Trial results for a study investigating a telehealth transcranial direct current stimulation (tDCS) approach to decrease cannabis use in individuals with Multiple Sclerosis and Cannabis Use Disorder were posted on ClinicalTrials.gov on 2025-06-24, with 52 participants enrolled.
Background
Multiple Sclerosis (MS) is a chronic, often debilitating disease that affects the brain and spinal cord. Patients with MS can experience a range of symptoms, including pain, fatigue, and neurological dysfunction, which can significantly impact their quality of life. The comorbidity of MS with Cannabis Use Disorder (CUD) and elevated psychological distress presents a complex challenge for patient management. Addressing both cannabis use and distress is crucial for improving overall well-being and potentially mitigating disease burden in this patient population. This study explored a non-invasive intervention to target these intertwined issues.
Trial design
This completed Phase 2 study enrolled 52 participants with Cannabis Use Disorder and Multiple Sclerosis, specifically those with Relapse Remitting Multiple Sclerosis (RRMS), Cannabis Use Disorder (CUD), and elevated distress (K10 score of 10-35). The trial evaluated the effect of Dorsolateral Prefrontal Cortex (DLPFC) Transcranial Direct Current Stimulation (tDCS) combined with mindfulness. Participants were randomized into two groups: an active tDCS + mindfulness group and a sham tDCS + mindfulness control group.
Key results
The trial reported several key measurements related to psychological distress, affect, cannabis craving, withdrawal, and use:
- Change in Kessler Psychological Distress Scale (K10) Score (score on a scale):
- Active tDCS + Mindfulness group showed a mean change of 6.4 (Standard Deviation 6.1).
- Sham tDCS + Mindfulness group showed a mean change of 4.5 (Standard Deviation 4.2).
- Change in Positive and Negative Affect Schedule Score - Positive Affect (PANAS-PA) (score on a scale):
- Active tDCS + Mindfulness group showed a mean change of -1.3 (Standard Deviation 8.3).
- Sham tDCS + Mindfulness group showed a mean change of 1.53 (Standard Deviation 8.6).
- Change in Positive and Negative Affect Schedule Score - Negative Affect (PANAS-NA) (score on a scale):
- Active tDCS + Mindfulness group showed a mean change of -0.7 (Standard Deviation 5.2).
- Sham tDCS + Mindfulness group showed a mean change of 3 (Standard Deviation 4.3).
- Change in Marijuana Craving Questionnaire (MCQ-17) Score (score on a scale):
- Active tDCS + Mindfulness group showed a mean change of 0.27 (Standard Deviation 9.5).
- Sham tDCS + Mindfulness group showed a mean change of 0.8 (Standard Deviation 9.7).
- Change in Cannabis Withdrawal Scale (CWS) Score (score on a scale):
- Active tDCS + Mindfulness group showed a mean change of 27.1 (Standard Deviation 29.4).
- Sham tDCS + Mindfulness group showed a mean change of 7 (Standard Deviation 17.7).
- Change in Number of Weekly Sessions of Cannabis Use (Sessions per week):
- Active tDCS + Mindfulness group showed a mean change of 1.36 (Standard Deviation 2.7).
- Sham tDCS + Mindfulness group showed a mean change of 0.54 (Standard Deviation 1.9).
What this means
The results from this Phase 2 trial suggest that a telehealth tDCS approach combined with mindfulness may offer benefits for individuals with Multiple Sclerosis and Cannabis Use Disorder. The active tDCS + mindfulness group demonstrated a greater mean reduction in Kessler Psychological Distress Scale (K10) scores (6.4 vs. 4.5 for sham) and a substantially larger mean reduction in Cannabis Withdrawal Scale (CWS) scores (27.1 vs. 7 for sham). Additionally, the active group showed a greater mean reduction in weekly cannabis use sessions (1.36 vs. 0.54 for sham). While these findings indicate a potential positive direction of effect for active tDCS, further research with larger cohorts and statistical analyses of between-group differences would be necessary to confirm efficacy and clinical significance.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05005013, titled "A Teleheath tDCS Approach to Decrease Cannabis Use", were posted on 2025-06-24 on clinicaltrials.gov.
