stroke, brain tumor or seizures, encompassing those symptoms associated with periods of drug withdrawal or abstinence
• Metal implants or devices that may be impacted by the electrical stimulation and additional MR contraindications
• Women of childbearing potential must use a medically acceptable birth control method during the study and will be asked to take a pregnancy urine test before exposure to tDCS (or MRI)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active tDCS; Active Transcranial Direct Current Stimulation (tDCS), (Soterix Medical mini-CT tDCS stimulator)	Device: Transcranial Direct Current Stimulator (tDCS); Participants will have two electrodes applied (one anode, one cathode) administering active (real) or sham (placebo, not real) tDCS stimulation of the dorsolateral prefrontal cortex. Stimulation will last 20 minutes per day, three days per week, for 5 weeks; Other Names: Soterix Medical mini-CT tDCS stimulator
Experimental: Active tDCS with Cognitive Reappraisal (CR); Active Transcranial Direct Current Stimulation (tDCS) (Soterix Medical mini-CT tDCS stimulator), and Cognitive Reappraisal (CR)	Device: Transcranial Direct Current Stimulator (tDCS); Participants will have two electrodes applied (one anode, one cathode) administering active (real) or sham (placebo, not real) tDCS stimulation of the dorsolateral prefrontal cortex. Stimulation will last 20 minutes per day, three days per week, for 5 weeks; Other Names: Soterix Medical mini-CT tDCS stimulator; Behavioral: Cognitive Reappraisal Training; Cognitive reappraisal of drug cues during stimulation sessions
Sham Comparator: Sham tDCS; Sham (Placebo) Transcranial Direct Current Stimulation (tDCS), (Soterix Medical mini-CT tDCS stimulator)	Device: Transcranial Direct Current Stimulator (tDCS); Participants will have two electrodes applied (one anode, one cathode) administering active (real) or sham (placebo, not real) tDCS stimulation of the dorsolateral prefrontal cortex. Stimulation will last 20 minutes per day, three days per week, for 5 weeks; Other Names: Soterix Medical mini-CT tDCS stimulator
Experimental: Sham tDCS with Cognitive Reappraisal (CR); Sham (Placebo) Transcranial Direct Current Stimulation (tDCS) (Soterix Medical mini-CT tDCS stimulator), and Cognitive Reappraisal (CR)	Device: Transcranial Direct Current Stimulator (tDCS); Participants will have two electrodes applied (one anode, one cathode) administering active (real) or sham (placebo, not real) tDCS stimulation of the dorsolateral prefrontal cortex. Stimulation will last 20 minutes per day, three days per week, for 5 weeks; Other Names: Soterix Medical mini-CT tDCS stimulator; Behavioral: Cognitive Reappraisal Training; Cognitive reappraisal of drug cues during stimulation sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fMRI blood-oxygenation level dependent (BOLD) signal	Neuroimaging - Measure of fMRI blood-oxygenation level dependent (BOLD) signal in the dorsolateral prefrontal cortex before and immediately after 5 weeks of tDCS.	At baseline and immediately after 5 weeks of tDCS.
Change in Self-Reported Craving Score	Changes in measures of craving cocaine craving on a 0-9 point scale in response to interventions, with high scores indicating higher craving.	At baseline, immediately after 5 weeks of tDCS, and 1 month after interventions.

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: National Institute on Drug Abuse (NIDA); Soterix Medical
• Investigators: Principal Investigator: Rita Goldstein, PhD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2026
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): February 1, 2030

Study Registration Dates

• First Submitted: January 1, 2026
• First Submitted That Met QC Criteria: January 1, 2026
• First Posted (Actual): January 6, 2026

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: neuroimaging; neuromodulation; Brain Stimulation; Transcranial Direct Current Stimulation (tDCS); drug craving; cocaine use disorder
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Cocaine-Related Disorders
• Other Study ID Numbers: GCO 23-1756; R01DA060914 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Immediately following publication. No end date.
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal. Any purpose. Proposals should be directed to NARC@mssm.edu. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No