Assessing the Mechanisms and Impact of a Novel Cannabinoid Product for Gynecologic Pain
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age21+
SponsorStaci Gruber, Ph.D.
About this trial
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.
Eligibility criteria
Qualifiers
Provides informed consent
Sex assigned female at birth
Capable of having menstrual cycles
Aged 21+
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Custom-formulated, high-CBD study product
- Placebo
Treatment groups
60 Participants
are divided into 3 treatment groupsSponsors and collaborators
Staci Gruber, Ph.D.
Lead sponsor
Mclean Hospital
Sponsor institution
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
Source ClinicalTrials.gov