Cannabis Use DisorderPhase 2NCT05005013
A Teleheath tDCS Approach to Decrease Cannabis Use
A Phase 2 study testing Transcranial Direct Current Stimulation (tDCS) and Mindfulness in people with Cannabis Use Disorder and Multiple Sclerosis, run by NYU Langone Health at 1 site in United States.
Trial summary
The study aims to evaluate the effect of Dorsolateral Prefrontal Cortex (DLPFC) Transcranial Direct Current Stimulation (tDCS) in decreasing distress and cannabis use. 46 participants with Relapse Remitting Multiple Sclerosis (RRMS), Cannabis Use Disorder (CUD) and elevated distress (K10 score of 10-35) will be… Read more about this study
- Who is it for?
- Ages 21 to 65 years, women only
- Conditions the study is for
- Cannabis Use Disorder, Multiple Sclerosis
- What is being tested?
- Transcranial Direct Current Stimulation (tDCS) and Mindfulness
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2022to 22 May 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 21-65 (inclusive)
- Seeking treatment to reduce or discontinue current cannabis use (smoke/vape/ingest)
- Current Cannabis Use Disorder per DSM-V (MINI for DSM-V)
- K10 score 10-35, inclusive (mild to high moderate distress)
- Definite MS diagnosis, relapsing remitting (RRMS) subtype
- PDDS score 0-7 (mild to moderate neurological disability, established to be able to complete procedures)
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- All medications stable for ≥ 1 month prior to enrollment and throughout the trial
- Ability to understand the informed consent process and provide consent to participate in the study
- Stable and continuous access to internet service, email (WiFi "hotspot" to be provided if needed)
- Ability to use mobile devices
- Fluent in English language (due to outcomes validated in English versions only)
- WRAT-4 score ≥ 85
Who cannot join
- MS clinical relapse or use of high dose of steroids in the past month
- Patients under medical marijuana use prescribed by a clinician
- Alcohol, tobacco, or substance use disorder other than cannabis
- Primary neurologic, psychiatric or other medical disorder other than MS (entry MD screening)
- Currently meets DSM-V criteria for moderate or severe substance use disorder in the past 6 months for any psychoactive substance.
- Meets DSM-V criteria for current panic disorder, obsessive-compulsive disorder, post-traumatic stress syndrome, bipolar affective disorder, schizophrenia, dissociate disorders, and any other psychotic disorder or organic mental disorder
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- Current suicidal ideation or deemed to be of potential risk of self-injury
- History of traumatic brain injury
- Seizure disorder or recent (<5 years) seizure history
- Metal implants in the head or neck
- Enrolled in group or individual therapy for substance use disorder concurrent to intervention
- Any skin disorder or skin sensitive area near stimulation locations
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Teleheath tDCS Approach to Decrease Cannabis Use: Towards Reducing Multiple Sclerosis Disability
The study aims to evaluate the effect of Dorsolateral Prefrontal Cortex (DLPFC) Transcranial Direct Current Stimulation (tDCS) in decreasing distress and cannabis use. 46 participants with Relapse Remitting Multiple Sclerosis (RRMS), Cannabis Use Disorder (CUD) and elevated distress (K10 score of 10-35) will be recruited.
- Conditions
- Cannabis Use Disorder, Multiple Sclerosis
- Being tested
- Transcranial Direct Current Stimulation (tDCS), Sham - Transcranial Direct Current Stimulation (tDCS), Mindfulness
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current Stimulation (tDCS)Other
tDCS is noninvasive brain stimulation device that modulates brain activity by delivering a low-intensity electrical current (2.0 mA) through sponge electrodes placed on the scalp.
Sham - Transcranial Direct Current Stimulation (tDCS)Other
The tDCS device is programmed to mimic active tDCS.
MindfulnessOther
Participants will follow an audio track for guided mindfulness during the stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS + Mindfulness | Experimental | Not described Receives: Other: Transcranial Direct Current Stimulation (tDCS); Other: Mindfulness |
| Sham tDCS + Mindfulness | Sham comparator | Not described Receives: Other: Sham - Transcranial Direct Current Stimulation (tDCS); Other: Mindfulness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Kessler Psychological Distress Scale (K10) Score
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, End of Intervention (Week 4)
Change in Positive and Negative Affect Schedule Score - Positive Affect (PANAS-PA)
The PA subscale includes 10 items describing positive mood states (e.g., "enthusiastic," "interested," "proud"), each rated on a Likert scale from 1 ("very slightly or not at all") to 5 ("extremely"). The total score ranges from 5-50; higher scores indicate greater levels of positive affect, reflecting an individual's engagement, energy, and pleasurable involvement with the environment.
Measured: Baseline, End of Intervention (Week 4)
Change in Positive and Negative Affect Schedule Score - Negative Affect (PANAS-NA)
The NA subscale consists of 10 items representing negative mood states (e.g., "upset," "nervous," "hostile"), each rated on a 5-point Likert scale from 1 ("very slightly or not at all") to 5 ("extremely"). The total score ranges from 5-50; higher scores reflect greater levels of negative affect, capturing distress and unpleasurable engagement with the environment.
Measured: Baseline, End of Intervention (Week 4)
Change in Marijuana Craving Questionnaire (MCQ-17) Score
MCQ is a standardized measure assessing marijuana craving. Each statement is scored on a 7 point likert scale of 1 (strongly disagree) and 7 (strongly agree).
Questions 1-7 measure compulsivity. Questions 8-11 measure emotionality. Questions 12-15 measure expectations. Questions 16-17 measure purposefulness. The total score is the average response score and ranges from 1-7; higher scored indicate greater levels of marijuana craving.
Measured: Baseline, End of Intervention (Week 4)
Change in Cannabis Withdrawal Scale (CWS) Score
The version of CWS used in the study asks about 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 symptoms are having a larger negative impact on normal daily activities.
Measured: Baseline, End of Intervention (Week 4)
Change in Number of Weekly Sessions of Cannabis Use
Self-reported measure.
Measured: Baseline, End of Intervention (Week 4)
Change in Number of Monthly Sessions of Cannabis Use
Self-reported measure.
Measured: Baseline, End of Intervention (Week 4)
Secondary outcomes (7)
Change in Kessler Psychological Distress Scale (K10) Score
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: End of Intervention (Week 4), Month 3
Change in Positive and Negative Affect Schedule Score - Positive Affect (PANAS-PA)
The PA subscale includes 10 items describing positive mood states (e.g., "enthusiastic," "interested," "proud"), each rated on a Likert scale from 1 ("very slightly or not at all") to 5 ("extremely"). The total score ranges from 5-50; higher scores indicate greater levels of positive affect, reflecting an individual's engagement, energy, and pleasurable involvement with the environment.
Measured: End of Intervention (Week 4), Month 3
Change in Positive and Negative Affect Schedule Score - Negative Affect (PANAS-NA)
The NA subscale consists of 10 items representing negative mood states (e.g., "upset," "nervous," "hostile"), each rated on a 5-point Likert scale from 1 ("very slightly or not at all") to 5 ("extremely"). The total score ranges from 5-50; higher scores reflect greater levels of negative affect, capturing distress and unpleasurable engagement with the environment.
Measured: End of Intervention (Week 4), Month 3
Change in Marijuana Craving Questionnaire (MCQ-17) Score
MCQ is a standardized measure assessing marijuana craving. Each statement is scored on a 7 point likert scale of 1 (strongly disagree) and 7 (strongly agree).
Questions 1-7 measure compulsivity. Questions 8-11 measure emotionality. Questions 12-15 measure expectations. Questions 16-17 measure purposefulness. The total score is the average response score and ranges from 1-7; higher scored indicate greater levels of marijuana craving.
Measured: End of Intervention (Week 4), Month 3
Change in Cannabis Withdrawal Scale (CWS) Score
The version of CWS used in the study asks about 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 symptoms are having a larger negative impact on normal daily activities.
Measured: End of Intervention (Week 4), Month 3
Change in Number of Weekly Sessions of Cannabis Use
Self-reported measure.
Measured: End of Intervention (Week 4), Month 3
Change in Number of Monthly Sessions of Cannabis Use
Self-reported measure.
Measured: End of Intervention (Week 4), Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start13 Sep 2022
- Primary completion14 Feb 2024
- Study completion22 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Leigh Charvet, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05005013
- Sponsor's protocol ID
- 21-01028
- Status last verified
- Jun 2025
- First submitted
- 12 Aug 2021
- Last updated
- 24 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Teleheath tDCS Approach to Decrease Cannabis Use: Towards Reducing Multiple Sclerosis Disability
- ClinicalTrials.gov ID
- NCT05005013
- Acronym / sponsor ID
- 21-01028
- Conditions
- Cannabis Use Disorder, Multiple Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 13 Sep 2022 (actual)
- Primary completion
- 14 Feb 2024 (actual)
- Study completion
- 22 May 2024 (actual)
- First posted
- 13 Aug 2021 (actual)
- Results
- Posted 24 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to evaluate the effect of Dorsolateral Prefrontal Cortex (DLPFC) Transcranial Direct Current Stimulation (tDCS) in decreasing distress and cannabis use. 46 participants with Relapse Remitting Multiple Sclerosis (RRMS), Cannabis Use Disorder (CUD) and elevated distress (K10 score of 10-35) will be recruited.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS + Mindfulness | Experimental | Other: Transcranial Direct Current Stimulation (tDCS), Other: Mindfulness |
| Sham tDCS + Mindfulness | Sham comparator | Other: Sham - Transcranial Direct Current Stimulation (tDCS), Other: Mindfulness |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Ages 21-65 (inclusive)
- Seeking treatment to reduce or discontinue current cannabis use (smoke/vape/ingest)
- Current Cannabis Use Disorder per DSM-V (MINI for DSM-V)
- K10 score 10-35, inclusive (mild to high moderate distress)
- Definite MS diagnosis, relapsing remitting (RRMS) subtype
Key exclusion criteria (13 listed)
- MS clinical relapse or use of high dose of steroids in the past month
- Patients under medical marijuana use prescribed by a clinician
- Alcohol, tobacco, or substance use disorder other than cannabis
- Primary neurologic, psychiatric or other medical disorder other than MS (entry MD screening)
- Currently meets DSM-V criteria for moderate or severe substance use disorder in the past 6 months for any psychoactive substance.
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 |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS)tDCS is noninvasive brain stimulation device that modulates brain activity by delivering a low-intensity electrical current (2.0 mA) through sponge electrodes placed on the scalp. | Other | Active tDCS + Mindfulness |
| Sham - Transcranial Direct Current Stimulation (tDCS)The tDCS device is programmed to mimic active tDCS. | Other | Sham tDCS + Mindfulness |
| MindfulnessParticipants will follow an audio track for guided mindfulness during the stimulation. | Other | Active tDCS + Mindfulness, Sham tDCS + Mindfulness |
Primary outcome
Change in Kessler Psychological Distress Scale (K10) Score
Time frame: Baseline, End of Intervention (Week 4)
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.
Change in Positive and Negative Affect Schedule Score - Positive Affect (PANAS-PA)
Time frame: Baseline, End of Intervention (Week 4)
The PA subscale includes 10 items describing positive mood states (e.g., "enthusiastic," "interested," "proud"), each rated on a Likert scale from 1 ("very slightly or not at all") to 5 ("extremely"). The total score ranges from 5-50; higher scores indicate greater levels of positive affect, reflecting an individual's engagement, energy, and pleasurable involvement with the environment.
Change in Positive and Negative Affect Schedule Score - Negative Affect (PANAS-NA)
Time frame: Baseline, End of Intervention (Week 4)
The NA subscale consists of 10 items representing negative mood states (e.g., "upset," "nervous," "hostile"), each rated on a 5-point Likert scale from 1 ("very slightly or not at all") to 5 ("extremely"). The total score ranges from 5-50; higher scores reflect greater levels of negative affect, capturing distress and unpleasurable engagement with the environment.
Change in Marijuana Craving Questionnaire (MCQ-17) Score
Time frame: Baseline, End of Intervention (Week 4)
MCQ is a standardized measure assessing marijuana craving. Each statement is scored on a 7 point likert scale of 1 (strongly disagree) and 7 (strongly agree). Questions 1-7 measure compulsivity. Questions 8-11 measure emotionality. Questions 12-15 measure expectations. Questions 16-17 measure purposefulness. The total score is the average response score and ranges from 1-7; higher scored indicate greater levels of marijuana craving.
Change in Cannabis Withdrawal Scale (CWS) Score
Time frame: Baseline, End of Intervention (Week 4)
The version of CWS used in the study asks about 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 symptoms are having a larger negative impact on normal daily activities.
Change in Number of Weekly Sessions of Cannabis Use
Time frame: Baseline, End of Intervention (Week 4)
Self-reported measure.
Change in Number of Monthly Sessions of Cannabis Use
Time frame: Baseline, End of Intervention (Week 4)
Self-reported measure.
7 secondary outcomes
Change in Kessler Psychological Distress Scale (K10) Score
Time frame: End of Intervention (Week 4), Month 3
Change in Positive and Negative Affect Schedule Score - Positive Affect (PANAS-PA)
Time frame: End of Intervention (Week 4), Month 3
Change in Positive and Negative Affect Schedule Score - Negative Affect (PANAS-NA)
Time frame: End of Intervention (Week 4), Month 3
Change in Marijuana Craving Questionnaire (MCQ-17) Score
Time frame: End of Intervention (Week 4), Month 3
Change in Cannabis Withdrawal Scale (CWS) Score
Time frame: End of Intervention (Week 4), Month 3
Change in Number of Weekly Sessions of Cannabis Use
Time frame: End of Intervention (Week 4), Month 3
Change in Number of Monthly Sessions of Cannabis Use
Time frame: End of Intervention (Week 4), Month 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
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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. This study is not recruiting at the moment.
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 Phase 2 study testing Transcranial Direct Current Stimulation (tDCS) and Mindfulness in people with Cannabis Use Disorder and Multiple Sclerosis, 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 12 inclusion and 13 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: finished, as of the sponsor's last update on 24 Jun 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Kessler Psychological Distress Scale (K10) Score (time frame: Baseline, End of Intervention (Week 4)). The study lists 7 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 24 Jun 2025.