Assessing the Mechanisms and Impact of a Novel Cannabinoid Product for Gynecologic Pain

This study is a double-blind, placebo-controlled clinical trial of a high-cannabidiol (CBD) sublingual product in individuals with gynecologic pain relating to endometriosis, adenomyosis, or chronic pelvic inflammatory disease (PID). The study consists of 3 visits. Participants will be pre-screened by phone to determine initial eligibility, then will come to McLean Hospital for a screening visit. During the screening visit, participants will complete a clinical interview, medical screening, a urine sample, blood draw, and a questionnaire. If approved, participants will come back to the hospital for a baseline visit, and will complete a urine sample, blood draw, questionnaires, and a sensory test. Enrolled participants will be randomized to receive one of two doses of high-CBD study product or placebo, and instructed to self-administer and track their use over the course of one week. Participants will return to the hospital for their final visit consisting of additional urine and blood samples, questionnaires, and sensory testing.

A subset of participants will have the option to complete pharmacokinetic/pharmacodynamic (PK/PD) studies, consisting of additional questionnaires and collection of blood samples through repeated blood draws before and after self-administration of the study product, at the baseline and final study visits. These additional procedures will take up to 8 hours per visit and participants who complete these procedures will receive additional compensation.

Inclusion criteria

• Provides informed consent
• Sex assigned female at birth
• Capable of having menstrual cycles
• Aged 21+
• Endorses one of the following gynecologic pain conditions: endometriosis, adenomyosis, chronic pelvic inflammatory disease (PID)
• Stable medication/psychotherapy regimens for at least 3 months prior to starting the study, including hormonal contraceptives

Additional inclusion criteria for those in the PK subgroup:

• Willingness to participate in the PK procedures (i.e., agree to an indwelling catheter with repeated blood collection)

Exclusion criteria

• Meets criteria for DSM-5 classification of current substance use disorder, psychotic disorder, bipolar disorder, or an eating disorder
• Currently uses cannabinoid products
• Positive urine pregnancy test, are trying to become pregnant, or are currently breastfeeding
• Presence of a serious or unstable medical illness, including liver/kidney disease, cardiovascular disease, neurological disorder, and conditions or medications that impact drug absorption or gastric emptying (e.g., GLP-1 agonists)
• Comorbid neuropathic pain or cancer-related pain
• Disclosure of a genetic polymorphism affecting CYP2C9 function
• Liver function test (LFT) values >3x the upper limit of normal (ULN) at the baseline visit