RS-tDCS for Cannabis Use Disorder: The C.A.R.E.S. Initiative
NCT ID: NCT07184983
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
46 participants
INTERVENTIONAL
2025-11-12
2027-11-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Active tDCS
Participants will complete 20 remotely supervised (RS) daily sessions, each 20 minutes, of active dorsolateral prefrontal cortex (DLPFC) tDCS combined with mindfulness meditation.
Mindfulness meditation
Participants will follow an audio track for guided mindfulness during the stimulation.
Active Transcranial Direct Current Stimulation (tDCS)
tDCS is a noninvasive brain stimulation device that modulates brain activity by delivering low-intensity electrical current (2.0 mA) through scalp sponge electrodes. Device is programmed to ramp up to 2.0 mA (for 30 seconds), provide constant current throughout the session (19 minutes), and then ramp down (for 30 seconds) at the end.
Sham tDCS
Participants will complete 20 RS sham sessions, each 20 minutes, of active DLPFC tDCS combined with mindfulness meditation.
Sham Transcranial Direct Current Stimulation (tDCS)
tDCS is a noninvasive brain stimulation device that modulates brain activity by delivering low-intensity electrical current (2.0 mA) through scalp sponge electrodes. Device is programmed to ramp up to 2.0 mA (for 30 seconds) followed by a ramp down (30 seconds), with no current delivery for 18 minutes, and then ramp up (for 30 seconds) and down (for 30 seconds) at the end.
Mindfulness meditation
Participants will follow an audio track for guided mindfulness during the stimulation.
Interventions
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Sham Transcranial Direct Current Stimulation (tDCS)
tDCS is a noninvasive brain stimulation device that modulates brain activity by delivering low-intensity electrical current (2.0 mA) through scalp sponge electrodes. Device is programmed to ramp up to 2.0 mA (for 30 seconds) followed by a ramp down (30 seconds), with no current delivery for 18 minutes, and then ramp up (for 30 seconds) and down (for 30 seconds) at the end.
Mindfulness meditation
Participants will follow an audio track for guided mindfulness during the stimulation.
Active Transcranial Direct Current Stimulation (tDCS)
tDCS is a noninvasive brain stimulation device that modulates brain activity by delivering low-intensity electrical current (2.0 mA) through scalp sponge electrodes. Device is programmed to ramp up to 2.0 mA (for 30 seconds), provide constant current throughout the session (19 minutes), and then ramp down (for 30 seconds) at the end.
Eligibility Criteria
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Inclusion Criteria
2. Currently meets the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria for CUD, as determined by DSM-V criteria (M.I.N.I)
3. Positive for cannabis on the 11-COOH-THC single panel urine test
4. Seeking treatment to reduce or discontinue cannabis use (Marijuana Ladder ranged between 5-8 \[inclusive\])
5. Kessler Psychological Distress Scale (K10) score \< 35 (minimal to moderate distress)
6. Wide Range Achievement Test-5(WRAT-5) score ≥ 85
7. Ability to use mobile devices
8. Fluent in English or Spanish
Exclusion Criteria
2. Meets DSM-V criteria for substance use disorder within the past six months for any psychoactive substance other than cannabis
3. Meets DSM-V criteria for alcohol use disorder within the past six months
4. Primary psychiatric disorder (major depressive disorder, bipolar disorder, or psychotic disorder) as the principal diagnosis, independent of cannabis use disorder; or current diagnosis of bipolar disorder, psychotic disorder, or any other alcohol/substance use disorder as defined by DSM-5-TR and confirmed via the Mini-International Neuropsychiatric Interview (MINI).
5. Primary neurologic or major medical disorder that would interfere with study participation.
6. Enrolled in group or individual therapy for substance use disorder that would be concurrent with the study intervention
7. History of moderate or severe traumatic brain injury
8. Seizure disorder or recent (\<5 years) seizure history
9. Presence of metal or active implants in the head/neck
10. Any skin disorder or skin sensitive area near stimulation locations
11. Pregnant or planning pregnancy during the study period or breastfeeding
22 Years
65 Years
ALL
No
Sponsors
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NYU Langone Health
OTHER
National Institute on Drug Abuse (NIDA)
NIH
Responsible Party
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Principal Investigators
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Leigh Charvet, PhD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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NYU Langone Health
New York, New York, United States
Countries
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Central Contacts
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Other Identifiers
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25-00489
Identifier Type: -
Identifier Source: org_study_id