Opioid Antagonism in Individuals Ascertained Through the Partners HealthCare Biobank

Phase 1

• Conditions: Reproductive Disorders
• Interventions: Drug: Naloxone

• Registration Number: NCT04975347
• Lead Sponsor: Stephanie B. Seminara, MD

Brief 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 with concurrent administration of naloxone bolus followed by a naloxone infusion

* Period 2: Blood sampling q10 min for up to 12 hours with concurrent administration of naloxone bolus followed by a naloxone infusion

Study Timeline

• Study First Submitted: 2021-07-15
• Study First Submitted QC: 2021-07-15
• Study First Posted: 2021-07-23
• Study Start: 2022-06-03
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-28
• Last Update Posted: 2025-03-04
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	Naloxone	one period of frequent blood sampling with no medication administered; one period of frequent blood sampling with IV administration of naloxone (one bolus and an infusion over an up to 12-hour period.)

Primary Outcome Measures

Name	Time	Method
Average change in Luteinizing Hormone (LH) pulse frequency	Two 12-hour periods	Change in LH pulse frequency before and during naloxone infusion
Difference in Average LH Pulse Frequency	one 12-hour period	difference in LH pulse frequency between variant-carriers and control participants

Secondary Outcome Measures

Name	Time	Method
Average change in LH pulse amplitude	Two 12-hour periods	Change in LH pulse amplitude before and during naloxone infusion

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States