Mild electrical brain stimulation (tDCS) with cognitive training to reduce cocaine cravings.
Cognitively-enhanced tDCS of the Dorsolateral Prefrontal Cortex to Reduce Craving in Cocaine Addiction
NA · Icahn School of Medicine at Mount Sinai · NCT07318480
This trial will test whether brief sessions of mild electrical brain stimulation (tDCS) combined with cognitive reappraisal training can lower craving in adults receiving inpatient treatment for cocaine use disorder.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai (other) |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT07318480 on ClinicalTrials.gov |
What this trial studies
Adults with cocaine use disorder will be randomized in a double‑blind, factorial design to receive real or sham tDCS targeting the dorsolateral prefrontal cortex combined with either cognitive reappraisal training or a control condition. The trial plans to enroll 120 inpatients and deliver repeated stimulation sessions while tracking craving and drug use outcomes during the intervention and at a one‑month follow‑up. Neuroimaging before and after the intervention will be used to identify neural changes linked to recovery and to build predictors of individual response. The design builds on earlier phase 1–2 work and aims to inform development of scalable, potentially self‑administered interventions for managing craving.
Who should consider this trial
Good fit: Adults age 18–60 with a DSM‑5 diagnosis of stimulant use disorder where crack/cocaine is the drug of choice, who can give informed consent and (for women of childbearing potential) use acceptable birth control, are the intended participants.
Not a fit: People with lifetime psychotic or bipolar I disorders, certain unstable or significant medical/neurological conditions, active infectious diseases commonly excluding participation (e.g., untreated Hepatitis B/C or HIV when exclusionary), or other protocol exclusionary medications/conditions are unlikely to be eligible or to gain benefit from this intervention.
Why it matters
Potential benefit: If successful, this could offer a scalable way to reduce craving and lower relapse risk by giving people a tool they can use in real‑time when craving arises.
How similar studies have performed: Earlier Phase‑1 and Phase‑2 trials of tDCS targeting the dorsolateral prefrontal cortex reported promising reductions in craving, but larger randomized trials are needed to confirm benefit.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
New York, New York
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Rita Goldstein, PhD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Kathryn Rachel Drury Clinical Research Coordinator
- Email: NARC@mssm.edu
- Phone: 646-937-2875
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cocaine Use Disorder, Cocaine Dependence, Substance Use Disorder, Transcranial Direct Current Stimulation, Brain Stimulation, cocaine use disorder, drug craving, neuromodulation