Actively Recruiting
Contraceptive Hormone and Reward Measurement (CHARM Study)
Led by University of Colorado, Denver · Updated on 2024-11-04
144
Participants Needed
1
Research Sites
286 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Purpose of this study: The purpose of this study is to learn more about how hormonal oral contraceptives affect brain processes and emotional wellbeing. Procedures: If participants agree to participate, the following will happen: 1. Eligibility visit (remote screening session) 2. If participants are eligible to participate in the study, they will be placed in one of two groups. If they are in the first group, they will be asked to take an oral contraception pill ("study drug") every day for 21 days. If they are in the second, they will take a placebo every day for 21 days. A placebo is a pill that looks like medicine but is not real and will have no medical effect on participants. Participants will not get to choose which group they are in, nor will they be told which group they are in. 3. During the three-week period in which participants will take either the study drug or placebo, they will be asked to complete daily check-in surveys on their computer or mobile device. 4. Participants will be asked to attend two additional visits over the course of about three weeks. At these visits, participants will be asked to undergo a urine drug screen, a blood draw, and a magnetic resonance imaging (MRI). They will also be asked to complete behavioral questionnaires.
CONDITIONS
Official Title
Contraceptive Hormone and Reward Measurement (CHARM Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 and older
- Right-handed
- Assigned female at birth
- Regular 21-35 day menstrual cycles for the past 6 months per self-report
- In generally good health per self-report; stable chronic medical conditions may be allowed at investigator discretion
- Willingness to abstain from intercourse or use non-hormonal backup contraception during the study
- Negative urine drug screen at baseline except prescribed marijuana or benzodiazepine as sleep aid
- Ability to abstain from caffeine and/or cannabis for 2 hours before MRI visits
- Access to reliable internet or cell phone data for daily questionnaires
- For remote screening, access to reliable internet, a computer, and private space
You will not qualify if you...
- History or presence of severe or unstable physical, neurological, or psychiatric disorders
- Lifetime history of psychotic disorders
- Substance use disorder not in remission for at least one year, except mild or cannabis-only disorders at investigator discretion
- Category 3 or 4 conditions or medications per CDC eligibility criteria for combined hormonal contraceptives
- Irregular menstrual periods
- Current tobacco smoking or smoking within past year
- Personal or family history of venous thromboembolism
- Known hypertensive disorder
- Current or past malignancy
- Migraines with aura
- Systolic blood pressure ≥140 or diastolic ≥90 at baseline
- Currently nursing an infant
- Known chromosomal or hormonal disorder affecting sex steroids
- Use of hormonal contraceptives currently or in past 3 months or medications affecting sex hormones
- Current pregnancy or pregnancy/delivery within past 6 months
- Intention to become pregnant during study
- Current use of psychotropic medications
- Claustrophobia
- Metal in body unsafe for MRI
- Weight over 300 pounds
- Conditions making MRI unsafe (e.g. aneurysm clip, pacemaker)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Colorado Denver Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
A
Andrew M Novick, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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