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

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04396730
• Other study ID #: STUDY00020906
• Status: Completed
• Phase: Phase 4
• Start date: April 8, 2020
• Est. completion date: March 2, 2022

Study information

• Verified date: July 2023
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: March 2, 2022
• Est. primary completion date: March 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

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

Locations

Country	Name	City	State
United States	OHSU	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	Society of Family Planning

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum plasma concentration Ethinyl Estradiol	Area under the plasma concentration vs time curve of ethinyl estradiol (EE)	At the end of Cycle 1 (each cycle is 28 days)
Primary	Maximum plasma concentration Ethinyl Estradiol	Area under the plasma concentration vs time curve of ethinyl estradiol (EE)	At the end of Cycle 3 (each cycle is 28 days)
Primary	Maximum plasma concentration of Levonorgestrel	Area under the plasma concentration vs time curve of levonorgestrel (LNG)	At the end of Cycle 1 (each cycle is 28 days)
Primary	Maximum plasma concentration of Levonorgestrel	Area under the plasma concentration vs time curve of levonorgestrel (LNG)	At the end of Cycle 3 (each cycle is 28 days)
Secondary	Time to maximum measured plasma concentration (Tmax)	Time to maximum measured plasma concentration of LNG and EE. (Tmax)	At the end of Cycle 1 (each cycle is 28 days)
Secondary	Time to maximum measured plasma concentration (Tmax)	Time to maximum measured plasma concentration of LNG and EE. (Tmax)	At the end of Cycle 3 (each cycle is 28 days)
Secondary	Time to maximum measured plasma concentration (Cmax)	Time to maximum measured plasma concentration of LNG and EE (Cmax)	At the end of Cycle 1 (each cycle is 28 days)
Secondary	Time to maximum measured plasma concentration (Cmax)	Time to maximum measured plasma concentration of LNG and EE (Cmax)	At the end of Cycle 3 (each cycle is 28 days)
Secondary	Final time taken for plasma concentration to be reduced by half (t1/2)	Final time taken for plasma concentration of LNG and EE to be reduced by half (t1/2)	At the end of Cycle 1 (each cycle is 28 days)
Secondary	Final time taken for plasma concentration to be reduced by half (t1/2)	Final time taken for plasma concentration of LNG and EE to be reduced by half (t1/2)	At the end of Cycle 3 (each cycle is 28 days)
Secondary	The area under the plasma concentration of LNG and EE vs. time curve (AUC)	The area under the plasma concentration of LNG and EE vs. time curve (AUC)	At the end of Cycle 1 (each cycle is 28 days)
Secondary	The area under the plasma concentration of LNG and EE vs. time curve (AUC)	The area under the plasma concentration of LNG and EE vs. time curve (AUC)	At the end of Cycle 3 (each cycle is 28 days)
Secondary	The first-order final elimination rate constant of EE and LNG	The first-order final elimination rate constant of EE and LNG	At the end of Cycle 1 (each cycle is 28 days)
Secondary	The first-order final elimination rate constant of EE and LNG	The first-order final elimination rate constant of EE and LNG	At the end of Cycle 3 (each cycle is 28 days)