Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
52 participants
INTERVENTIONAL
2022-09-13
2024-05-22
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Deep Repetitive Transcranial Magnetic Stimulation for Cannabis Use Disorder
NCT06114212
Transcranial Direct Current Stimulation for the Treatment of Deficits After Traumatic Brain Injury
NCT02613936
A Preliminary Investigation of Pre-Frontal Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Cannabis Use Disorder
NCT03144232
Developing Transcranial Neuromodulation Protocols for Learning and Decision-Making
NCT06561828
Excitatory rTMS to the Left Dorsolateral Pre-Frontal Cortex to Reduce Cannabis-Cue Induced Craving
NCT02567344
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Active tDCS + Mindfulness
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.
Mindfulness
Participants will follow an audio track for guided mindfulness during the stimulation.
Sham tDCS + Mindfulness
Sham - Transcranial Direct Current Stimulation (tDCS)
The tDCS device is programmed to mimic active tDCS.
Mindfulness
Participants will follow an audio track for guided mindfulness during the stimulation.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Sham - Transcranial Direct Current Stimulation (tDCS)
The tDCS device is programmed to mimic active tDCS.
Mindfulness
Participants will follow an audio track for guided mindfulness during the stimulation.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
21 Years
65 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institutes of Health (NIH)
NIH
NYU Langone Health
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Leigh Charvet, PhD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
NYU Langone Health
New York, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
21-01028
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.