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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Icahn School of Medicine at Mount Sinai • ClinicalTrials.gov ID: NCT07318480

Registry updated: 2026-10-13
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Description

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 or opioid 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.

Interventions

  • Transcranial Direct Current Stimulator (tDCS) (Device)
    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 Training (Behavioral)
    Cognitive reappraisal of drug cues during stimulation sessions

Eligibility 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 or opioid use disorder 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)

Conditions

Cocaine Use Disorder Cocaine Dependence Substance Use Disorder (SUD) Opioid Use Disorder Opioid Dependence

Locations

  • Icahn School of Medicine at Mount Sinai — New York, New York, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record