Cannabis Use DisorderNCT07184983
RS-tDCS for Cannabis Use Disorder: The C.A.R.E.S. Initiative
A study testing Active Transcranial Direct Current Stimulation (tDCS) and Mindfulness meditation in people with Cannabis Use Disorder, run by NYU Langone Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Cannabis Use Disorder
- What is being tested?
- Active Transcranial Direct Current Stimulation (tDCS) and Mindfulness meditation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2025to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
Official title: Telehealth-Delivered tDCS for Cannabis Addiction Recovery: The C.A.R.E.S. (Cannabis Addiction Recovery Enhancement Stimulation) Initiative
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
- Being tested
- Active Transcranial Direct Current Stimulation (tDCS), Sham Transcranial Direct Current Stimulation (tDCS), Mindfulness meditation
- Keywords
- Cannabis, CUD, tDCS, Transcranial Direct Current Stimulation, Neuromodulation, Brain Stimulation
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
Mindfulness meditationBehavioural
Participants will follow an audio track for guided mindfulness during the stimulation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham Transcranial Direct Current Stimulation (tDCS); Behavioral: Mindfulness meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of participants who complete at least 70% (14 out of 20) of intervention sessions
Measured: End of treatment (up to 6 weeks)
The proportion of participants who discontinue due to adverse effects
Measured: End of treatment (up to 6 weeks)
The proportion of participants with no serious adverse events
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, End of treatment (up to 6 weeks)
Secondary outcomes (8)
Change in cannabis craving, measured by the Marijuana Craving Questionnaire (MCQ-17)
Measured: Baseline, 1-month follow-up
Change in psychological distress as measured by the Kessler Psychological Distress Scale (K10)
K10 is a 10-item questionnaire intended to yield a global measure of distress based on questions about anxiety and depressive symptoms that a person has experienced in the most recent 4 week period. Each question is given a score between 1 (none of the time) to 5 (all of the time). The total score ranges from 10 to 50. People with scores < 20 are likely to be well, 20-24 are likely to have a mild mental disorder, 25-29 are likely to have moderate mental disorder, and > 30 are likely to have a severe mental disorder.
Measured: Baseline, 1-month follow-up
Change in anxiety as measured by State-Trait Anxiety Inventory (STAI)
The STAI is a psychological tool used to measure both state anxiety (temporary feelings of nervousness) and trait anxiety (a general tendency to be anxious). It's a 40-item self-report questionnaire, 20 items allocated to each of the S-Anxiety and T-Anxiety subscales, that uses a 4-point Likert scale. Item scores are added to obtain subtest total scores. Scoring should be reversed for anxiety-absent items (19 items of the total 40). Range of scores for each subtest is 20-80, the higher score indicating greater anxiety.
Measured: Baseline, 1-month follow-up
Change in function as measured by the Marijuana Problem Scale (MPS)
The MPS (form AS5) is a self-report assessment that helps the patient identify areas their life affected by marijuana use. It contains 19 items that represent potential negative effects of marijuana on social relationships, self-esteem, motivation and productivity, work and finances, physical health, memory impairment, and legal problems. Items are rated either 0 (Not a problem), 1 (A minor problem), or 2 (A serious problem). Higher scores generally indicate more serious problems with marijuana.
Measured: Baseline, 1-month follow-up
Change in depression as measured by the Beck Depression Inventory (BDI)
BDI is a 21-item self-report scale designed to measure the severity of depressive symptoms. Each item is scored 0-3. The total score range is 0-63; the higher the score, the more severe the depression. A score > 40 indicates extreme depression.
Measured: Baseline, 1-month follow-up
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 THC levels. Questions 2-3, 6-12 assess frequency.
Measured: Baseline, 1-month follow-up
Change in daily cannabis use, measured by the Timeline Followback Method Assessment (TLFB)
Daily cannabis use is assessed using the TLFB method, a validated self-report instrument used to collect retrospective estimates of daily cannabis use.
Measured: Baseline, 1-month follow-up
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.
Measured: Baseline, 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start12 Nov 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis Use DisorderStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Leigh Charvet, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07184983
- Sponsor's protocol ID
- 25-00489
- Other IDs
- 1UG3DA063344-01
- Status last verified
- Apr 2026
- First submitted
- 15 Sep 2025
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to the small sample size and risk of re-identification.
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth-Delivered tDCS for Cannabis Addiction Recovery: The C.A.R.E.S. (Cannabis Addiction Recovery Enhancement Stimulation) Initiative
- ClinicalTrials.gov ID
- NCT07184983
- Acronym / sponsor ID
- 25-00489
- Conditions
- Cannabis Use Disorder
- Keywords
- Cannabis, CUD, tDCS, Transcranial Direct Current Stimulation, Neuromodulation, Brain Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 12 Nov 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 22 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Experimental | Device: Active Transcranial Direct Current Stimulation (tDCS), Behavioral: Mindfulness meditationParticipants will complete 20 remotely supervised (RS) daily sessions, each 20 minutes, of active dorsolateral prefrontal cortex (DLPFC) tDCS combined with mindfulness meditation. |
| Sham tDCS | Active comparator | Device: Sham Transcranial Direct Current Stimulation (tDCS), Behavioral: Mindfulness meditationParticipants will complete 20 RS sham sessions, each 20 minutes, of active DLPFC tDCS combined with mindfulness meditation. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Active tDCS |
| 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. | Device | Sham tDCS |
| Mindfulness meditationParticipants will follow an audio track for guided mindfulness during the stimulation. | Behavioural | Active tDCS, Sham tDCS |
Primary outcome
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)
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.
Change in daily cannabis use, measured by the Timeline Followback (TLFB) method assessment
Time frame: Baseline, End of treatment (up to 6 weeks)
Daily cannabis use is assessed using the TLFB method, a validated self-report instrument used to collect retrospective estimates of daily cannabis use.
Change in cannabis withdrawal symptoms, measured by the Cannabis Withdrawal Scale (CWS)
Time frame: Baseline, End of treatment (up to 6 weeks)
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.
8 secondary outcomes
Change in cannabis craving, measured by the Marijuana Craving Questionnaire (MCQ-17)
Time frame: Baseline, 1-month follow-up
Change in psychological distress as measured by the Kessler Psychological Distress Scale (K10)
Time frame: Baseline, 1-month follow-up
Change in anxiety as measured by State-Trait Anxiety Inventory (STAI)
Time frame: Baseline, 1-month follow-up
Change in function as measured by the Marijuana Problem Scale (MPS)
Time frame: Baseline, 1-month follow-up
Change in depression as measured by the Beck Depression Inventory (BDI)
Time frame: Baseline, 1-month follow-up
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, 1-month follow-up
Change in daily cannabis use, measured by the Timeline Followback Method Assessment (TLFB)
Time frame: Baseline, 1-month follow-up
Change in cannabis withdrawal symptoms, measured by the Cannabis Withdrawal Scale (CWS)
Time frame: Baseline, 1-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to the small sample size and risk of re-identification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Leigh Charvet, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Transcranial Direct Current Stimulation (tDCS) and Mindfulness meditation in people with Cannabis Use Disorder, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shayna Pehel (929-455-5104, Shayna.Pehel@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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 study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.