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A Teleheath tDCS Approach to Decrease Cannabis Use

Primary Purpose

Cannabis Use Disorder, Multiple Sclerosis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation (tDCS)
Sham - Transcranial Direct Current Stimulation (tDCS)
Mindfulness
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cannabis Use Disorder

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • NYU Langone HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active tDCS + Mindfulness

Sham tDCS + Mindfulness

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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).
Change in Frequency of Cannabis Use
Self-reported in Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis-Use Inventory (DFAQ-CU).
Age of Onset of Cannabis Use
Self-reported in Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis-Use Inventory (DFAQ-CU).

Secondary Outcome Measures

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.
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.
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.
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.
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).
Change in Frequency of Cannabis Use
Self-reported in Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis-Use Inventory (DFAQ-CU).

Full Information

First Posted
August 12, 2021
Last Updated
February 1, 2023
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT05005013
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 13, 2022 (Actual)
Primary Completion Date
February 29, 2024 (Anticipated)
Study Completion Date
February 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Use Disorder, Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active tDCS + Mindfulness
Arm Type
Experimental
Arm Title
Sham tDCS + Mindfulness
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
Transcranial Direct Current Stimulation (tDCS)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham - Transcranial Direct Current Stimulation (tDCS)
Intervention Description
The tDCS device is programmed to mimic active tDCS.
Intervention Type
Other
Intervention Name(s)
Mindfulness
Intervention Description
Participants will follow an audio track for guided mindfulness during the stimulation.
Primary Outcome Measure Information:
Title
Change in Kessler Psychological Distress Scale (K10) Score
Description
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.
Time Frame
Baseline, Week 6
Title
Change in Positive and Negative Affect Schedule (PANAS-SF) Score
Description
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.
Time Frame
Baseline, Week 6
Title
Change in Marijuana Craving Questionnaire (MCQ-17) Score
Description
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.
Time Frame
Baseline, Week 6
Title
Change in Cannabis Withdrawal Scale (CWS) Score
Description
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.
Time Frame
Baseline, Week 6
Title
Change in Number of Daily Sessions of Cannabis Use
Description
Self-reported in Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis-Use Inventory (DFAQ-CU).
Time Frame
Baseline, Week 6
Title
Change in Frequency of Cannabis Use
Description
Self-reported in Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis-Use Inventory (DFAQ-CU).
Time Frame
Baseline, Week 6
Title
Age of Onset of Cannabis Use
Description
Self-reported in Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis-Use Inventory (DFAQ-CU).
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Change in Kessler Psychological Distress Scale (K10) Score
Description
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.
Time Frame
Week 6, Month 3
Title
Change in Positive and Negative Affect Schedule (PANAS-SF) Score
Description
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.
Time Frame
Week 6, Month 3
Title
Change in Marijuana Craving Questionnaire (MCQ-17) Score
Description
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.
Time Frame
Week 6, Month 3
Title
Change in Cannabis Withdrawal Scale (CWS) Score
Description
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.
Time Frame
Week 6, Month 3
Title
Change in Number of Daily Sessions of Cannabis Use
Description
Self-reported in Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis-Use Inventory (DFAQ-CU).
Time Frame
Week 6, Month 3
Title
Change in Frequency of Cannabis Use
Description
Self-reported in Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis-Use Inventory (DFAQ-CU).
Time Frame
Week 6, Month 3

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew Lustberg
Phone
929-455-5090
Email
matthew.lustberg@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leigh Charvet, PhD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Lustberg
Phone
929-455-5090
Email
matthew.lustberg@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Leigh Charvet, PhD
First Name & Middle Initial & Last Name & Degree
Robert Charlson, MD
First Name & Middle Initial & Last Name & Degree
Lauren Krupp, MD
First Name & Middle Initial & Last Name & Degree
Giuseppina Pilloni, PhD
First Name & Middle Initial & Last Name & Degree
Colleen Hanlon, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing 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.

Learn more about this trial

A Teleheath tDCS Approach to Decrease Cannabis Use

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