RECRUITING

Contraceptive Hormone and Reward Measurement (CHARM Study)

Conditions

Oral Hormonal Contraceptive Use Neural Activity Mood Hedonic Function oral contraceptives reward processing

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Contraceptive Hormone and Reward Measurement (CHARM Study)

Quick Facts

Study Start:2021-10-01

Study Completion:2027-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05058872

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.).

Inclusion Criteria

Exclusion 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.

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.).

Contacts and Locations

Study Contact

Andrew M Novick, MD PhD

CONTACT

2672593730

andrew.m.novick@cuanschutz.edu

Principal Investigator

Andrew M Novick, MD PhD

PRINCIPAL_INVESTIGATOR

University of Colorado Denver Anschutz Medical Campus

Study Locations (Sites)

University of Colorado Denver Anschutz Medical Campus

Aurora, Colorado, 80045

United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

Andrew M Novick, MD PhD, PRINCIPAL_INVESTIGATOR, University of Colorado Denver Anschutz Medical Campus

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-01

Study Completion Date2027-03-31

Study Record Updates

Study Start Date2021-10-01

Study Completion Date2027-03-31

Terms related to this study

Keywords Provided by Researchers

oral contraceptives
mood
reward processing
hedonic function

Additional Relevant MeSH Terms

Oral Hormonal Contraceptive Use
Neural Activity
Mood
Hedonic Function