NCT04975347

Opioid Antagonism in Individuals Ascertained Through the Partners HealthCare Biobank

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Stephanie B. Seminara, MD · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

Arm 1 Assignment: Individuals will be assigned to group 1 or group 2 based on their genetic features. Arm 2 Assignment: Each study subject will serve as their own control. Delivery of Interventions: * Prior to the study visit, subjects will undergo a review of their medical history and screening laboratories. * During the study, the subjects will complete the following * Arm 1: Undergo frequent blood sampling for up to 12 hours * Arm 2: * Period 1: Blood sampling q10 min for up to 12 hours * Period 2: Blood sampling q10 min for up to 12 hours with concurrent administration of naloxone bolus followed by a naloxone infusion

Conditions

• Reproductive Disorders

Interventions

Type	Name	Description
DRUG	Naloxone	One bolus and one infusion of naloxone

Timeline

• Start date: 2022-06-03
• Primary completion: 2025-08-08
• Completion: 2025-08-08
• First posted: 2021-07-23
• Last updated: 2026-02-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study