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A Teleheath tDCS Approach to Decrease Cannabis Use

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05005013
Recruitment Status : Recruiting
First Posted : August 13, 2021
Last Update Posted : November 4, 2022
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Tracking Information
First Submitted Date  ICMJE August 12, 2021
First Posted Date  ICMJE August 13, 2021
Last Update Posted Date November 4, 2022
Actual Study Start Date  ICMJE August 13, 2022
Estimated Primary Completion Date March 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Teleheath tDCS Approach to Decrease Cannabis Use
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Cannabis Use Disorder
  • Multiple Sclerosis
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 12, 2021)
46
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2024
Estimated Primary Completion Date March 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Matthew Lustberg 929-455-5090 matthew.lustberg@nyulangone.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05005013
Other Study ID Numbers  ICMJE 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  ICMJE
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  ICMJE NYU Langone Health
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Leigh Charvet, PhD NYU Langone Health
PRS Account NYU Langone Health
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP