Overview

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