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

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Oregon Health and Science University
• Collaborator: Society of Family Planning
• Treatments: Cannabidiol; Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined; Epidiolex

Criteria

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