A Teleheath tDCS Approach to Decrease Cannabis Use

• ClinicalTrials.gov Identifier: NCT05005013
• Recruitment Status: Recruiting
• First Posted: August 13, 2021
• Last Update Posted: November 4, 2022
• Sponsor: NYU Langone Health
• Information provided by (Responsible Party): NYU Langone Health

Tracking Information

• First Submitted Date: August 12, 2021
• First Posted Date: August 13, 2021
• Last Update Posted Date: November 4, 2022
• Actual Study Start Date: August 13, 2022
• Estimated Primary Completion Date: March 31, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 12, 2021)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 12, 2021)

• Change in Kessler Psychological Distress Scale (K10) Score [ Time Frame: 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 [ Time Frame: 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 Marijuana Craving Questionnaire (MCQ-17) Score [ Time Frame: 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 [ Time Frame: 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 Number of Daily Sessions of Cannabis Use [ Time Frame: 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 [ Time Frame: Week 6, Month 3 ]
  Self-reported in Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis-Use Inventory (DFAQ-CU).

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Teleheath tDCS Approach to Decrease Cannabis Use
• Official Title: A Teleheath tDCS Approach to Decrease Cannabis Use: Towards Reducing Multiple Sclerosis Disability
• 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 Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment

Condition

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

Study Arms

• Experimental: Active tDCS + Mindfulness
  Interventions:

  • Other: Transcranial Direct Current Stimulation (tDCS)
  • Other: Mindfulness
• Sham Comparator: Sham tDCS + Mindfulness
  Interventions:

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 12, 2021): 46
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 31, 2024
• Estimated Primary Completion Date: March 31, 2024 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Matthew Lustberg; 929-455-5090; matthew.lustberg@nyulangone.org

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05005013
• Other Study ID Numbers: 21-01028
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to leigh.charvet@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

• Current Responsible Party: NYU Langone Health
• Original Responsible Party: Same as current
• Current Study Sponsor: NYU Langone Health
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Leigh Charvet, PhD; NYU Langone Health

• PRS Account: NYU Langone Health
• Verification Date: July 2022