PAIN-GP: Project Assessing the Mechanisms and Impact of a Novel Cannabinoid Product for Gynecologic Pain
Staci Gruber, Ph.D.
Summary
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.
Description
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 hospita…
Eligibility
- Age range
- 21+ years
- Sex
- Female
- Healthy volunteers
- No
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…
Interventions
- DrugCustom-formulated, high-CBD study product
2 doses of the high-CBD study product will be used, compared to placebo.
- DrugPlacebo
Placebo study product.
Location
- McLean HospitalBelmont, Massachusetts