NCT05005013

A Teleheath tDCS Approach to Decrease Cannabis Use

Completed Phase 2 Results posted Last updated 24 June 2025

What this trial tests

Phase 2 trial testing Transcranial Direct Current Stimulation (tDCS) in Cannabis Use Disorder in 52 participants. Completed in 22 May 2024.

Timeline

13 September 2022

Primary endpoint
14 February 2024

22 May 2024

Quick facts

Lead sponsor	NYU Langone Health
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	52
Start date	13 September 2022
Primary completion	14 February 2024
Estimated completion	22 May 2024
Sites	1 location across United States

Drugs / interventions tested

• Transcranial Direct Current Stimulation (tDCS)
• Sham - Transcranial Direct Current Stimulation (tDCS)
• Mindfulness

Conditions studied

• Cannabis Use Disorder — all drugs for Cannabis Use Disorder →
• Multiple Sclerosis — all drugs for Multiple Sclerosis →

Sponsor

NYU Langone Health — full company profile →

Who can join

Adults 21 to 65, female only, with Cannabis Use Disorder or Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Kessler Psychological Distress Scale (K10) Score Primary · 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.

Group	Value	95% CI
Active tDCS + Mindfulness	6.4	± 6.1
Sham tDCS + Mindfulness	4.5	± 4.2

Change in Positive and Negative Affect Schedule Score - Positive Affect (PANAS-PA) Primary · 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.

Group	Value	95% CI
Active tDCS + Mindfulness	-1.3	± 8.3
Sham tDCS + Mindfulness	1.53	± 8.6

Change in Positive and Negative Affect Schedule Score - Negative Affect (PANAS-NA) Primary · 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.

Group	Value	95% CI
Active tDCS + Mindfulness	-0.7	± 5.2
Sham tDCS + Mindfulness	3	± 4.3

Change in Marijuana Craving Questionnaire (MCQ-17) Score Primary · 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.

Group	Value	95% CI
Active tDCS + Mindfulness	0.27	± 9.5
Sham tDCS + Mindfulness	0.8	± 9.7

Change in Cannabis Withdrawal Scale (CWS) Score Primary · 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.

Group	Value	95% CI
Active tDCS + Mindfulness	27.1	± 29.4
Sham tDCS + Mindfulness	7	± 17.7

Change in Number of Weekly Sessions of Cannabis Use Primary · Baseline, End of Intervention (Week 4)

Self-reported measure.

Group	Value	95% CI
Active tDCS + Mindfulness	1.36	± 2.7
Sham tDCS + Mindfulness	0.54	± 1.9

Change in Number of Monthly Sessions of Cannabis Use Primary · Baseline, End of Intervention (Week 4)

Self-reported measure.

Group	Value	95% CI
Active tDCS + Mindfulness	5.5	± 9.1
Sham tDCS + Mindfulness	3.33	± 6.4

Change in Kessler Psychological Distress Scale (K10) Score Secondary · End of Intervention (Week 4), Month 3

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.

Group	Value	95% CI
Active tDCS + Mindfulness	0.3	± 4.3
Sham tDCS + Mindfulness	1.33	± 4.1

Change in Positive and Negative Affect Schedule Score - Positive Affect (PANAS-PA) Secondary · End of Intervention (Week 4), Month 3

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.

Group	Value	95% CI
Active tDCS + Mindfulness	-1.2	± 6.4
Sham tDCS + Mindfulness	-0.6	± 5.1

Change in Positive and Negative Affect Schedule Score - Negative Affect (PANAS-NA) Secondary · End of Intervention (Week 4), Month 3

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.

Group	Value	95% CI
Active tDCS + Mindfulness	2.6	± 6.4
Sham tDCS + Mindfulness	1	± 4.7

Change in Marijuana Craving Questionnaire (MCQ-17) Score Secondary · End of Intervention (Week 4), Month 3

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.

Group	Value	95% CI
Active tDCS + Mindfulness	2.66	± 9.3
Sham tDCS + Mindfulness	2.53	± 9.6

Change in Cannabis Withdrawal Scale (CWS) Score Secondary · End of Intervention (Week 4), Month 3

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.

Group	Value	95% CI
Active tDCS + Mindfulness	8	± 22
Sham tDCS + Mindfulness	4.5	± 29.4

Adverse events — posted to ClinicalTrials.gov

Time frame: 4 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Active tDCS + Mindfulness

Serious: 0/22 (0%)

Deaths: 0/22

Sham tDCS + Mindfulness

Serious: 0/13 (0%)

Deaths: 0/13

Other adverse events (1 terms — click to expand)

Reaction	System	Active tDCS + Mindfulness	Sham tDCS + Mindfulness
Minor skin irritation	Skin and subcutaneous tissue disorders	—	—

Data from ClinicalTrials.gov NCT05005013 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Stimulated brains and meditative minds: A systematic review on combining low intensity transcranial electrical stimulation and meditation in humans.
   Divarco R, Ramasawmy P, Petzke F, Antal A. · · 2023 · cited 16× · PMID 36817875 · DOI 10.1016/j.ijchp.2023.100369
2. Neuromodulation for Cannabis Use: A Scoping Review.
   Ngoy A, Tang VM, Xiao K, Blumberger DM, et al · · 2024 · cited 3× · PMID 38672008 · DOI 10.3390/brainsci14040356