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A Teleheath tDCS Approach to Decrease Cannabis Use

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	21 Years - 65 Years
Gender	Female

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05005013
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	NYU Langone Health
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Leigh Charvet, PhD
Principal Investigator Affiliation	NYU Langone Health
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Cannabis Use Disorder, Multiple Sclerosis

Arms & Interventions

Arms

Experimental: Active tDCS + Mindfulness

Sham Comparator: Sham tDCS + Mindfulness

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

NYU Langone Health, New York, New York

Status

Recruiting

Address

NYU Langone Health

New York, New York, 10017

Site Contact

Matthew Lustberg

[email protected]

929-455-5090

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