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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Other
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: March 1, 2021

Interventions

  • Drug: Cannabidiol Oil
    • 400 mg Cannabidiol oil will be administered daily along with oral contraceptives daily for 24 days.
  • Drug: Placebo
    • Placebo will be administered daily along with oral contraceptives daily for 24 days.
  • Drug: Combined oral contraceptive pill
    • All participants will receive oral contraceptives

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo + OCP
    • Oral contraceptives will be taken daily for 24 days along with placebo (oral) once daily.
  • Experimental: Cannabidiol + OCP
    • Oral contraceptives will be taken daily for 24 days along with Cannabidiol 400mg once daily.

Clinical Trial Outcome Measures

Primary Measures

  • Maximum plasma concentration Ethinyl Estradiol
    • Time Frame: At the end of Cycle 1 and 3 (each cycle is 28 days)
    • Area under the plasma concentration vs time curve of ethinyl estradiol (EE) with and without concomitant CBD administration
  • Maximum plasma concentration of Levonorgestrel
    • Time Frame: At the end of Cycle 1 and 3 (each cycle is 28 days)
    • Area under the plasma concentration vs time curve of levonorgestrel (LNG) with and without concomitant CBD administration

Secondary Measures

  • Time to maximum measured plasma concentration (Tmax)
    • Time Frame: At the end of Cycle 1 and 3 (each cycle is 28 days)
    • Time to maximum measured plasma concentration of LNG and EE. (Tmax)
  • Time to maximum measured plasma concentration (Cmax)
    • Time Frame: At the end of Cycle 1 and 3 (each cycle is 28 days)
    • Time to maximum measured plasma concentration of LNG and EE (Cmax)
  • Final time taken for plasma concentration to be reduced by half (t1/2)
    • Time Frame: At the end of Cycle 1 and 3 (each cycle is 28 days)
    • Final time taken for plasma concentration of LNG and EE to be reduced by half (t1/2)
  • The area under the plasma concentration of LNG and EE vs. time curve (AUC)
    • Time Frame: At the end of Cycle 1 and 3 (each cycle is 28 days)
    • The area under the plasma concentration of LNG and EE vs. time curve (AUC)
  • The first-order final elimination rate constant of EE and LNG
    • Time Frame: At the end of Cycle 1 and 3 (each cycle is 28 days)
    • The first-order final elimination rate constant of EE and LNG

Participating in This Clinical Trial

Inclusion Criteria

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

Exclusion Criteria

  • Active users of hormonal contraception

1. For combined methods, if they have recently stopped use, they must have had one normal menstrual cycle

2. For prior Depo-Medroxyprogesterone Acetate users, they must be off of the medication 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 be considered 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 Ovarian Syndrome
  • Impaired liver or renal function
  • Smoking/vaping/e-cigarettes
  • Prior bariatric surgery
  • Decisional impairment
  • Incarceration

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Oregon Health and Science University
  • Collaborator
    • Society of Family Planning
  • Provider of Information About this Clinical Study
    • Principal Investigator: Shaalini Ramanadhan, Clinical Instructor – Oregon Health and Science University

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