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

Oregon Health & Science University (OHSU)

Status and phase: Completed; Phase 4

Conditions: Contraception

Treatments: Drug: Placebo; Drug: Combined oral contraceptive pill; Drug: Cannabidiol Oil

Study type: Interventional

Funder types: Other

Identifiers

NCT04396730

STUDY00020906

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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9 participants in 2 patient groups, including a placebo group

Placebo followed by cannabidiol

Placebo Comparator group

Description:

Oral contraceptives will be taken daily for 24 days along with placebo (oral) once daily for cycle 1. During cycle 3, cannabidiol will be taken once daily along with OCPs.

Treatment:

Drug: Combined oral contraceptive pill

Drug: Cannabidiol Oil

Drug: Placebo

Cannabidiol follow Placebo

Experimental group

Description:

Oral contraceptives will be taken daily for 24 days along with Cannabidiol 400mg once daily for cycle 1. During cycle 3. placebo will be taken once daily along with OCPs.

Treatment:

Drug: Combined oral contraceptive pill

Drug: Cannabidiol Oil

Drug: Placebo