[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06758596":3,"trial-entities:NCT06758596":109,"trial-summary:NCT06758596":114},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":40,"secondary_outcomes":62,"sex":63,"minimum_age":64,"maximum_age":65,"healthy_volunteers":66,"eligibility_criteria":67,"std_ages":86,"locations":88,"central_contacts":103,"overall_officials":106,"references":107,"see_also_links":108},"NCT06758596","STUDY2024-0596","Research Investigating Drug Effects-2 (RiDE-2)","NOT_YET_RECRUITING","2031-06","2025-09","2025-09-19","2026-07-15","University of Illinois at Chicago","OTHER",false,"The purpose of this study is to better understand how people's mood, behavior, and brains respond to different recreational drugs. We are also trying to understand why some people may feel differently or their brain may respond differently than other people after taking the same recreational drug.",null,[18,19,20],"Cannabis Use","Substance Use Disorder (SUD)","Healthy",[],"INTERVENTIONAL","BASIC_SCIENCE",[25],"EARLY_PHASE1",{"count":27,"type":28},144,"ESTIMATED",[30,36],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DRUG","Placebo Oral Capsule","A capsule that contains only dextrose filler administered during the first or second laboratory visit.",[35],"Placebo oral capsule",{"type":31,"name":37,"description":38,"armGroupLabels":39},"THC","A capsule that contains 7.5 mg of THC as well as dextrose filler administered during the first or second laboratory visit.",[37],[41,45,49,53,56,59],{"measure":42,"description":43,"timeFrame":44},"Recent Substance Use","Participants will complete the 6-month Timeline Follow-Back (TLFB) and Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis Use Inventory (DFAQ-CU) to assess recent substance use. This measure will capture the frequency of substance use during the past 6 months, with greater values indicating more frequent substance use.","Baseline screening, baseline drug administration, and every 6 months over two years of follow-up",{"measure":46,"description":47,"timeFrame":48},"CUD\u002FSUD Symptoms","Participants will complete the SCID CUD diagnosis and symptom assessment at baseline screening and yearly follow-ups to evaluate the presence and severity of cannabis use disorder (CUD) and other substance use disorder (SUD) symptoms.","Baseline screening and yearly over the two-year follow-up.",{"measure":50,"description":51,"timeFrame":52},"Neural Reward Anticipation - fMRI response to reward anticipation (MID)","Participants will complete the Monetary Incentive Delay (MID) task during fMRI scanning to assess neural activation related to reward anticipation. Greater activation in reward-related brain regions (e.g., striatum, prefrontal cortex) indicates greater neural sensitivity to anticipated rewards and the impact of THC on reward processing.","First and second laboratory visits, around 90 minutes to 2 hours after drug administration.",{"measure":54,"description":55,"timeFrame":52},"Computationally-Derived Behavioral Reward Learning Rate - Learning rate (alpha parameter)","Participants will complete the Bandit task during fMRI scanning. A behavioral measure of learning rate (alpha parameter) will be derived from computational models based on the Rescorla-Wagner (RW) model, with higher learning rates indicating greater learning and adaptation to reward contingencies.",{"measure":57,"description":58,"timeFrame":52},"Computationally-Derived Behavioral Reward Sensitivity - Reward sensitivity (inverse temperature parameter)","Participants will complete the Bandit task during fMRI scanning, and a behavioral measure of reward sensitivity will be derived from the Rescorla-Wagner (RW) model. Greater values indicate higher sensitivity to rewards and a stronger preference for rewarding outcomes.",{"measure":60,"description":61,"timeFrame":52},"Neural Encoding of Reward Prediction Errors - fMRI response to reward prediction errors (Bandit Task)","Participants will complete the Bandit task during fMRI scanning. fMRI analysis will focus on trial-wise neural encoding of prediction errors, with greater activation indicating more salient reward learning signals in response to prediction errors, reflecting how the brain processes unexpected outcomes during reward learning.",[],"ALL","18 Years","21 Years",true,{"inclusion":68,"exclusion":74,"raw_text":85},[69,70,71,72,73],"age 18-21 at eligibility visit","body mass index of 18.5-30","report using cannabis ≥10 times in their life and ≥1 time in the past 3 months, but \\\u003C7 days a week (daily)","medically and neurologically healthy","score of ≥0.25 on the Personality Inventory for DSM-5 (PID-5) Anhedonia subscale",[75,76,77,78,79,80,81,82,83,84],"positive urine drug screen (UDS; except for THC) and\u002For positive saliva THC test","contraindication for fMRI BOLD study (e.g., metal implants)","severe mental illness (e.g., psychosis, mania, lifetime moderate-to-severe SUD (including moderate-to-severe CUD))","heavy nicotine use in the past month (\\>20 cigarettes per week or electronic nicotine delivery system (ENDS) use equivalent","night shift work","females who are currently pregnant confirmed by urine pregnancy test, are planning pregnancy, or are lactating","unwilling\u002Funable to sign informed consent document","current or past allergic or adverse reaction or known sensitivity to cannabinoid-like substances (Dronabinol\u002FMarijuana\u002FCannabis\u002FTHC, cannabinoid oil, sesame oil, gelatin, glycerin, and titanium dioxide)","physical or neurological diagnoses (e.g., cancer, diabetes, seizure disorder, Parkinson's, Multiple Sclerosis, loss of consciousness \\>10 min., etc.) that in the opinion of the Study Physician and Investigators could increase safety risks or influence the findings","currently taking any medication that could interact with a single dose of Δ9-THC","Inclusion Criteria:\n\n* age 18-21 at eligibility visit\n* body mass index of 18.5-30\n* report using cannabis ≥10 times in their life and ≥1 time in the past 3 months, but \\\u003C7 days a week (daily)\n* medically and neurologically healthy\n* score of ≥0.25 on the Personality Inventory for DSM-5 (PID-5) Anhedonia subscale\n\nExclusion Criteria:\n\n* positive urine drug screen (UDS; except for THC) and\u002For positive saliva THC test\n* contraindication for fMRI BOLD study (e.g., metal implants)\n* severe mental illness (e.g., psychosis, mania, lifetime moderate-to-severe SUD (including moderate-to-severe CUD))\n* heavy nicotine use in the past month (\\>20 cigarettes per week or electronic nicotine delivery system (ENDS) use equivalent\n* night shift work\n* females who are currently pregnant confirmed by urine pregnancy test, are planning pregnancy, or are lactating\n* unwilling\u002Funable to sign informed consent document\n* current or past allergic or adverse reaction or known sensitivity to cannabinoid-like substances (Dronabinol\u002FMarijuana\u002FCannabis\u002FTHC, cannabinoid oil, sesame oil, gelatin, glycerin, and titanium dioxide)\n* physical or neurological diagnoses (e.g., cancer, diabetes, seizure disorder, Parkinson's, Multiple Sclerosis, loss of consciousness \\>10 min., etc.) that in the opinion of the Study Physician and Investigators could increase safety risks or influence the findings\n* currently taking any medication that could interact with a single dose of Δ9-THC",[87],"ADULT",[89],{"facility":12,"city":90,"state":91,"zip":92,"country":93,"contacts":94,"geoPoint":100},"Chicago","Illinois","60612","United States",[95],{"name":96,"role":97,"phone":98,"email":99},"Natania Crane, PhD","CONTACT","312-413-4453","ncrane3@uic.edu",{"lat":101,"lon":102},41.85003,-87.65005,[104],{"name":96,"role":97,"phone":105,"email":99},"(312) 413-4453",[],[],[],{"nct_id":4,"conditions":110,"biomarkers":113},[111,112],"Cannabis misuse","Substance use disorder",[],{"nct_id":4,"found":66,"summary":115,"prompt_version":125},{"design":116,"status":117,"heading":118,"summary":119,"follow_up":120,"word_count":121,"commitments":122,"compensation":123,"drugs_mentioned":124},"This is an interventional study with 144 planned participants. It involves receiving either a placebo or THC capsule.","completed","Research on Cannabis Use and Brain Responses (RiDE-2)","This study, called RiDE-2, aims to understand how people's mood, behavior, and brains react to recreational drugs like cannabis. Researchers want to see why some individuals might respond differently to the same drug. You might receive either a placebo (a capsule with no active drug) or a capsule containing 7.5 mg of THC (the main active ingredient in cannabis). The study will track your substance use, symptoms related to cannabis or substance use disorder (SUD), and brain activity using fMRI (a type of brain scan) over two years. They are looking for 144 participants aged 18-21 who have used cannabis at least 10 times in their life but not daily.","Participants will be followed for two years after their initial drug administration.",110,"You would have a baseline screening, drug administration visits, and follow-up appointments every 6 months for two years. You would also have yearly symptom assessments and fMRI brain scans.","Not stated in the trial record.",[37],"v2"]