A Teleheath tDCS Approach to Decrease Cannabis Use

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05005013
• Other study ID #: 21-01028
• Status: Completed
• Phase: N/A
• Start date: September 13, 2022
• Est. completion date: May 22, 2024

Study information

• Verified date: June 2024
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: May 22, 2024
• Est. primary completion date: February 14, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cannabis Use Disorder
• Marijuana Abuse
• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Transcranial Direct Current Stimulation (tDCS)
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.
• Sham - Transcranial Direct Current Stimulation (tDCS)
The tDCS device is programmed to mimic active tDCS.
• Mindfulness
Participants will follow an audio track for guided mindfulness during the stimulation.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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