[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07184983":3,"trial-entities:NCT07184983":125,"trial-summary:NCT07184983":128},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":51,"secondary_outcomes":69,"sex":91,"minimum_age":92,"maximum_age":93,"healthy_volunteers":15,"eligibility_criteria":94,"std_ages":98,"locations":101,"central_contacts":109,"overall_officials":119,"references":123,"see_also_links":124},"NCT07184983","25-00489","RS-tDCS for Cannabis Use Disorder: The C.A.R.E.S. Initiative","Telehealth-Delivered tDCS for Cannabis Addiction Recovery: The C.A.R.E.S. (Cannabis Addiction Recovery Enhancement Stimulation) Initiative","RECRUITING","2026-10-01","2026-04","2026-04-21","2025-11-12","NYU Langone Health","OTHER",false,"The purpose of this sham-controlled pilot randomized controlled trial (RCT) is to evaluate the feasibility, safety, and preliminary efficacy of a one-month intervention consisting of 20 home-based active or sham RS-tDCS sessions paired with audio track guided mindfulness meditation practice in otherwise healthy adults seeking to reduce cannabis use in the context of cannabis use disorder (CUD).",null,[19],"Cannabis Use Disorder",[21,22,23,24,25,26],"Cannabis","CUD","tDCS","Transcranial Direct Current Stimulation","Neuromodulation","Brain Stimulation","INTERVENTIONAL","TREATMENT",[30],"NA",{"count":32,"type":33},46,"ESTIMATED",[35,41,46],{"type":36,"name":37,"description":38,"armGroupLabels":39},"DEVICE","Active Transcranial Direct Current Stimulation (tDCS)","tDCS is a noninvasive brain stimulation device that modulates brain activity by delivering low-intensity electrical current (2.0 mA) through scalp sponge electrodes. Device is programmed to ramp up to 2.0 mA (for 30 seconds), provide constant current throughout the session (19 minutes), and then ramp down (for 30 seconds) at the end.",[40],"Active tDCS",{"type":36,"name":42,"description":43,"armGroupLabels":44},"Sham Transcranial Direct Current Stimulation (tDCS)","tDCS is a noninvasive brain stimulation device that modulates brain activity by delivering low-intensity electrical current (2.0 mA) through scalp sponge electrodes. Device is programmed to ramp up to 2.0 mA (for 30 seconds) followed by a ramp down (30 seconds), with no current delivery for 18 minutes, and then ramp up (for 30 seconds) and down (for 30 seconds) at the end.",[45],"Sham tDCS",{"type":47,"name":48,"description":49,"armGroupLabels":50},"BEHAVIORAL","Mindfulness meditation","Participants will follow an audio track for guided mindfulness during the stimulation.",[40,45],[52,55,57,59,63,66],{"measure":53,"timeFrame":54},"The proportion of participants who complete at least 70% (14 out of 20) of intervention sessions","End of treatment (up to 6 weeks)",{"measure":56,"timeFrame":54},"The proportion of participants who discontinue due to adverse effects",{"measure":58,"timeFrame":54},"The proportion of participants with no serious adverse events",{"measure":60,"description":61,"timeFrame":62},"Change in cannabis use frequency, measured by the Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis-Use Inventory (DFAQ-CU)","The DFAQ-CU is a self-report scale used to assess cannabis use behaviors. It measures frequency, quantity, age of onset, and daily sessions of cannabis use, including different forms like dry product, concentrates, and edibles. The DFAQ-CU also includes visual aids and questions about methods of cannabis administration and tetrahydrocannabinol (THC) levels. Questions 2-3, 6-12 assess frequency.","Baseline, End of treatment (up to 6 weeks)",{"measure":64,"description":65,"timeFrame":62},"Change in daily cannabis use, measured by the Timeline Followback (TLFB) method assessment","Daily cannabis use is assessed using the TLFB method, a validated self-report instrument used to collect retrospective estimates of daily cannabis use.",{"measure":67,"description":68,"timeFrame":62},"Change in cannabis withdrawal symptoms, measured by the Cannabis Withdrawal Scale (CWS)","The CWS assesses withdrawal 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 withdrawal symptoms have a larger negative impact on normal daily activities.",[70,73,76,79,82,85,87,89],{"measure":71,"timeFrame":72},"Change in cannabis craving, measured by the Marijuana Craving Questionnaire (MCQ-17)","Baseline, 1-month follow-up",{"measure":74,"description":75,"timeFrame":72},"Change in psychological distress as measured by the Kessler Psychological Distress Scale (K10)","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 \\\u003C 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.",{"measure":77,"description":78,"timeFrame":72},"Change in anxiety as measured by State-Trait Anxiety Inventory (STAI)","The STAI is a psychological tool used to measure both state anxiety (temporary feelings of nervousness) and trait anxiety (a general tendency to be anxious). It's a 40-item self-report questionnaire, 20 items allocated to each of the S-Anxiety and T-Anxiety subscales, that uses a 4-point Likert scale. Item scores are added to obtain subtest total scores. Scoring should be reversed for anxiety-absent items (19 items of the total 40). Range of scores for each subtest is 20-80, the higher score indicating greater anxiety.",{"measure":80,"description":81,"timeFrame":72},"Change in function as measured by the Marijuana Problem Scale (MPS)","The MPS (form AS5) is a self-report assessment that helps the patient identify areas their life affected by marijuana use. It contains 19 items that represent potential negative effects of marijuana on social relationships, self-esteem, motivation and productivity, work and finances, physical health, memory impairment, and legal problems. Items are rated either 0 (Not a problem), 1 (A minor problem), or 2 (A serious problem). Higher scores generally indicate more serious problems with marijuana.",{"measure":83,"description":84,"timeFrame":72},"Change in depression as measured by the Beck Depression Inventory (BDI)","BDI is a 21-item self-report scale designed to measure the severity of depressive symptoms. Each item is scored 0-3. The total score range is 0-63; the higher the score, the more severe the depression. A score \\> 40 indicates extreme depression.",{"measure":60,"description":86,"timeFrame":72},"The DFAQ-CU is a self-report scale used to assess cannabis use behaviors. It measures frequency, quantity, age of onset, and daily sessions of cannabis use, including different forms like dry product, concentrates, and edibles. The DFAQ-CU also includes visual aids and questions about methods of cannabis administration and THC levels. Questions 2-3, 6-12 assess frequency.",{"measure":88,"description":65,"timeFrame":72},"Change in daily cannabis use, measured by the Timeline Followback Method Assessment (TLFB)",{"measure":67,"description":90,"timeFrame":72},"The CWS assesses withdrawal 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 withdrawal symptoms have a larger negative impact on normal daily activities.","ALL","22 Years","65 Years",{"inclusion":95,"exclusion":96,"raw_text":97},[],[],"Inclusion Criteria:\n\n1. Aged 22-65 years (inclusive)\n2. Currently meets the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria for CUD, as determined by DSM-V criteria (M.I.N.I)\n3. Positive for cannabis on the 11-COOH-THC single panel urine test\n4. Seeking treatment to reduce or discontinue cannabis use (Marijuana Ladder ranged between 5-8 \\[inclusive\\])\n5. Kessler Psychological Distress Scale (K10) score \\\u003C 35 (minimal to moderate distress)\n6. Wide Range Achievement Test-5(WRAT-5) score ≥ 85\n7. Ability to use mobile devices\n8. Fluent in English or Spanish\n\nExclusion Criteria:\n\n1. Cannabis is used exclusively as prescribed or directed by their provider\n2. Meets DSM-V criteria for substance use disorder within the past six months for any psychoactive substance other than cannabis\n3. Meets DSM-V criteria for alcohol use disorder within the past six months\n4. Primary psychiatric disorder (major depressive disorder, bipolar disorder, or psychotic disorder) as the principal diagnosis, independent of cannabis use disorder; or current diagnosis of bipolar disorder, psychotic disorder, or any other alcohol\u002Fsubstance use disorder as defined by DSM-5-TR and confirmed via the Mini-International Neuropsychiatric Interview (MINI).\n5. Primary neurologic or major medical disorder that would interfere with study participation.\n6. Enrolled in group or individual therapy for substance use disorder that would be concurrent with the study intervention\n7. History of moderate or severe traumatic brain injury\n8. Seizure disorder or recent (\\\u003C5 years) seizure history\n9. Presence of metal or active implants in the head\u002Fneck\n10. Any skin disorder or skin sensitive area near stimulation locations\n11. Pregnant or planning pregnancy during the study period or breastfeeding",[99,100],"ADULT","OLDER_ADULT",[102],{"facility":13,"status":8,"city":103,"state":103,"zip":104,"country":105,"geoPoint":106},"New York","10016","United States",{"lat":107,"lon":108},40.71427,-74.00597,[110,115],{"name":111,"role":112,"phone":113,"email":114},"Shayna Pehel","CONTACT","929-455-5104","Shayna.Pehel@nyulangone.org",{"name":116,"role":112,"phone":117,"email":118},"Giuseppina Pilloni","929-455-5317","Giuseppina.Pilloni@nyulangone.org",[120],{"name":121,"affiliation":13,"role":122},"Leigh Charvet, PhD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":126,"biomarkers":127},[19],[],{"nct_id":4,"found":129,"summary":130,"prompt_version":140},true,{"design":131,"status":132,"heading":133,"summary":134,"follow_up":135,"word_count":136,"commitments":137,"compensation":138,"drugs_mentioned":139},"This is a pilot randomized controlled trial, meaning participants will be assigned by chance to receive either the active RS-tDCS or a sham (inactive) version. The study plans to enroll 46 participants.","completed","RS-tDCS for Cannabis Use Disorder","This study is looking at a treatment for Cannabis Use Disorder (CUD) called RS-tDCS, which is a noninvasive brain stimulation device that uses a low electrical current. Participants will also practice mindfulness meditation. The study wants to see if this treatment is safe, possible to do, and if it helps people reduce their cannabis use. You might be able to join if you are 22-65 years old, meet the criteria for CUD, test positive for cannabis, and are looking to cut down or stop using cannabis. The study will measure how many people complete the treatment sessions, how many stop due to side effects, and if there are any serious side effects.","The study measures outcomes at the end of treatment, which is up to 6 weeks.",112,"Participants will have 20 home-based RS-tDCS sessions paired with audio-guided mindfulness meditation over one month.","Not stated in the trial record.",[48],"v2"]