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

NCT07184983 | Recruiting FDA Device

• 2 other identifiers: 25-004891UG3DA063344-01
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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 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).

Conditions

Cannabis Use Disorder

Keywords

Cannabis; CUD; tDCS; Transcranial Direct Current Stimulation; Neuromodulation; Brain Stimulation

Outcome Measures

Primary Outcomes (6)

• The proportion of participants who complete at least 70% (14 out of 20) of intervention sessions

  End of treatment (up to 6 weeks)

• The proportion of participants who discontinue due to adverse effects

  End of treatment (up to 6 weeks)

• The proportion of participants with no serious adverse events

  End of treatment (up to 6 weeks)

• Change in cannabis use frequency, measured by the Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis-Use Inventory (DFAQ-CU)

  The DFAQ-CU is a self-report scale used to assess cannabis use behaviors. It measures frequency, quantity, age of onset, and daily sessions of cannabis use, including different forms like dry product, concentrates, and edibles. The DFAQ-CU also includes visual aids and questions about methods of cannabis administration and tetrahydrocannabinol (THC) levels. Questions 2-3, 6-12 assess frequency.

  Baseline, End of treatment (up to 6 weeks)

• Change in daily cannabis use, measured by the Timeline Followback (TLFB) method assessment

  Daily cannabis use is assessed using the TLFB method, a validated self-report instrument used to collect retrospective estimates of daily cannabis use.

  Baseline, End of treatment (up to 6 weeks)

• Change in cannabis withdrawal symptoms, measured by the Cannabis Withdrawal Scale (CWS)

  The CWS assesses withdrawal symptoms experienced over the last 24 hours and consists of 19 statements. For each statement, its negative impact on normal daily activities is rated on a Likert scale from 0 (not at all) to 10 (extremely). The total score ranges from 0 to 190; higher scores indicate that withdrawal symptoms have a larger negative impact on normal daily activities.

  Baseline, End of treatment (up to 6 weeks)

Secondary Outcomes (8)

• Change in cannabis craving, measured by the Marijuana Craving Questionnaire (MCQ-17)

  Baseline, 1-month follow-up

• Change in psychological distress as measured by the Kessler Psychological Distress Scale (K10)

  Baseline, 1-month follow-up

• Change in anxiety as measured by State-Trait Anxiety Inventory (STAI)

  Baseline, 1-month follow-up

• Change in function as measured by the Marijuana Problem Scale (MPS)

  Baseline, 1-month follow-up

• Change in depression as measured by the Beck Depression Inventory (BDI)

  Baseline, 1-month follow-up

Study Arms (2)

Active tDCS

EXPERIMENTAL

Participants will complete 20 remotely supervised (RS) daily sessions, each 20 minutes, of active dorsolateral prefrontal cortex (DLPFC) tDCS combined with mindfulness meditation.

Device: Active Transcranial Direct Current Stimulation (tDCS); Behavioral: Mindfulness meditation

Sham tDCS

ACTIVE COMPARATOR

Participants will complete 20 RS sham sessions, each 20 minutes, of active DLPFC tDCS combined with mindfulness meditation.

Device: Sham Transcranial Direct Current Stimulation (tDCS); Behavioral: Mindfulness meditation

Interventions

Active Transcranial Direct Current Stimulation (tDCS) DEVICE

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.

Active tDCS

Sham Transcranial Direct Current Stimulation (tDCS) DEVICE

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.

Sham tDCS

Mindfulness meditation BEHAVIORAL

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

Active tDCS; Sham tDCS

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Marijuana Abuse

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Leigh Charvet, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shayna Pehel

CONTACT

929-455-5104; Shayna.Pehel@nyulangone.org

Giuseppina Pilloni

CONTACT

929-455-5317; Giuseppina.Pilloni@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 22, 2025
• Study Start: November 12, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)