Cannabidiol and Oral Contraceptive Pills: Exploring a Drug-Drug Interaction

Last updated: July 7, 2023
Sponsor: Oregon Health and Science University
Overall Status: Completed

Phase

4

Condition

Contraception

Treatment

Combined oral contraceptive pill

Placebo

Cannabidiol Oil

Clinical Study ID

NCT04396730
STUDY00020906
  • Ages 18-35
  • Female
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to assess how Cannabidiol (CBD) impacts the effectiveness of oral contraceptive (birth control) pills and if CBD changes the possible side effects of birth control pills when CBD and birth control pills are taken at the same time.

This study explores the potential interaction between CBD and birth control pills by assessing serum levels of the contraceptive steroid hormones ethinyl estradiol and levonorgestrel in birth control pill users when they also use CBD.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have regular menses (every 21-35 days)
  • Not at risk for pregnancy (not sexually active, using a barrier method of birthcontrol, using a copper IUD for birth control, have a partner with a vasectomy, havehad a tubal ligation, or in a same sex relationship)
  • Generally healthy women between the age of 18 to 35 years old
  • English speaking

Exclusion

Exclusion Criteria:

  • Active users of hormonal contraception
  1. For combined methods, if they have recently stopped use, they must have had onenormal menstrual cycle
  2. For prior Depo-Medroxyprogesterone Acetate users, they must be off of themedication for 2 months and be having regular menstrual cycles
  • Pregnancy (less than 6 weeks prior), breastfeeding (less than 6 weeks prior), a. If participants have a normal menstrual cycle after these events, they may beconsidered for enrollment
  • Any absolute/relative contraindications to EE and LNG (MEC category 3 or 4 [12])including impaired liver function, history of deep venous thrombosis, hypertension (> 140/90), diabetes with vascular changes, migraines with aura or neurological changes,history of myocardial infarction, pulmonary embolus, stroke or breast cancer.
  • Use of CBD or THC products / Marijuana in the last 30 days
  • Use of a known CYP450 inhibitor or inducer (other medication)
  • BMI>25
  • Metabolic disorders including uncontrolled thyroid dysfunction and Polycystic OvarianSyndrome
  • Impaired liver or renal function
  • Smoking/vaping/e-cigarettes
  • Prior bariatric surgery
  • Decisional impairment
  • Incarceration

Study Design

Total Participants: 9
Treatment Group(s): 3
Primary Treatment: Combined oral contraceptive pill
Phase: 4
Study Start date:
April 08, 2020
Estimated Completion Date:
March 02, 2022

Study Description

Participants will be randomized to either the CBD or placebo for cycle one, followed by a washout cycle. For cycle three, participants will take the opposite of what they received in Cycle one. For example if they received CBD during cycle one they will take placebo for cycle 3.

Connect with a study center

  • OHSU

    Portland, Oregon 97239
    United States

    Site Not Available

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