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Completed

NCT Number: NCT04396730

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

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.

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Key information

Conditions

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

OHSU

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cannabidiol Oil

Drug

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

Other names: Cannabidiol + OCP

Placebo

Drug

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

Other names: Placebo + OCP

Combined Oral Contraceptive Pill

Drug

All participants will receive oral contraceptives

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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

  10. 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

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • Society of Family Planning

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 21, 2020
Registry last updated
Jul 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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