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

NCT04396730 | Completed Phase 4

• 1 other identifier: STUDY00020906
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Contraception

Keywords

Cannabidiol; Combined oral contraceptives

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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)

• 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 Outcomes (10)

• Time to maximum measured plasma concentration (Tmax)

  At the end of Cycle 1 (each cycle is 28 days)

• Time to maximum measured plasma concentration (Tmax)

  At the end of Cycle 3 (each cycle is 28 days)

• Time to maximum measured plasma concentration (Cmax)

  At the end of Cycle 1 (each cycle is 28 days)

• Time to maximum measured plasma concentration (Cmax)

  At the end of Cycle 3 (each cycle is 28 days)

• Final time taken for plasma concentration to be reduced by half (t1/2)

  At the end of Cycle 1 (each cycle is 28 days)

Study Arms (2)

Placebo followed by cannabidiol

PLACEBO COMPARATOR

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; Drug: Placebo; Drug: Combined oral contraceptive pill

Cannabidiol follow Placebo

EXPERIMENTAL

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; Drug: Placebo; Drug: Combined oral contraceptive pill

Interventions

Cannabidiol Oil DRUG

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

Also known as: Cannabidiol + OCP

Cannabidiol follow Placebo; Placebo followed by cannabidiol

Placebo DRUG

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

Also known as: Placebo + OCP

Cannabidiol follow Placebo; Placebo followed by cannabidiol

Combined oral contraceptive pill DRUG

All participants will receive oral contraceptives

Cannabidiol follow Placebo; Placebo followed by cannabidiol

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Society of Family Planning: collaborator

Study Sites (1)

OHSU

Portland, Oregon, 97239, United States

Location

MeSH Terms

Interventions

Cannabidiol; Contraceptives, Oral, Combined

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals; Drug Combinations; Pharmaceutical Preparations; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses

Study Officials

• Shaalini Ramanadhan, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double (Participant, Investigator)
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Instructor

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 21, 2020
• Study Start: April 8, 2020
• Primary Completion: March 2, 2022
• Study Completion: March 2, 2022
• Last Updated: July 11, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)