Status:
RECRUITING
RS-tDCS for Cannabis Use Disorder: The C.A.R.E.S. Initiative
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Cannabis Use Disorder
Eligibility:
All Genders
22-65 years
Phase:
NA
Brief Summary
The purpose of this sham-controlled pilot randomized controlled trial (RCT) is to evaluate the feasibility, safety, and preliminary efficacy of a one-month intervention consisting of 20 home-based act...
Eligibility Criteria
Inclusion
- Aged 22-65 years (inclusive)
- 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)
- Positive for cannabis on the 11-COOH-THC single panel urine test
- Seeking treatment to reduce or discontinue cannabis use (Marijuana Ladder ranged between 5-8 \[inclusive\])
- Kessler Psychological Distress Scale (K10) score \< 35 (minimal to moderate distress)
- Wide Range Achievement Test-5(WRAT-5) score ≥ 85
- Ability to use mobile devices
- Fluent in English or Spanish
Exclusion
- Cannabis is used exclusively as prescribed or directed by their provider
- Meets DSM-V criteria for substance use disorder within the past six months for any psychoactive substance other than cannabis
- Meets DSM-V criteria for alcohol use disorder within the past six months
- 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).
- Primary neurologic or major medical disorder that would interfere with study participation.
- Enrolled in group or individual therapy for substance use disorder that would be concurrent with the study intervention
- History of moderate or severe traumatic brain injury
- Seizure disorder or recent (\<5 years) seizure history
- Presence of metal or active implants in the head/neck
- Any skin disorder or skin sensitive area near stimulation locations
- Pregnant or planning pregnancy during the study period or breastfeeding
Key Trial Info
Start Date :
November 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT07184983
Start Date
November 12 2025
End Date
November 1 2027
Last Update
November 13 2025
Active Locations (1)
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1
NYU Langone Health
New York, New York, United States, 10016