Health TrialsbyHealthPanel

Assessing the Mechanisms and Impact of a Novel Cannabinoid Product for Gynecologic Pain

ConditionsEndometriosisAdenomyosisChronic Pelvic Inflammatory Disease
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Custom-formulated, high-CBD study product

    Drug

    2 doses of the high-CBD study product will be used, compared to placebo.

  • Placebo

    Drug

    Placebo study product.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: CBD study product: 1mL doseExperimental treatment 1 intervention
Group B: CBD study product: 0.5mL doseExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Quantification of parent CBD and its primary metabolites, 7-COOH-CBD and 7-OH-CBD, as well as metabolite-to-parent drug exposure ratios (MPR)

Time frame
Baseline, 7 days
2

Inflammatory markers

Time frame
Baseline, 7 days
3

Circulating anandamide (AEA)

Time frame
Baseline, 7 days

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Staci Gruber, Ph.D.

Lead sponsor

Mclean Hospital

Sponsor institution

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Source ClinicalTrials.gov
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