Effects of hormonal contraceptives on mood and brain activity

Contraceptive Hormone and Reward Measurement (CHARM Study)

This study is testing how taking hormonal birth control affects mood and brain activity in adult women.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 144 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: University of Colorado, Denver (other)
• Locations: 1 site (Aurora, Colorado)
• Trial ID: NCT05058872 on ClinicalTrials.gov

What this trial studies

This study investigates how oral hormonal contraceptives influence brain processes related to reward and emotional wellbeing in adult females. Participants will be randomly assigned to receive either the contraceptive pill or a placebo for 21 days, during which they will complete daily surveys and undergo functional magnetic resonance imaging (fMRI) to assess neural activity. The study aims to evaluate changes in mood, sexual function, and brain responses to pleasurable stimuli. By understanding these effects, the research seeks to provide insights into the psychological and neurological impacts of hormonal contraceptive use.

Who should consider this trial

Good fit: Ideal candidates are adult females aged 18 and older who have regular menstrual cycles and are in generally good health.

Not a fit: Patients who are not assigned female at birth or those with unstable chronic medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of the psychological effects of hormonal contraceptives, leading to better-informed choices for patients regarding their contraceptive options.

How similar studies have performed: Previous studies have explored the effects of hormonal contraceptives on mood and brain function, suggesting that this area of research has potential but may still yield novel insights.

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.).

Where this trial is running

Aurora, Colorado

• University of Colorado Denver Anschutz Medical Campus — Aurora, Colorado, United States (RECRUITING)

Study contacts

• Principal investigator: Andrew M Novick, MD PhD — University of Colorado Denver Anschutz Medical Campus
• Study coordinator: Andrew M Novick, MD PhD

Conditions: Oral Hormonal Contraceptive Use, Neural Activity, Mood, Hedonic Function, oral contraceptives, mood, reward processing, hedonic function