NCT05787470 State of Hormones Impact Nociceptive Expression
| NCT ID | NCT05787470 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alabama at Birmingham |
| Condition | Pain |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-03-01 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2023-03-01 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The Investigators have recently published on differences in pain sensitivity measures between cis and trans individuals in the local area. The investigators observed the anticipated differences in pain sensitivity between CM and CW (CW \> CM), but found that the TW were phenotypically similar to CW in all measures. However, the investigators did not assess hormone level, nor did the investigators recruit TM participants. Here, with the assistance of two local community group stakeholders the investigators will recruit the following groups: CM, CW, TM+T (currently taking exogenous testosterone), TW+E (exogenous estradiol), TM, and TW (n=20/group). The investigators will use quantitative sensory testing to assess sensitivity to cold, pressure, and heat via standardized protocols. Blood samples will be taken for assessment of stress and reproductive hormone levels, immune cell populations and stimulated cytokine release. Finally, questionnaires will measure pain state, quality of life (QOL), voice QOL, body image, appearance, self-reported health, masculinity/femininity, community connectedness, gender role, sleep, depression, social support, adverse childhood experiences and stigma.
Eligibility Criteria
Inclusion Criteria: * self-identification as one of the above gender identities * understanding of verbal and written English. * participants that have been on/off hormone treatment for at least 6 months Exclusion Criteria: * pain in at least 3/7 days/week for the past 3 months * HIV positive diagnosis * cardiovascular or pulmonary disease * regular use of opioid pain medications * uncontrolled hypertension (i.e. SBP/DBP of \> 150/95) * current illness accompanied by fever (body temperature \>38 °C) * prostatectomy, hysterectomy or oophorectomy * hospitalization due to psychiatric illness within the last 6 months.
Contact & Investigator
Robert Sorge, Phd
PRINCIPAL INVESTIGATOR
University of Alabama at Birmingham Department of Psychology
Frequently Asked Questions
Who can join the NCT05787470 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05787470 currently recruiting?
Yes, NCT05787470 is actively recruiting participants. Contact the research team at tquinn@uab.edu for enrollment information.
Where is the NCT05787470 trial being conducted?
This trial is being conducted at Birmingham, United States.
Who is sponsoring the NCT05787470 clinical trial?
NCT05787470 is sponsored by University of Alabama at Birmingham. The principal investigator is Robert Sorge, Phd at University of Alabama at Birmingham Department of Psychology. The trial plans to enroll 120 participants.