PAIN-GP: Project 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.