ContraceptionPhase 4NCT04396730
Cannabidiol and Oral Contraceptive Pills: Exploring a Drug-Drug Interaction
A Phase 4 study testing Cannabidiol Oil and Combined oral contraceptive pill in people with Contraception, run by Oregon Health and Science University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Cannabidiol Oil and Combined oral contraceptive pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2020to 2 Mar 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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),
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Contraception
- Being tested
- Cannabidiol Oil, Placebo, Combined oral contraceptive pill
- Keywords
- Cannabidiol, Combined oral contraceptives
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabidiol OilDrug
Also called Cannabidiol + OCP
400 mg Cannabidiol oil will be administered daily along with oral contraceptives daily for 24 days.
PlaceboDrug
Also called Placebo + OCP
Placebo will be administered daily along with oral contraceptives daily for 24 days.
Combined oral contraceptive pillDrug
All participants will receive oral contraceptives
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Cannabidiol Oil; Drug: Placebo; Drug: Combined oral contraceptive pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration Ethinyl Estradiol
Area under the plasma concentration vs time curve of ethinyl estradiol (EE)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: At the end of Cycle 3 (each cycle is 28 days)
Secondary outcomes (10)
Time to maximum measured plasma concentration (Tmax)
Time to maximum measured plasma concentration of LNG and EE. (Tmax)
Measured: At the end of Cycle 1 (each cycle is 28 days)
Time to maximum measured plasma concentration (Tmax)
Time to maximum measured plasma concentration of LNG and EE. (Tmax)
Measured: At the end of Cycle 3 (each cycle is 28 days)
Time to maximum measured plasma concentration (Cmax)
Time to maximum measured plasma concentration of LNG and EE (Cmax)
Measured: At the end of Cycle 1 (each cycle is 28 days)
Time to maximum measured plasma concentration (Cmax)
Time to maximum measured plasma concentration of LNG and EE (Cmax)
Measured: At the end of Cycle 3 (each cycle is 28 days)
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)
Measured: At the end of Cycle 1 (each cycle is 28 days)
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)
Measured: 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 area under the plasma concentration of LNG and EE vs. time curve (AUC)
Measured: 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)
Measured: At the end of Cycle 3 (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
Measured: 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
Measured: At the end of Cycle 3 (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start8 Apr 2020
- Primary completion2 Mar 2022
- Study completion2 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning
- Responsible party
- Principal investigator, Shaalini Ramanadhan, Oregon Health and Science University
- Investigators
- Shaalini Ramanadhan, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04396730
- Sponsor's protocol ID
- STUDY00020906
- Status last verified
- Jul 2023
- First submitted
- 29 Apr 2020
- Last updated
- 11 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabidiol and Oral Contraceptive Pills: Exploring a Drug-Drug Interaction
- ClinicalTrials.gov ID
- NCT04396730
- Acronym / sponsor ID
- STUDY00020906
- Conditions
- Contraception
- Keywords
- Cannabidiol, Combined oral contraceptives
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Society of Family Planning
- Study start
- 8 Apr 2020 (actual)
- Primary completion
- 2 Mar 2022 (actual)
- Study completion
- 2 Mar 2022 (actual)
- First posted
- 21 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo followed by cannabidiol | Placebo comparator | Drug: Cannabidiol Oil, Drug: Placebo, Drug: Combined oral contraceptive pillOral 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. |
| Cannabidiol follow Placebo | Experimental | Drug: Cannabidiol Oil, Drug: Placebo, Drug: Combined oral contraceptive pillOral 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- Active users of hormonal contraception
- Pregnancy (less than 6 weeks prior), breastfeeding (less than 6 weeks prior),
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabidiol OilAlso: Cannabidiol + OCP400 mg Cannabidiol oil will be administered daily along with oral contraceptives daily for 24 days. | Drug | Cannabidiol follow Placebo, Placebo followed by cannabidiol |
| PlaceboAlso: Placebo + OCPPlacebo will be administered daily along with oral contraceptives daily for 24 days. | Drug | Cannabidiol follow Placebo, Placebo followed by cannabidiol |
| Combined oral contraceptive pillAll participants will receive oral contraceptives | Drug | Cannabidiol follow Placebo, Placebo followed by cannabidiol |
Primary outcome
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)
10 secondary outcomes
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 (Tmax)
Time frame: At the end of Cycle 3 (each cycle is 28 days)
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 (Cmax)
Time frame: At the end of Cycle 3 (each cycle is 28 days)
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 to be reduced by half (t1/2)
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)
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)
Time frame: At the end of Cycle 3 (each cycle is 28 days)
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
Time frame: At the end of Cycle 3 (each cycle is 28 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaalini Ramanadhan, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cannabidiol Oil and Combined oral contraceptive pill in people with Contraception, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum plasma concentration Ethinyl Estradiol (time frame: At the end of Cycle 1 (each cycle is 28 days)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2023.