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NCT07728695

Overview

NCT ID: NCT07728695
Lead Sponsor: Staci Gruber, Ph.D.OTHER
Official Title: PAIN-GP: Project Assessing the Mechanisms and Impact of a Novel Cannabinoid Product for Gynecologic Pain
Brief 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.
Conditions: Endometriosis
Adenomyosis
Chronic Pelvic Inflammatory Disease

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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

Central Contacts: Staci Gruber, PhDContact
gruber@mclean.harvard.edu617-855-2762