A Phase 2 interventional study of Transcranial Direct Current Stimulation (tDCS) and Sham - Transcranial Direct Current Stimulation (tDCS) in Cannabis Use Disorder and Multiple Sclerosis, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to female participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-06-24.
Sponsored by NYU Langone Health · Phase 2, Interventional, and Treatment
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.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 52 is close to the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: Transcranial Direct Current Stimulation (tDCS) · Other: Mindfulness
Other: Sham - Transcranial Direct Current Stimulation (tDCS) · Other: Mindfulness
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.
The tDCS device is programmed to mimic active tDCS.
Participants will follow an audio track for guided mindfulness during the stimulation.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, End of Intervention (Week 4)
Change in Number of Weekly Sessions of Cannabis Use
Self-reported measure.
Time frame: Baseline, End of Intervention (Week 4)
Change in Number of Monthly Sessions of Cannabis Use
Self-reported measure.
Time frame: Baseline, End of Intervention (Week 4)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: End of Intervention (Week 4), Month 3
Change in Number of Weekly Sessions of Cannabis Use
Self-reported measure.
Time frame: End of Intervention (Week 4), Month 3
Change in Number of Monthly Sessions of Cannabis Use
Self-reported measure.
Time frame: End of Intervention (Week 4), Month 3
| Milestone | Active tDCS + Mindfulness | Sham tDCS + Mindfulness |
|---|---|---|
| Started | 31 | 16 |
| Completed | 22 | 13 |
| Not completed | 9 | 3 |
| Withdrew: Withdrawal by subject | 5 | 1 |
| Withdrew: Lost to follow-up | 3 | 1 |
| Withdrew: Ineligibility | 1 | 1 |
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.
| score on a scale | Active tDCS + Mindfulness | Sham tDCS + Mindfulness |
|---|---|---|
| Change in Kessler Psychological Distress Scale (K10) Score | 6.4 ± 6.1 | 4.5 ± 4.2 |
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.
| score on a scale | Active tDCS + Mindfulness | Sham tDCS + Mindfulness |
|---|---|---|
| Change in Positive and Negative Affect Schedule Score - Positive Affect (PANAS-PA) | -1.3 ± 8.3 | 1.53 ± 8.6 |
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.
| score on a scale | Active tDCS + Mindfulness | Sham tDCS + Mindfulness |
|---|---|---|
| Change in Positive and Negative Affect Schedule Score - Negative Affect (PANAS-NA) | -0.7 ± 5.2 | 3 ± 4.3 |
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.
| score on a scale | Active tDCS + Mindfulness | Sham tDCS + Mindfulness |
|---|---|---|
| Change in Marijuana Craving Questionnaire (MCQ-17) Score | 0.27 ± 9.5 | 0.8 ± 9.7 |
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.
| score on a scale | Active tDCS + Mindfulness | Sham tDCS + Mindfulness |
|---|---|---|
| Change in Cannabis Withdrawal Scale (CWS) Score | 27.1 ± 29.4 | 7 ± 17.7 |
Self-reported measure.
| Sessions per week | Active tDCS + Mindfulness | Sham tDCS + Mindfulness |
|---|---|---|
| Change in Number of Weekly Sessions of Cannabis Use | 1.36 ± 2.7 | 0.54 ± 1.9 |
Self-reported measure.
| Sessions per month | Active tDCS + Mindfulness | Sham tDCS + Mindfulness |
|---|---|---|
| Change in Number of Monthly Sessions of Cannabis Use | 5.5 ± 9.1 | 3.33 ± 6.4 |
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.
| score on a scale | Active tDCS + Mindfulness | Sham tDCS + Mindfulness |
|---|---|---|
| Change in Kessler Psychological Distress Scale (K10) Score | 0.3 ± 4.3 | 1.33 ± 4.1 |
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.
| score on a scale | Active tDCS + Mindfulness | Sham tDCS + Mindfulness |
|---|---|---|
| Change in Positive and Negative Affect Schedule Score - Positive Affect (PANAS-PA) | -1.2 ± 6.4 | -0.6 ± 5.1 |
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.
| score on a scale | Active tDCS + Mindfulness | Sham tDCS + Mindfulness |
|---|---|---|
| Change in Positive and Negative Affect Schedule Score - Negative Affect (PANAS-NA) | 2.6 ± 6.4 | 1 ± 4.7 |
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.
| score on a scale | Active tDCS + Mindfulness | Sham tDCS + Mindfulness |
|---|---|---|
| Change in Marijuana Craving Questionnaire (MCQ-17) Score | 2.66 ± 9.3 | 2.53 ± 9.6 |
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.
| score on a scale | Active tDCS + Mindfulness | Sham tDCS + Mindfulness |
|---|---|---|
| Change in Cannabis Withdrawal Scale (CWS) Score | 8 ± 22 | 4.5 ± 29.4 |
Self-reported measure.
| Sessions per week | Active tDCS + Mindfulness | Sham tDCS + Mindfulness |
|---|---|---|
| Change in Number of Weekly Sessions of Cannabis Use | 0.23 ± 2.1 | 0.5 ± 2.5 |
Self-reported measure.
| Sessions per month | Active tDCS + Mindfulness | Sham tDCS + Mindfulness |
|---|---|---|
| Change in Number of Monthly Sessions of Cannabis Use | 1.7 ± 7.4 | 2.6 ± 10.1 |
Collected over 4 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active tDCS + Mindfulness | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
| Sham tDCS + Mindfulness | 0/13 (0%) | 0/13 (0%) | 1/13 (7.7%) |
| Event | Active tDCS + Mindfulness | Sham tDCS + Mindfulness |
|---|---|---|
| Minor skin irritationSkin and subcutaneous tissue disorders | 0/22 | 1/13 |
| Age, Continuous(years) | Active tDCS + Mindfulness | Sham tDCS + Mindfulness | Total |
|---|---|---|---|
| Mean | 39 ± 11 | 46.2 ± 8.8 | 45.7 ± 10.7 |
| Sex: Female, Male(Participants) | Active tDCS + Mindfulness | Sham tDCS + Mindfulness | Total |
|---|---|---|---|
| Female | 22 | 13 | 35 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Active tDCS + Mindfulness | Sham tDCS + Mindfulness | Total |
|---|---|---|---|
| Hispanic or Latino | 6 | 3 | 9 |
| Not Hispanic or Latino | 16 | 9 | 25 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | Active tDCS + Mindfulness | Sham tDCS + Mindfulness | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 11 | 5 | 16 |
| White | 9 | 6 | 15 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 2 | 3 |
| Region of Enrollment(participants) | Active tDCS + Mindfulness | Sham tDCS + Mindfulness | Total |
|---|---|---|---|
| United States | 22 | 13 | 35 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
Supporting information: Study protocol, Sap
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