Recruiting

tDCS

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT07318480

Conditions

Cocaine Use Disorder

Cocaine Dependence

Substance Use Disorder (SUD)

Opioid Use Disorder

Opioid Dependence

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Transcranial Direct Current Stimulator (tDCS)

Cognitive Reappraisal Training

Study Details

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 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.

Conditions

Cocaine Use Disorder

Cocaine Dependence

Substance Use Disorder (SUD)

Opioid Use Disorder

Opioid Dependence

Study ID

NCT07318480

Start date

Feb 25, 2026

Status verified date

Oct, 2026

Completion date

Feb, 2030

Anticipated

Primary completion date

Feb, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active tDCS with Cognitive Reappraisal (CR)

Active Transcranial Direct Current Stimulation (tDCS) (Soterix Medical mini-CT tDCS stimulator), and Cognitive Reappraisal (CR)

experimental: Active tDCS

Active Transcranial Direct Current Stimulation (tDCS), (Soterix Medical mini-CT tDCS stimulator)

sham comparator: Sham tDCS

Sham (Placebo) Transcranial Direct Current Stimulation (tDCS), (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)

Interventions

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

Cognitive Reappraisal Training

Cognitive reappraisal of drug cues during stimulation sessions

Primary outcome measure

  • fMRI blood-oxygenation level dependent (BOLD) signal [ Time Frame: At baseline and immediately after 5 weeks of tDCS. ]
  • Change in Self-Reported Craving Score [ Time Frame: At baseline, immediately after 5 weeks of tDCS, and 1 month after interventions. ]

Central Contacts and Locations

Central contacts

Jason Amadio, Clinical Research Coordinator

646-937-2875NARC@mssm.edu

Ava Eggener, Clinical Research Coordinator

646-937-2875NARC@mssm.edu

Locations

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Clinical Research Coordinator

646-937-2875NARC@mssm.edu

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Oct 13, 2026

Last verified

Oct, 2026

Keywords

  • Transcranial Direct Current Stimulation (tDCS)
  • Brain Stimulation
  • cocaine use disorder
  • drug craving
  • neuromodulation
  • neuroimaging
  • opioid use disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.