Cocaine Use DisorderNCT07318480
Transcranial Direct Current Stimulation (tDCS) for Treatment of Substance Use Disorder
A study testing Transcranial Direct Current Stimulator (tDCS) and Cognitive Reappraisal Training in people with Cocaine Use Disorder and Cocaine Dependence, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cocaine Use Disorder, Cocaine Dependence, Substance Use Disorder (SUD)
- What is being tested?
- Transcranial Direct Current Stimulator (tDCS) and Cognitive Reappraisal Training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2026to Feb 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Clinical Research Coordinator, 646-937-2875, NARC@mssm.edu
About this study
Official title: 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 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.
Read the 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. Beyond CUD, pharmacological treatments, especially buprenorphine and methadone, are effective, but the persistently high overdose rates from opioid use highlight the urgent need for additional evidence-based interventions for opioid use disorders (OUD) as well. 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=240). 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 drug addiction.
- Conditions
- Cocaine Use Disorder, Cocaine Dependence, Substance Use Disorder (SUD), Opioid Use Disorder, Opioid Dependence
- Being tested
- Transcranial Direct Current Stimulator (tDCS), Cognitive Reappraisal Training
- Keywords
- Transcranial Direct Current Stimulation (tDCS), Brain Stimulation, cocaine use disorder, drug craving, neuromodulation, neuroimaging, opioid use disorder
- Medical subject headings
- Cocaine-Related Disorders, Substance-Related Disorders, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current Stimulator (tDCS)Device
Also called Soterix Medical mini-CT tDCS stimulator
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 TrainingBehavioural
Cognitive reappraisal of drug cues during stimulation sessions
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS with Cognitive Reappraisal (CR) | Experimental | Active Transcranial Direct Current Stimulation (tDCS) (Soterix Medical mini-CT tDCS stimulator), and Cognitive Reappraisal (CR) Receives: Device: Transcranial Direct Current Stimulator (tDCS); Behavioral: Cognitive Reappraisal Training |
| Active tDCS | Experimental | Active Transcranial Direct Current Stimulation (tDCS), (Soterix Medical mini-CT tDCS stimulator) Receives: Device: Transcranial Direct Current Stimulator (tDCS) |
| Sham tDCS | Sham comparator | Sham (Placebo) Transcranial Direct Current Stimulation (tDCS), (Soterix Medical mini-CT tDCS stimulator) Receives: Device: Transcranial Direct Current Stimulator (tDCS) |
| Sham tDCS with Cognitive Reappraisal (CR) | Experimental | Sham (Placebo) Transcranial Direct Current Stimulation (tDCS) (Soterix Medical mini-CT tDCS stimulator), and Cognitive Reappraisal (CR) Receives: Device: Transcranial Direct Current Stimulator (tDCS); Behavioral: Cognitive Reappraisal Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At baseline, immediately after 5 weeks of tDCS, and 1 month after interventions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start25 Feb 2026
- Primary completionFeb 2030 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine Use DisorderStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Soterix Medical
- Responsible party
- Principal investigator, Rita Goldstein, Icahn School of Medicine at Mount Sinai
- Investigators
- Rita Goldstein, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07318480
- Sponsor's protocol ID
- GCO 23-1756
- Other IDs
- R01DA060914, UG3DA063211
- Status last verified
- Oct 2026
- First submitted
- 1 Jan 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).