Clinical trial NCT05005013: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cannabis Use Disorder
Multiple Sclerosis
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2021-08-13
Enrollment: 52
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Kessler Psychological Distress Scale (K10) Score
timeFrame: Baseline, Week 6
measure: Change in Positive and Negative Affect Schedule (PANAS-SF) Score
timeFrame: Baseline, Week 6
measure: Change in Marijuana Craving Questionnaire (MCQ-17) Score
timeFrame: Baseline, Week 6
measure: Change in Cannabis Withdrawal Scale (CWS) Score
timeFrame: Baseline, Week 6
measure: Change in Number of Daily Sessions of Cannabis Use
timeFrame: Baseline, Week 6
measure: Change in Frequency of Cannabis Use
timeFrame: Baseline, Week 6
measure: Age of Onset of Cannabis Use
timeFrame: Baseline
Secondary outcomes:
measure: Change in Kessler Psychological Distress Scale (K10) Score
timeFrame: Week 6, Month 3
measure: Change in Positive and Negative Affect Schedule (PANAS-SF) Score
timeFrame: Week 6, Month 3
measure: Change in Marijuana Craving Questionnaire (MCQ-17) Score
timeFrame: Week 6, Month 3
measure: Change in Cannabis Withdrawal Scale (CWS) Score
timeFrame: Week 6, Month 3
measure: Change in Number of Daily Sessions of Cannabis Use
timeFrame: Week 6, Month 3
measure: Change in Frequency of Cannabis Use
timeFrame: Week 6, Month 3
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Leigh Charvet, PhD
role: PRINCIPAL_INVESTIGATOR
References: