RecruitingNot ApplicableNCT07184983

RS-tDCS for Cannabis Use Disorder: The C.A.R.E.S. Initiative

Telehealth-Delivered tDCS for Cannabis Addiction Recovery: The C.A.R.E.S. (Cannabis Addiction Recovery Enhancement Stimulation) Initiative

Sponsor

NYU Langone Health

Enrollment

46 participants

Start Date

Nov 12, 2025

Study Type

INTERVENTIONAL

Conditions

Cannabis Use Disorder

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 active or sham RS-tDCS sessions paired with audio track guided mindfulness meditation practice in otherwise healthy adults seeking to reduce cannabis use in the context of cannabis use disorder (CUD).

Eligibility

Min Age: 22 YearsMax Age: 65 Years

Inclusion Criteria8

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 Criteria11

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

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Interventions

DEVICEActive 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.

DEVICESham 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.

BEHAVIORALMindfulness meditation

Participants will follow an audio track for guided mindfulness during the stimulation.