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

NCT ID: NCT04396730

Last Updated: 2023-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-08
• Study Completion Date: 2022-03-02

Brief 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.

Detailed 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.

Conditions

Contraception

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Placebo followed by cannabidiol

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.

Group Type: PLACEBO_COMPARATOR

Cannabidiol Oil

Intervention Type: DRUG

400 mg Cannabidiol oil will be administered daily along with oral contraceptives daily for 24 days.

Placebo

Intervention Type: DRUG

Placebo will be administered daily along with oral contraceptives daily for 24 days.

Combined oral contraceptive pill

Intervention Type: DRUG

All participants will receive oral contraceptives

Cannabidiol follow Placebo

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.

Group Type: EXPERIMENTAL

Cannabidiol Oil

Intervention Type: DRUG

400 mg Cannabidiol oil will be administered daily along with oral contraceptives daily for 24 days.

Placebo

Intervention Type: DRUG

Placebo will be administered daily along with oral contraceptives daily for 24 days.

Combined oral contraceptive pill

Intervention Type: DRUG

All participants will receive oral contraceptives

Interventions

Cannabidiol Oil

400 mg Cannabidiol oil will be administered daily along with oral contraceptives daily for 24 days.

Intervention Type: DRUG

Placebo

Placebo will be administered daily along with oral contraceptives daily for 24 days.

Intervention Type: DRUG

Combined oral contraceptive pill

All participants will receive oral contraceptives

Intervention Type: DRUG

Other Intervention Names

Cannabidiol + OCP; Placebo + OCP

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Society of Family Planning

OTHER

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Shaalini Ramanadhan

Clinical Instructor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shaalini Ramanadhan, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

OHSU

Portland, Oregon, United States

Countries

United States

Other Identifiers

STUDY00020906

Identifier Type: -

Identifier Source: org_study_id