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60 Participants NeededMy employer runs this trial

High-CBD Cannabinoid Product for Gynecologic Pain

(PAIN-GP Trial)

SG
RS
Overseen ByRosie Smith, M.S.
Age: 18+
Sex: Female
Trial Phase: Phase 1 & 2
Sponsor: Staci Gruber, Ph.D.

What You Need to Know Before You Apply

What is the purpose of 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.

Are You a Good Fit for This Trial?

This trial is for adults with gynecologic pain caused by endometriosis, adenomyosis, or chronic pelvic inflammatory disease (PID). Participants should not have other major health issues that could interfere with the study.

Inclusion Criteria

I am able to have menstrual periods.
I was assigned female at birth.
I am 21 years old or older.
See 4 more

Exclusion Criteria

Currently uses cannabinoid products
Positive urine pregnancy test, are trying to become pregnant, or are currently breastfeeding
Meets criteria for DSM-5 classification of current substance use disorder, psychotic disorder, bipolar disorder, or an eating disorder
See 4 more

What Are the Treatments Tested in This Trial?

Interventions

  • Custom-formulated, high-CBD study product

Trial Overview

The study compares a custom-made, high-CBD hemp product to a placebo over 7 days to see if it helps reduce gynecologic pain. Participants are randomly assigned to either group.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: CBD study product: 1mL doseExperimental Treatment1 Intervention
Group II: CBD study product: 0.5mL doseExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Staci Gruber, Ph.D.

Lead Sponsor

Trials
2
Recruited
120+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials
886
Recruited
677,000+

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