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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

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.

Condition or disease Intervention/treatment Phase
Cannabis Use Disorder Multiple Sclerosis Other: Transcranial Direct Current Stimulation (tDCS) Other: Sham - Transcranial Direct Current Stimulation (tDCS) Other: Mindfulness Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Teleheath tDCS Approach to Decrease Cannabis Use: Towards Reducing Multiple Sclerosis Disability
Actual Study Start Date : August 13, 2022
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active tDCS + Mindfulness 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: Mindfulness
Participants will follow an audio track for guided mindfulness during the stimulation.

Sham Comparator: Sham tDCS + Mindfulness 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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


  4. 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.

  5. 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).

  6. 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).

  7. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


  4. 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.

  5. 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).

  6. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05005013


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

Locations
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United States, New York
NYU Langone Health Recruiting
New York, New York, United States, 10017
Contact: Matthew Lustberg    929-455-5090    matthew.lustberg@nyulangone.org   
Principal Investigator: Leigh Charvet, PhD         
Sub-Investigator: Robert Charlson, MD         
Sub-Investigator: Lauren Krupp, MD         
Sub-Investigator: Giuseppina Pilloni, PhD         
Sub-Investigator: Colleen Hanlon, PhD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Leigh Charvet, PhD NYU Langone Health
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT05005013    
Other Study ID Numbers: 21-01028
First Posted: August 13, 2021    Key Record Dates
Last Update Posted: November 4, 2022
Last Verified: July 2022
Individual Participant Data (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
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Marijuana Abuse
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders