Home-based brain stimulation with guided mindfulness for cannabis use disorder
Telehealth-Delivered tDCS for Cannabis Addiction Recovery: The C.A.R.E.S. (Cannabis Addiction Recovery Enhancement Stimulation) Initiative
NA · NYU Langone Health · NCT07184983
This project tests whether daily at-home mild brain stimulation plus guided mindfulness can help adults with cannabis use disorder reduce or stop their cannabis use.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 22 Years to 65 Years |
| Sex | All |
| Sponsor | NYU Langone Health (other) |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT07184983 on ClinicalTrials.gov |
What this trial studies
This is a sham-controlled, pilot randomized trial testing a one-month program of 20 home-based repeated-session transcranial direct current stimulation (RS-tDCS) paired with audio-guided mindfulness meditation. Eligible adults (ages 22–65) who meet DSM-5 criteria for cannabis use disorder and want to reduce use will be randomized to active or sham stimulation while completing guided mindfulness tracks. The trial focuses on feasibility, safety, and preliminary signals of reduced use or craving, with urine testing and clinical measures used for outcomes. Procedures include on-site screening and device training at NYU Langone followed by remote supervised sessions at home.
Who should consider this trial
Good fit: Adults 22–65 who meet DSM‑5 criteria for cannabis use disorder, test positive for cannabis, want to reduce or stop use, have minimal-to-moderate psychological distress, can use a mobile device, and speak English or Spanish.
Not a fit: People who use cannabis only as prescribed, have recent other substance use disorders or significant psychiatric disorders, or cannot operate mobile devices or attend required on-site visits are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this could offer an accessible, non-drug at-home option to help reduce cravings and cannabis use.
How similar studies have performed: Prior tDCS research for substance use disorders has shown mixed early results, and combining remote tDCS with guided mindfulness is a relatively new approach that remains largely unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New York, New York
- NYU Langone Health — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Leigh Charvet, PhD — NYU Langone Health
- Study coordinator: Shayna Pehel
- Email: Shayna.Pehel@nyulangone.org
- Phone: 929-455-5104
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cannabis Use Disorder, Cannabis, CUD, tDCS, Transcranial Direct Current Stimulation, Neuromodulation, Brain Stimulation