Clinical trial NCT04396730: Cannabidiol and Oral Contraceptive Pills: Exploring a Drug-Drug Interaction
Official title: Cannabidiol and Oral Contraceptive Pills: Exploring a Drug-Drug Interaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Contraception
Keywords: Cannabidiol
Combined oral contraceptives
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2020-05-21
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Maximum plasma concentration Ethinyl Estradiol
timeFrame: At the end of Cycle 1 (each cycle is 28 days)
measure: Maximum plasma concentration Ethinyl Estradiol
timeFrame: At the end of Cycle 3 (each cycle is 28 days)
measure: Maximum plasma concentration of Levonorgestrel
timeFrame: At the end of Cycle 1 (each cycle is 28 days)
measure: Maximum plasma concentration of Levonorgestrel
timeFrame: At the end of Cycle 3 (each cycle is 28 days)
Secondary outcomes:
measure: Time to maximum measured plasma concentration (Tmax)
timeFrame: At the end of Cycle 1 (each cycle is 28 days)
measure: Time to maximum measured plasma concentration (Tmax)
timeFrame: At the end of Cycle 3 (each cycle is 28 days)
measure: Time to maximum measured plasma concentration (Cmax)
timeFrame: At the end of Cycle 1 (each cycle is 28 days)
measure: Time to maximum measured plasma concentration (Cmax)
timeFrame: At the end of Cycle 3 (each cycle is 28 days)
measure: Final time taken for plasma concentration to be reduced by half (t1/2)
timeFrame: At the end of Cycle 1 (each cycle is 28 days)
measure: Final time taken for plasma concentration to be reduced by half (t1/2)
timeFrame: At the end of Cycle 3 (each cycle is 28 days)
measure: The area under the plasma concentration of LNG and EE vs. time curve (AUC)
timeFrame: At the end of Cycle 1 (each cycle is 28 days)
measure: The area under the plasma concentration of LNG and EE vs. time curve (AUC)
timeFrame: At the end of Cycle 3 (each cycle is 28 days)
measure: The first-order final elimination rate constant of EE and LNG
timeFrame: At the end of Cycle 1 (each cycle is 28 days)
measure: The first-order final elimination rate constant of EE and LNG
timeFrame: At the end of Cycle 3 (each cycle is 28 days)
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Shaalini Ramanadhan, MD
role: PRINCIPAL_INVESTIGATOR
References: