[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03984565":3,"trial-entities:NCT03984565":115,"trial-summary:NCT03984565":118},{"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":19,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":43,"secondary_outcomes":48,"sex":64,"minimum_age":65,"maximum_age":66,"healthy_volunteers":14,"eligibility_criteria":67,"std_ages":83,"locations":86,"central_contacts":106,"overall_officials":109,"references":113,"see_also_links":114},"NCT03984565","2023P001774","PAIN: A Project Assessing the Impact of a Novel Cannabinoid Product","RECRUITING","2026-09","2026-03","2026-03-30","2024-06-27","Staci Gruber, Ph.D.","OTHER",false,"This study is a clinical trial of a high-cannabidiol (CBD) sublingual product compared to placebo for 9 weeks in patients with chronic pain conditions. The study will assess the impact of CBD on chronic pain symptoms, conventional medication use, clinical state, quality of life, cognition, and biomarkers.","Cannabis sativa has been used medicinally to treat a wide range of disorders for thousands of years. Cannabis is comprised of more than 100 cannabinoids, including D9-tetrahydrocannabinol (THC), the major intoxicating constituent, and cannabidiol (CBD), the major non-intoxicating constituent that has a number of potential therapeutic properties. Although a wide range of medical cannabis (MC) and hemp products (containing less than 0.3% THC) are used by consumers for a variety of medical indications, little is known about the direct impact of individual cannabinoids and constituent ratios on the symptoms that cause patients to seek treatment.\n\nChronic pain is one of the most common indications for MC use, and several studies have yielded compelling data suggesting that MC and its constituents may have analgesic and anti-inflammatory properties, suggesting that cannabinoids may have the potential to treat chronic pain. This investigation will involve a placebo-controlled crossover trial of a hemp-derived high-CBD, low-THC sublingual product in patients with chronic pain; patients will be assessed at baseline and over 69weeks of treatment with CBD or placebo on measures of clinical state, including pain and related symptoms, conventional medication use, and cognition, and provide samples for analysis of inflammatory markers.",[18],"Chronic Pain",[20,21,22],"Cannabidiol","Medical Cannabis","Industrial Hemp","INTERVENTIONAL","TREATMENT",[26],"PHASE2",{"count":28,"type":29},25,"ESTIMATED",[31,38],{"type":32,"name":20,"description":33,"armGroupLabels":34,"otherNames":36},"DRUG","High-CBD, low-THC sublingual product formulated in palm oil",[35],"Cannabidiol Treatment Arm",[37],"CBD",{"type":32,"name":39,"description":40,"armGroupLabels":41},"Placebo","Placebo sublingual product formulated in palm oil with supplemental terpenes to match CBD product.",[42],"Placebo Treatment Arm",[44],{"measure":45,"description":46,"timeFrame":47},"Change in pain ratings on a Numerical Rating Scale (NRS)","The NRS is an 11-point scale on which subjects rate their pain by choosing a number between 0 (no pain) and 10 (worst possible pain). Lower scores indicate less pain.","6 weeks",[49,52,55,58,61],{"measure":50,"description":51,"timeFrame":47},"Change in pain ratings on the Brief Pain Inventory (BPI)","The BPI contains 9 questions that assess the severity of pain, how much relief is provided by treatment, and the functional impact of the pain within the last 24 hours. Lower scores are better.",{"measure":53,"description":54,"timeFrame":47},"Change in ratings on the Pain Self-Efficacy Questionnaire (PSEQ)","The PSEQ contains several questions assessing the patients' confidence in carrying out certain activities despite their pain on a 7-point scale ranging from 0 (not at all confident) to 6 (completely confident). Higher scores are better.",{"measure":56,"description":57,"timeFrame":47},"Change in ratings on the Pain Distress Scale (PDS)","The PDS is an 11-point scale one where subjects rate their pain by level of distress the pain causes on a scale of 0 to 10. Lower scores are better.",{"measure":59,"description":60,"timeFrame":47},"Change in ratings on the Pain Disability Index (PDI)","On the PDI, the subject rates how their pain affects 7 different areas of their life on a scale of the level of disability that their pain causes, from \"no disability\" to \"worst disability\". Lower scores are better.",{"measure":62,"description":63,"timeFrame":47},"Change in Conventional Medication Use","Change in conventional medication use, including opioids, will be assessed and analyzed. Changes in dose and frequency of conventional medication use will be quantified.","ALL","21 Years",null,{"inclusion":68,"exclusion":73,"raw_text":82},[69,70,71,72],"Subject has provided informed consent","Subject is 21 or older","Subject is fluent in English","Subject endorses a musculoskeletal chronic pain condition including, but not limited to, chronic pain due to injury, arthritis (including osteoarthritis and rheumatoid arthritis), bursitis, etc.",[74,75,76,77,78,79,80,81],"Non-fluent English speakers","Estimated IQ \\\u003C 75","A history of head injury or loss of consciousness greater than 5 minutes","Currently uses CBD products regularly","Female subjects will be excluded if they have a positive urine pregnancy test, are trying to become pregnant, or are currently breastfeeding","Presence of a serious or unstable medical illness, including liver, kidney, or cardiovascular disease (hyper\u002Fhypotension, cardiac disorders), or neurological disorder (including seizure disorder)","Primary neuropathic pain or cancer-related pain; patients experiencing neuropathic pain secondary to musculoskeletal pain will be allowed to enter the study","Disclosure of a genetic polymorphism affecting CYP2C9 function","Inclusion Criteria:\n\n* Subject has provided informed consent\n* Subject is 21 or older\n* Subject is fluent in English\n* Subject endorses a musculoskeletal chronic pain condition including, but not limited to, chronic pain due to injury, arthritis (including osteoarthritis and rheumatoid arthritis), bursitis, etc.\n\nExclusion Criteria:\n\n* Non-fluent English speakers\n* Estimated IQ \\\u003C 75\n* A history of head injury or loss of consciousness greater than 5 minutes\n* Currently uses CBD products regularly\n* Female subjects will be excluded if they have a positive urine pregnancy test, are trying to become pregnant, or are currently breastfeeding\n* Presence of a serious or unstable medical illness, including liver, kidney, or cardiovascular disease (hyper\u002Fhypotension, cardiac disorders), or neurological disorder (including seizure disorder)\n* Primary neuropathic pain or cancer-related pain; patients experiencing neuropathic pain secondary to musculoskeletal pain will be allowed to enter the study\n* Disclosure of a genetic polymorphism affecting CYP2C9 function",[84,85],"ADULT","OLDER_ADULT",[87],{"facility":88,"status":7,"city":89,"state":90,"zip":91,"country":92,"contacts":93,"geoPoint":103},"McLean Hospital","Belmont","Massachusetts","02478","United States",[94,99],{"name":95,"role":96,"phone":97,"email":98},"Staci Gruber, PhD.","CONTACT","617-855-2762","gruber@mclean.harvard.edu",{"name":100,"role":96,"phone":101,"email":102},"Rosie Smith, M.S.","617-855-3338","cbdstudy@mclean.harvard.edu",{"lat":104,"lon":105},42.39593,-71.17867,[107,108],{"name":12,"role":96,"phone":97,"email":98},{"name":100,"role":96,"phone":101,"email":102},[110],{"name":12,"affiliation":111,"role":112},"Mclean Hospital","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":116,"biomarkers":117},[18],[],{"nct_id":4,"found":119,"summary":120,"prompt_version":130},true,{"design":121,"status":122,"heading":123,"summary":124,"follow_up":125,"word_count":126,"commitments":127,"compensation":128,"drugs_mentioned":129},"This is an interventional study, meaning participants will receive a specific treatment. It will involve comparing Cannabidiol (DRUG) to a placebo product.","completed","Study of Cannabidiol for Chronic Pain","This study is looking at how a high-cannabidiol (CBD), low-tetrahydrocannabinol (THC) product, called Cannabidiol (DRUG), affects chronic pain. Researchers want to see if this product can help reduce pain, change how much other pain medications people use, and improve overall well-being and quality of life. You might be able to join if you are 21 or older, speak English, and have chronic musculoskeletal pain like arthritis. The study will compare Cannabidiol (DRUG) to a placebo (an inactive substance that looks and tastes the same) over 9 weeks. The main goal is to see how much your pain ratings change after 6 weeks of treatment. The current status of this study is unclear, and it plans to enroll 25 participants.","The primary endpoint for measuring pain changes is at 6 weeks.",119,"Participants will be assessed at the beginning of the study and over 9 weeks of treatment. This includes measures of pain, medication use, and thinking abilities, and providing samples for analysis.","Not stated in the trial record.",[20,39],"v2"]