Contraceptive Hormone and Reward Measurement (CHARM Study)

Launched by UNIVERSITY OF COLORADO, DENVER · Sep 17, 2021

Keywords

ClinConnect Summary

The CHARM Study is a clinical trial designed to understand how oral hormonal contraceptives affect the brain and emotions. Researchers want to learn more about how these contraceptives might influence mood and feelings of pleasure. If you decide to participate, you will first have a remote screening to see if you're eligible. Eligible participants will be assigned to one of two groups: one will take the actual contraceptive pill every day for 21 days, while the other will take a placebo, which looks like the pill but has no active ingredients. Participants won’t know which group they are in.

To qualify for the study, you need to be at least 18 years old, assigned female at birth, and have regular menstrual cycles. You should generally be in good health, willing to avoid sexual intercourse or use non-hormonal contraception during the study, and able to complete daily online surveys. Throughout the study, you’ll also attend two additional visits for urine and blood tests, as well as an MRI scan to check brain activity. If you have certain medical conditions or a history of specific health issues, you might not be eligible, so it’s important to discuss any concerns with the study team.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Aged 18 and older;
• • 2. Right-handed;
• • 3. Assigned female at birth;
• • 4. Regular 21-35 day menstrual cycles for the past 6 months per self-report;
• • 5. In generally good health per self-report. Those with a chronic medical condition may participate at the discretion of the principal investigator if the condition is stable;
• • 6. Willingness to abstain from intercourse or use a non-hormonal back-up method of contraception (e.g., condoms) during the entire course of the study;
• • 7. Negative urine drug screen, excepting marijuana or benzodiazepine that is being prescribed by a physician as a sleep aid, assessed at the baseline visit;
• • 8. Ability to abstain from caffeine and/or cannabis for 2 hours prior to functional Magnetic Resonance Imaging (fMRI) scan visits;
• • 9. Access to a reliable internet connection or cell phone data to complete daily questionnaires;
• • 10. For those wishing to complete study screening session remotely: access to a reliable internet connection, computer to complete electronic consent and a private space to complete the session.
• Exclusion Criteria:
• • 1. Presence or history of severe or unstable physical, neurological (per health history interview) or psychiatric disorders (assessed by Miniature International Neuropsychiatric Interview (MINI) but per Diagnostic and Statistical Manual of Mental Disorders - fifth edition (DSM-V) criteria, and the discretion of the principal investigator);
• • 2. Lifetime history of psychotic disorders;
• • 3. History of substance use disorder that has not been in remission (as defined by a substance free period of at least one year). However, individuals with mild disorders, disorders solely limited to cannabis, and/or those who have achieved close to one year of remission may be eligible at the discretion of the PI;
• • 4. Presence or history of any category 3 or 4 conditions or medications per the CDC's (Centers for Disease Control and Prevention) Medical Eligibility Criteria for Contraceptive Use pertaining to combined hormonal contraceptive methods as per self-report and reviewed by the principal investigator;
• • 5. Irregular menstrual periods per self-report;
• • 6. Any current tobacco smoking (former smokers are eligible so long as their quit date was greater than one year ago);
• • 7. Any personal or family history of a venous thromboembolism;
• • 8. Known diagnosis of hypertensive disorder;
• • 9. Any current or past history of malignancy;
• • 10. Migraines with aura;
• • 11. Systolic blood pressure greater than or equal to 140 or diastolic pressure greater than or equal to 90 taken at baseline visit;
• • 12. Currently nursing an infant;
• • 13. Known chromosomal or hormonal disorder affecting sex steroids;
• • 14. Use of hormonal contraceptives currently or in the past 3 months, or use of medications that directly affect sex hormones (i.e. gonadotropin releasing hormone agonists, selective estrogen receptor modifiers);
• • 15. Current pregnancy or pregnancy/delivery in the past six months;
• • 16. Intention to become pregnant during study participation;
• • 17. Current use of psychotropic medication;
• • 18. Claustrophobia;
• • 19. Metal in body unsafe for magnetic resonance imaging;
• • 20. Weight over 300 pounds;
• • 21. Conditions that would make magnetic resonance imaging unsafe for participants (i.e. aneurysm clip, cardiac pacemaker, etc.).