A Teleheath tDCS Approach to Decrease Cannabis Use

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Cannabis Use Disorder
• Intervention / Treatment: Other: Transcranial Direct Current Stimulation (tDCS); Other: Mindfulness; Other: Sham - Transcranial Direct Current Stimulation (tDCS)

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10017
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Ages 21-65 (inclusive)
2. Seeking treatment to reduce or discontinue current cannabis use (smoke/vape/ingest)
3. Current Cannabis Use Disorder per DSM-V (MINI for DSM-V)
4. K10 score 10-35, inclusive (mild to high moderate distress)
5. Definite MS diagnosis, relapsing remitting (RRMS) subtype
6. PDDS score 0-7 (mild to moderate neurological disability, established to be able to complete procedures)
7. All medications stable for ≥ 1 month prior to enrollment and throughout the trial
8. Ability to understand the informed consent process and provide consent to participate in the study
9. Stable and continuous access to internet service, email (WiFi "hotspot" to be provided if needed)
10. Ability to use mobile devices
11. Fluent in English language (due to outcomes validated in English versions only)
12. WRAT-4 score ≥ 85

Exclusion Criteria:

1. MS clinical relapse or use of high dose of steroids in the past month
2. Patients under medical marijuana use prescribed by a clinician
3. Alcohol, tobacco, or substance use disorder other than cannabis
4. Primary neurologic, psychiatric or other medical disorder other than MS (entry MD screening)
5. Currently meets DSM-V criteria for moderate or severe substance use disorder in the past 6 months for any psychoactive substance.
6. 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
7. Current suicidal ideation or deemed to be of potential risk of self-injury
8. History of traumatic brain injury
9. Seizure disorder or recent (<5 years) seizure history
10. Metal implants in the head or neck
11. Enrolled in group or individual therapy for substance use disorder concurrent to intervention
12. Any skin disorder or skin sensitive area near stimulation locations
13. Pregnant or breastfeeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active tDCS + Mindfulness	Other: 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: Mindfulness; Participants will follow an audio track for guided mindfulness during the stimulation.
Sham Comparator: Sham tDCS + Mindfulness	Other: Mindfulness; Participants will follow an audio track for guided mindfulness during the stimulation.; Other: Sham - Transcranial Direct Current Stimulation (tDCS); The tDCS device is programmed to mimic active tDCS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	Baseline, End of Intervention (Week 4)
Change in Number of Weekly Sessions of Cannabis Use	Self-reported measure.	Baseline, End of Intervention (Week 4)
Change in Number of Monthly Sessions of Cannabis Use	Self-reported measure.	Baseline, End of Intervention (Week 4)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	End of Intervention (Week 4), Month 3
Change in Number of Weekly Sessions of Cannabis Use	Self-reported measure.	End of Intervention (Week 4), Month 3
Change in Number of Monthly Sessions of Cannabis Use	Self-reported measure.	End of Intervention (Week 4), Month 3

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Leigh Charvet, PhD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2022
• Primary Completion (Actual): February 14, 2024
• Study Completion (Actual): May 22, 2024

Study Registration Dates

• First Submitted: August 12, 2021
• First Submitted That Met QC Criteria: August 12, 2021
• First Posted (Actual): August 13, 2021

Study Record Updates

• Last Update Posted (Actual): June 24, 2025
• Last Update Submitted That Met QC Criteria: June 19, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Pathologic Processes; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Multiple Sclerosis; Sclerosis; Marijuana Abuse
• Other Study ID Numbers: 21-01028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to leigh.charvet@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No