Cannabidiol and Oral Contraceptive Pills: Exploring a Drug-Drug Interaction
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04396730 |
Recruitment Status :
Active, not recruiting
First Posted : May 21, 2020
Last Update Posted : September 30, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Contraception | Drug: Cannabidiol Oil Drug: Placebo Drug: Combined oral contraceptive pill | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
Masking Description: | Double (Participant, Investigator) |
Primary Purpose: | Other |
Official Title: | Cannabidiol and Oral Contraceptive Pills: Exploring a Drug-Drug Interaction |
Actual Study Start Date : | April 8, 2020 |
Actual Primary Completion Date : | March 2, 2022 |
Estimated Study Completion Date : | March 2, 2023 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: 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.
|
Drug: Cannabidiol Oil
400 mg Cannabidiol oil will be administered daily along with oral contraceptives daily for 24 days.
Other Name: Cannabidiol + OCP Drug: Placebo Placebo will be administered daily along with oral contraceptives daily for 24 days.
Other Name: Placebo + OCP Drug: Combined oral contraceptive pill All participants will receive oral contraceptives |
Experimental: 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.
|
Drug: Cannabidiol Oil
400 mg Cannabidiol oil will be administered daily along with oral contraceptives daily for 24 days.
Other Name: Cannabidiol + OCP Drug: Placebo Placebo will be administered daily along with oral contraceptives daily for 24 days.
Other Name: Placebo + OCP Drug: Combined oral contraceptive pill All participants will receive oral contraceptives |
- Maximum plasma concentration Ethinyl Estradiol [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]Area under the plasma concentration vs time curve of ethinyl estradiol (EE)
- Maximum plasma concentration Ethinyl Estradiol [ Time Frame: At the end of Cycle 3 (each cycle is 28 days) ]Area under the plasma concentration vs time curve of ethinyl estradiol (EE)
- Maximum plasma concentration of Levonorgestrel [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]Area under the plasma concentration vs time curve of levonorgestrel (LNG)
- Maximum plasma concentration of Levonorgestrel [ Time Frame: At the end of Cycle 3 (each cycle is 28 days) ]Area under the plasma concentration vs time curve of levonorgestrel (LNG)
- Time to maximum measured plasma concentration (Tmax) [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]Time to maximum measured plasma concentration of LNG and EE. (Tmax)
- Time to maximum measured plasma concentration (Tmax) [ Time Frame: At the end of Cycle 3 (each cycle is 28 days) ]Time to maximum measured plasma concentration of LNG and EE. (Tmax)
- Time to maximum measured plasma concentration (Cmax) [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]Time to maximum measured plasma concentration of LNG and EE (Cmax)
- Time to maximum measured plasma concentration (Cmax) [ Time Frame: At the end of Cycle 3 (each cycle is 28 days) ]Time to maximum measured plasma concentration of LNG and EE (Cmax)
- Final time taken for plasma concentration to be reduced by half (t1/2) [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]Final time taken for plasma concentration of LNG and EE to be reduced by half (t1/2)
- Final time taken for plasma concentration to be reduced by half (t1/2) [ Time Frame: At the end of Cycle 3 (each cycle is 28 days) ]Final time taken for plasma concentration of LNG and EE to be reduced by half (t1/2)
- The area under the plasma concentration of LNG and EE vs. time curve (AUC) [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]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) [ Time Frame: At the end of Cycle 3 (each cycle is 28 days) ]The area under the plasma concentration of LNG and EE vs. time curve (AUC)
- The first-order final elimination rate constant of EE and LNG [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]The first-order final elimination rate constant of EE and LNG
- The first-order final elimination rate constant of EE and LNG [ Time Frame: At the end of Cycle 3 (each cycle is 28 days) ]The first-order final elimination rate constant of EE and LNG

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 35 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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
- For combined methods, if they have recently stopped use, they must have had one normal menstrual cycle
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04396730
United States, Oregon | |
OHSU | |
Portland, Oregon, United States, 97239 |
Principal Investigator: | Shaalini Ramanadhan, MD | Oregon Health and Science University |
Responsible Party: | Shaalini Ramanadhan, Clinical Instructor, Oregon Health and Science University |
ClinicalTrials.gov Identifier: | NCT04396730 |
Other Study ID Numbers: |
STUDY00020906 |
First Posted: | May 21, 2020 Key Record Dates |
Last Update Posted: | September 30, 2022 |
Last Verified: | September 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Cannabidiol Combined oral contraceptives |
Cannabidiol Contraceptive Agents Contraceptives, Oral Contraceptives, Oral, Combined |
Reproductive Control Agents Physiological Effects of Drugs Anticonvulsants Contraceptive Agents, Female |