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
2 other identifiers
interventional
120
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2026
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 1, 2026
CompletedFirst Posted
Study publicly available on registry
January 6, 2026
CompletedStudy Start
First participant enrolled
February 25, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2030
March 3, 2026
March 1, 2026
3.9 years
January 1, 2026
March 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Study Arms (4)
Active tDCS with Cognitive Reappraisal (CR)
EXPERIMENTALActive Transcranial Direct Current Stimulation (tDCS) (Soterix Medical mini-CT tDCS stimulator), and Cognitive Reappraisal (CR)
Active tDCS
EXPERIMENTALActive Transcranial Direct Current Stimulation (tDCS), (Soterix Medical mini-CT tDCS stimulator)
Sham tDCS
SHAM COMPARATORSham (Placebo) Transcranial Direct Current Stimulation (tDCS), (Soterix Medical mini-CT tDCS stimulator)
Sham tDCS with Cognitive Reappraisal (CR)
EXPERIMENTALSham (Placebo) Transcranial Direct Current Stimulation (tDCS) (Soterix Medical mini-CT tDCS stimulator), and Cognitive Reappraisal (CR)
Interventions
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
Cognitive reappraisal of drug cues during stimulation sessions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Icahn School of Medicine at Mount Sinailead
- National Institute on Drug Abuse (NIDA)collaborator
- Soterix Medicalcollaborator
Study Sites (1)
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rita Goldstein, PhD
Icahn School of Medicine at Mount Sinai
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 1, 2026
First Posted
January 6, 2026
Study Start
February 25, 2026
Primary Completion (Estimated)
February 1, 2030
Study Completion (Estimated)
February 1, 2030
Last Updated
March 3, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Immediately following publication. No end date.
- 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.
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).