A Teleheath tDCS Approach to Decrease Cannabis Use

A Teleheath tDCS Approach to Decrease Cannabis Use: Towards Reducing Multiple Sclerosis Disability

CompletedPhase 2Relapsing MSNCT05005013

What it found

Results posted, not judged

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

  • Transcranial Direct Current Stimulation (tDCS)

Placebo

  • Sham - Transcranial Direct Current Stimulation (tDCS)

Given to everyone in the trial

  • Mindfulness

Results by group

Change in Kessler Psychological Distress Scale (K10) Score

Baseline, End of Intervention (Week 4)

GroupValueIntervalNumber analysed
Active tDCS + Mindfulness6.4 score on a scale6.1 (Standard Deviation)22
Sham tDCS + Mindfulness4.5 score on a scale4.2 (Standard Deviation)13

Active tDCS + Mindfulness

6.4

Sham tDCS + Mindfulness

4.5

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

Baseline, End of Intervention (Week 4)

GroupValueIntervalNumber analysed
Active tDCS + Mindfulness-1.3 score on a scale8.3 (Standard Deviation)22
Sham tDCS + Mindfulness1.53 score on a scale8.6 (Standard Deviation)13

Active tDCS + Mindfulness

-1.3

Sham tDCS + Mindfulness

1.53

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

Baseline, End of Intervention (Week 4)

GroupValueIntervalNumber analysed
Active tDCS + Mindfulness-0.7 score on a scale5.2 (Standard Deviation)22
Sham tDCS + Mindfulness3 score on a scale4.3 (Standard Deviation)13

Active tDCS + Mindfulness

-0.7

Sham tDCS + Mindfulness

3

Change in Marijuana Craving Questionnaire (MCQ-17) Score

Baseline, End of Intervention (Week 4)

GroupValueIntervalNumber analysed
Active tDCS + Mindfulness0.27 score on a scale9.5 (Standard Deviation)22
Sham tDCS + Mindfulness0.8 score on a scale9.7 (Standard Deviation)13

Active tDCS + Mindfulness

0.27

Sham tDCS + Mindfulness

0.8

Change in Cannabis Withdrawal Scale (CWS) Score

Baseline, End of Intervention (Week 4)

GroupValueIntervalNumber analysed
Active tDCS + Mindfulness27.1 score on a scale29.4 (Standard Deviation)22
Sham tDCS + Mindfulness7 score on a scale17.7 (Standard Deviation)13

Active tDCS + Mindfulness

27.1

Sham tDCS + Mindfulness

7

Change in Number of Weekly Sessions of Cannabis Use

Baseline, End of Intervention (Week 4)

GroupValueIntervalNumber analysed
Active tDCS + Mindfulness1.36 Sessions per week2.7 (Standard Deviation)22
Sham tDCS + Mindfulness0.54 Sessions per week1.9 (Standard Deviation)13

Active tDCS + Mindfulness

1.36

Sham tDCS + Mindfulness

0.54

Change in Number of Monthly Sessions of Cannabis Use

Baseline, End of Intervention (Week 4)

GroupValueIntervalNumber analysed
Active tDCS + Mindfulness5.5 Sessions per month9.1 (Standard Deviation)21
Sham tDCS + Mindfulness3.33 Sessions per month6.4 (Standard Deviation)12

Active tDCS + Mindfulness

5.5

Sham tDCS + Mindfulness

3.33

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Active tDCS + Mindfulness220 (0.0%)0
Sham tDCS + Mindfulness130 (0.0%)0

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Change in Kessler Psychological Distress Scale (K10) Score

    Baseline, End of Intervention (Week 4)

    Mood and sleep

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

    Baseline, End of Intervention (Week 4)

    Mood and sleep

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

    Baseline, End of Intervention (Week 4)

    Mood and sleep

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

    Baseline, End of Intervention (Week 4)

  • Change in Cannabis Withdrawal Scale (CWS) Score

    Baseline, End of Intervention (Week 4)

  • Change in Number of Weekly Sessions of Cannabis Use

    Baseline, End of Intervention (Week 4)

  • Change in Number of Monthly Sessions of Cannabis Use

    Baseline, End of Intervention (Week 4)

Other measures (7)

  • Change in Kessler Psychological Distress Scale (K10) Score

    End of Intervention (Week 4), Month 3

    Mood and sleep

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

    End of Intervention (Week 4), Month 3

    Mood and sleep

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

    End of Intervention (Week 4), Month 3

    Mood and sleep

  • 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

  • Change in Number of Weekly Sessions of Cannabis Use

    End of Intervention (Week 4), Month 3

  • Change in Number of Monthly Sessions of Cannabis Use

    End of Intervention (Week 4), Month 3

Who could take part

Relapsing MS · 21 to 65

Show the full criteria

Inclusion criteria

1. Ages 21-65 (inclusive) 2. Seeking treatment to reduce or discontinue current cannabis use (smoke/vape/ingest) 3. Current Cannabis Use Disorder per DSM-V (MINI for DSM-V) 4. K10 score 10-35, inclusive (mild to high moderate distress) 5. Definite MS diagnosis, relapsing remitting (RRMS) subtype 6. PDDS score 0-7 (mild to moderate neurological disability, established to be able to complete procedures) 7. All medications stable for ≥ 1 month prior to enrollment and throughout the trial 8. Ability to understand the informed consent process and provide consent to participate in the study 9. Stable and continuous access to internet service, email (WiFi "hotspot" to be provided if needed) 10. Ability to use mobile devices 11. Fluent in English language (due to outcomes validated in English versions only) 12. WRAT-4 score ≥ 85

Exclusion criteria

1. MS clinical relapse or use of high dose of steroids in the past month 2. Patients under medical marijuana use prescribed by a clinician 3. Alcohol, tobacco, or substance use disorder other than cannabis 4. Primary neurologic, psychiatric or other medical disorder other than MS (entry MD screening) 5. Currently meets DSM-V criteria for moderate or severe substance use disorder in the past 6 months for any psychoactive substance. 6. 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 7. Current suicidal ideation or deemed to be of potential risk of self-injury 8. History of traumatic brain injury 9. Seizure disorder or recent (\<5 years) seizure history 10. Metal implants in the head or neck 11. Enrolled in group or individual therapy for substance use disorder concurrent to intervention 12. Any skin disorder or skin sensitive area near stimulation locations 13. Pregnant or breastfeeding

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Sept 2022

    2. Main results due

      Feb 2024

    3. Finished

      May 2024

    4. Results posted

      Jun 2025

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