Phase 2
N=47
A Teleheath tDCS Approach to Decrease Cannabis Use
Cannabis Use Disorder · Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT05005013 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Change in Kessler Psychological Distress Scale (K10) Score — 6.4; 4.5 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Transcranial Direct Current Stimulation (tDCS) (Other); Sham - Transcranial Direct Current Stimulation (tDCS) (Other); Mindfulness (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Female
- Sponsor
- NYU Langone Health
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Kessler Psychological Distress Scale (K10) Score |
0.3; 1.33 | — |
| PRIMARY Change in Positive and Negative Affect Schedule Score - Positive Affect (PANAS-PA) |
-1.2; -0.6 | — |
| PRIMARY Change in Positive and Negative Affect Schedule Score - Negative Affect (PANAS-NA) |
2.6; 1 | — |
| PRIMARY Change in Marijuana Craving Questionnaire (MCQ-17) Score |
2.66; 2.53 | — |
| PRIMARY Change in Cannabis Withdrawal Scale (CWS) Score |
8; 4.5 | — |
| PRIMARY Change in Number of Weekly Sessions of Cannabis Use |
0.23; 0.5 | — |
| PRIMARY Change in Number of Monthly Sessions of Cannabis Use |
1.7; 2.6 | — |
| SECONDARY Change in Kessler Psychological Distress Scale (K10) Score |
0.3; 1.33 | — |
| SECONDARY Change in Positive and Negative Affect Schedule Score - Positive Affect (PANAS-PA) |
-1.2; -0.6 | — |
| SECONDARY Change in Positive and Negative Affect Schedule Score - Negative Affect (PANAS-NA) |
2.6; 1 | — |
| SECONDARY Change in Marijuana Craving Questionnaire (MCQ-17) Score |
2.66; 2.53 | — |
| SECONDARY Change in Cannabis Withdrawal Scale (CWS) Score |
8; 4.5 | — |
| SECONDARY Change in Number of Weekly Sessions of Cannabis Use |
0.23; 0.5 | — |
| SECONDARY Change in Number of Monthly Sessions of Cannabis Use |
1.7; 2.6 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT05005013). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.