A Teleheath tDCS Approach to Decrease Cannabis Use

Study Overview
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Brief Summary
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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.

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

Conditions
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Cannabis Use Disorder, Multiple Sclerosis

Intervention / Treatment
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* Other: Transcranial Direct Current Stimulation (tDCS)
* Other: Sham - Transcranial Direct Current Stimulation (tDCS)
* Other: Mindfulness


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active tDCS + Mindfulness<br> | Other: Transcranial Direct Current Stimulation (tDCS)<br>* 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.<br>Other: Mindfulness<br>* Participants will follow an audio track for guided mindfulness during the stimulation.<br>|
| Sham Comparator: Sham tDCS + Mindfulness<br> | Other: Sham - Transcranial Direct Current Stimulation (tDCS)<br>* The tDCS device is programmed to mimic active tDCS.<br>Other: Mindfulness<br>* Participants will follow an audio track for guided mindfulness during the stimulation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, Week 6 | 
| Change in Positive and Negative Affect Schedule (PANAS-SF) Score | PANAS-SF consists of 20 affects (e.g., interested, distressed, excited, upset, etc.). The participant indicates the extent he/she has felt the specific affect over the past week on scale of 1 (very slightly or not at all) to 5 (extremely). The total score ranges from 1-100; the higher the score, the more negative affects felt. | Baseline, Week 6 | 
| 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). There is no total range for scoring because each individual question is assessed separately. Questions 1-7 measure compulsivity. Questions 8-11 measure emotionality. Questions 12-15 measure expectations. Questions 16-17 measure purposefulness. | Baseline, Week 6 | 
| 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. | Baseline, Week 6 | 
| Change in Number of Daily Sessions of Cannabis Use | Self-reported in Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis-Use Inventory (DFAQ-CU). | Baseline, Week 6 | 
| Change in Frequency of Cannabis Use | Self-reported in Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis-Use Inventory (DFAQ-CU). | Baseline, Week 6 | 
| Age of Onset of Cannabis Use | Self-reported in Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis-Use Inventory (DFAQ-CU). | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Week 6, Month 3 | 
| Change in Positive and Negative Affect Schedule (PANAS-SF) Score | PANAS-SF consists of 20 affects (e.g., interested, distressed, excited, upset, etc.). The participant indicates the extent he/she has felt the specific affect over the past week on scale of 1 (very slightly or not at all) to 5 (extremely). The total score ranges from 1-100; the higher the score, the more negative affects felt. | Week 6, 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). There is no total range for scoring because each individual question is assessed separately. Questions 1-7 measure compulsivity. Questions 8-11 measure emotionality. Questions 12-15 measure expectations. Questions 16-17 measure purposefulness. | Week 6, 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. | Week 6, Month 3 | 
| Change in Number of Daily Sessions of Cannabis Use | Self-reported in Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis-Use Inventory (DFAQ-CU). | Week 6, Month 3 | 
| Change in Frequency of Cannabis Use | Self-reported in Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis-Use Inventory (DFAQ-CU). | Week 6, Month 3 |