[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648926":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":34,"locations":44,"responsibleParty":64,"collaborators":68,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":74,"sex":80,"minAge":81,"maxAge":30,"enrollmentInfo":82,"targetDuration":30,"studyType":85,"phases":86,"briefSummary":89,"conditions":90,"keywords":94,"overallStatus":47,"whyStopped":30,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Mclean Hospital","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"CBD study product: 1mL dose","EXPERIMENTAL","Participants in this arm will take 1mL of the CBD study product three times per day",[13],"Drug: Custom-formulated, high-CBD study product",{"label":15,"type":10,"description":16,"interventionNames":17},"CBD study product: 0.5mL dose","Participants in this arm will take 0.5mL of the CBD study product three times per day",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Placebo","PLACEBO_COMPARATOR","Participants in this arm will take the placebo study product three times per day",[23],"Drug: Placebo",[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Custom-formulated, high-CBD study product","2 doses of the high-CBD study product will be used, compared to placebo.",[15,9],null,{"type":26,"name":19,"description":32,"armGroupLabels":33,"otherNames":30},"Placebo study product.",[19],[35,40],{"name":36,"role":37,"phone":38,"phoneExt":30,"email":39},"Staci Gruber, PhD","CONTACT","617-855-2762","gruber@mclean.harvard.edu",{"name":41,"role":37,"phone":42,"phoneExt":30,"email":43},"Rosie Smith, M.S.","617-855-2908","rsmith@mclean.harvard.edu",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"McLean Hospital","RECRUITING","Belmont","Massachusetts","02478","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-71.17867,42.39593,{"lat":57,"lon":56},[60,62],{"name":61,"role":37,"phone":42,"phoneExt":30,"email":43},"Rosemary Smith, M.S.",{"name":36,"role":63,"phone":30,"phoneExt":30,"email":30},"PRINCIPAL_INVESTIGATOR",{"type":65,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"SPONSOR_INVESTIGATOR","Staci Gruber, Ph.D.","Director, MIND and CCNC at McLean Hospital; Associate Professor of Psychiatry, Harvard Medical School",[69],{"name":70,"class":71},"National Center for Complementary and Integrative Health (NCCIH)","NIH","100648926","phase-1-assessing-the-mechanisms-and-impact-of-a-novel-cannabinoid-product-for-gynecologic-pain-100648926",false,"NCT07728695","Assessing the Mechanisms and Impact of a Novel Cannabinoid Product for Gynecologic Pain","PAIN-GP: Project Assessing the Mechanisms and Impact of a Novel Cannabinoid Product for Gynecologic Pain","PAIN-GP","Inclusion Criteria:\n\n* Provides informed consent\n* Sex assigned female at birth\n* Capable of having menstrual cycles\n* Aged 21+\n* Endorses one of the following gynecologic pain conditions: endometriosis, adenomyosis, chronic pelvic inflammatory disease (PID)\n* Stable medication\u002Fpsychotherapy regimens for at least 3 months prior to starting the study, including hormonal contraceptives\n\nAdditional inclusion criteria for those in the PK subgroup:\n\n* Willingness to participate in the PK procedures (i.e., agree to an indwelling catheter with repeated blood collection)\n\nExclusion Criteria:\n\n* Meets criteria for DSM-5 classification of current substance use disorder, psychotic disorder, bipolar disorder, or an eating disorder\n* Currently uses cannabinoid products\n* Positive urine pregnancy test, are trying to become pregnant, or are currently breastfeeding\n* Presence of a serious or unstable medical illness, including liver\u002Fkidney disease, cardiovascular disease, neurological disorder, and conditions or medications that impact drug absorption or gastric emptying (e.g., GLP-1 agonists)\n* Comorbid neuropathic pain or cancer-related pain\n* Disclosure of a genetic polymorphism affecting CYP2C9 function\n* Liver function test (LFT) values \\>3x the upper limit of normal (ULN) at the baseline visit","FEMALE","21 Years",{"count":83,"type":84},60,"ESTIMATED","INTERVENTIONAL",[87,88],"PHASE1","PHASE2","Despite recent increases in both medical and recreational cannabis use in the United States and globally, little research has been conducted to determine the potential applications for womens health. A variety of medical cannabis and hemp-derived products on the marketplace claim to hold efficacy for many womens health-related conditions, including gynecologic pain. This 7-day study of individuals living with endometriosis, adenomyosis, or chronic pelvic inflammatory disease (PID), will identify specific targets and mechanisms underlying the potential impact of a hemp-derived, full-spectrum, high-CBD product in individuals with gynecologic pain.",[91,92,93],"Endometriosis","Adenomyosis","Chronic Pelvic Inflammatory Disease",[95,96,97,98,99,100],"cannabidiol","gynecologic pain","cannabinoid","endometriosis","adenomyosis","pelvic inflammatory disease","2026-07-22",{"date":103,"type":104},"2026-07-27","ACTUAL",{"date":106,"type":84},"2026-09",{"date":108,"type":84},"2029-01",{"name":66,"class":6},1]