Recruiting

RS-tDCS

Sponsor:

NYU Langone Health

Code:

NCT07184983

Conditions

Cannabis Use Disorder

Eligibility Criteria

Sex: All

Age: 22 - 65

Healthy Volunteers: Not accepted

Interventions

Active Transcranial Direct Current Stimulation (tDCS)

Sham Transcranial Direct Current Stimulation (tDCS)

Mindfulness meditation

Study Details

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

Study ID

NCT07184983

Start date

Nov 12, 2025

Status verified date

Apr, 2026

Completion date

Oct 1, 2026

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Aged 22-65 years (inclusive)
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:

1. Cannabis is used exclusively as prescribed or directed by their provider
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

Study Design

Enrollment

46 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: Sham tDCS

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

Interventions

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 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.

Primary outcome measure

  • The proportion of participants who complete at least 70% (14 out of 20) of intervention sessions [ Time Frame: End of treatment (up to 6 weeks) ]
  • The proportion of participants who discontinue due to adverse effects [ Time Frame: End of treatment (up to 6 weeks) ]
  • The proportion of participants with no serious adverse events [ Time Frame: 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) [ Time Frame: Baseline, End of treatment (up to 6 weeks) ]
  • Change in daily cannabis use, measured by the Timeline Followback (TLFB) method assessment [ Time Frame: Baseline, End of treatment (up to 6 weeks) ]
  • Change in cannabis withdrawal symptoms, measured by the Cannabis Withdrawal Scale (CWS) [ Time Frame: Baseline, End of treatment (up to 6 weeks) ]

Central Contacts and Locations

Central contacts

Shayna Pehel

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

Giuseppina Pilloni

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

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Apr 21, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-07. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-04-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.