Opioid Antagonism in Individuals Ascertained Through the Partners HealthCare Biobank

• Status: Enrolling by invitation
• Trial end date: 2025-02-28
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this study is to evaluate the effects of opioid antagonists on the hypothalamic-pituitary-gonadal axis in healthy subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Stephanie B. Seminara, MD
• Treatments: Naloxone

Criteria

• Normal puberty with respect to onset and pace

• No history of chronic disease

• No prescription medications for at least 2 months except for seasonal allergy medications

• No illicit drug use

• No excessive alcohol consumption (< 10 drinks/week)

• No history of a medication reaction requiring emergency medical care

• No difficulty with blood draws

• Not currently seeking fertility

• Body Mass Index (BMI) > 18.5 and < 30 kg/m2

• Normal blood pressure (BP) (systolic BP < 140 mm Hg, diastolic < 90 mm Hg)

• White blood cell, platelet counts, prolactin, and Thyroid Stimulating Hormone (TSH) between 90% of the lower limit and 110% of the upper limit of the reference range

• Normal hemoglobin

• Blood urea nitrogen (BUN), creatinine not elevated

• Aspartate aminotransferase (AST), alanine transaminase (ALT) <2x upper limit of reference range

• Normal levels of LH, Follicle Stimulating Hormone (FSH), and sex steroids (estradiol or testosterone)

• Negative urine drug screening panel

• For men:

• Normal erectile and ejaculatory function by report, no history of reproductive disorders (i.e. no history of cryptorchidism)

• Testicular volume >15 ml by Prader orchidometer

• For women:

• Menstrual cycles between 25 and 35 days in duration, at least 11 periods/year, with no more than 5 days variability in cycle duration

• No oral contraceptives for at least 1 month

• No evidence for androgen excess (hirsutism or acne)

• Not breastfeeding and not pregnant

• Negative serum human chorionic gonadotropin (hCG) pregnancy test at the time of screening, (additional urine pregnancy test will be conducted prior to drug administration)