A Teleheath tDCS Approach to Decrease Cannabis Use

Not Applicable

Completed

Conditions: Multiple Sclerosis
Cannabis Use Disorder

Interventions: Other: Transcranial Direct Current Stimulation (tDCS)
Other: Sham - Transcranial Direct Current Stimulation (tDCS)
Other: Mindfulness

Registration Number: NCT05005013

Lead Sponsor: NYU Langone Health

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 52

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active tDCS + Mindfulness	Transcranial Direct Current Stimulation (tDCS)	-
Sham tDCS + Mindfulness	Sham - Transcranial Direct Current Stimulation (tDCS)	-
Active tDCS + Mindfulness	Mindfulness	-
Sham tDCS + Mindfulness	Mindfulness	-

Primary Outcome Measures

Name	Time	Method
Change in Marijuana Craving Questionnaire (MCQ-17) Score	Baseline, Week 6	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.
Change in Frequency of Cannabis Use	Baseline, Week 6	Self-reported in Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis-Use Inventory (DFAQ-CU).
Age of Onset of Cannabis Use	Baseline	Self-reported in Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis-Use Inventory (DFAQ-CU).
Change in Positive and Negative Affect Schedule (PANAS-SF) Score	Baseline, Week 6	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.
Change in Cannabis Withdrawal Scale (CWS) Score	Baseline, Week 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.
Change in Number of Daily Sessions of Cannabis Use	Baseline, Week 6	Self-reported in Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis-Use Inventory (DFAQ-CU).
Change in Kessler Psychological Distress Scale (K10) Score	Baseline, Week 6	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.

Secondary Outcome Measures

Name	Time	Method
Change in Marijuana Craving Questionnaire (MCQ-17) Score	Week 6, Month 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). 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.
Change in Cannabis Withdrawal Scale (CWS) Score	Week 6, Month 3	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.
Change in Kessler Psychological Distress Scale (K10) Score	Week 6, Month 3	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.
Change in Positive and Negative Affect Schedule (PANAS-SF) Score	Week 6, Month 3	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.
Change in Number of Daily Sessions of Cannabis Use	Week 6, Month 3	Self-reported in Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis-Use Inventory (DFAQ-CU).
Change in Frequency of Cannabis Use	Week 6, Month 3	Self-reported in Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis-Use Inventory (DFAQ-CU).