A Teleheath tDCS Approach to Decrease Cannabis Use

NCT05005013 | Completed Phase 2 Results

• 1 other identifier: 21-01028
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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 recruited.

Conditions

Cannabis Use Disorder; Multiple Sclerosis

Outcome Measures

Primary 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.

  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 Outcomes (7)

• Change in Kessler Psychological Distress Scale (K10) Score

  End of Intervention (Week 4), Month 3

• Change in Positive and Negative Affect Schedule Score - Positive Affect (PANAS-PA)

  End of Intervention (Week 4), Month 3

• Change in Positive and Negative Affect Schedule Score - Negative Affect (PANAS-NA)

  End of Intervention (Week 4), Month 3

• Change in Marijuana Craving Questionnaire (MCQ-17) Score

  End of Intervention (Week 4), Month 3

• Change in Cannabis Withdrawal Scale (CWS) Score

  End of Intervention (Week 4), Month 3

Study Arms (2)

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

Interventions

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.

Active tDCS + Mindfulness

Sham - Transcranial Direct Current Stimulation (tDCS) OTHER

The tDCS device is programmed to mimic active tDCS.

Sham tDCS + Mindfulness

Mindfulness OTHER

Participants will follow an audio track for guided mindfulness during the stimulation.

Active tDCS + Mindfulness; Sham tDCS + Mindfulness

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10017, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Transcranial Direct Current Stimulation; Mindfulness

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy

Results Point of Contact

• Title: Matthew Lustberg
• Organization: NYU Langone Health

matthew.lustberg@nyulangone.org

929-455-5090

Study Officials

• Leigh Charvet, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: August 13, 2021
• Study Start: September 13, 2022
• Primary Completion: February 14, 2024
• Study Completion: May 22, 2024
• Last Updated: June 24, 2025
• Results First Posted: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

US (1)