Opioid Antagonism in Individuals Ascertained Through the Partners HealthCare Biobank

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

Study Overview

• Status: Completed
• Conditions: Reproductive Disorders
• Intervention / Treatment: Drug: Naloxone

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

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion

• Age 18-45 years (women) OR 18-60 years (men)
• Genetic sequencing data available via Mass General Brigham Biobank
• All medical conditions stable and well controlled
• If applicable, willing to use birth control methods (as approved by a study medical professional) during protocol participation
• Normal blood pressure (systolic BP < 140 mm Hg, diastolic < 90 mm Hg)
• Negative urine drug screening panel
• Hemoglobin within sex-specific reference range
• For women, negative serum hCG pregnancy test

Exclusion

• Any condition (medical, mental, or behavioral) that, in the opinion of a study investigator, would likely interfere with participation in/completion of the protocol
• Current or recent use of a medication (including hormonal replacement) that, in the opinion of a study investigator, can modulate the reproductive axis and, if applicable, unwilling to complete an appropriate washout for that particular medication and its method of administration
• Current or recent use of a medication that affects the opioid pathway
• Active illicit drug use
• Excessive alcohol consumption (> 10 drinks/week)
• For women, pregnant or breastfeeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Arm 1; one period of frequent blood sampling with no medication administered
Experimental: Arm 2; 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.)	Drug: Naloxone; One bolus and one infusion of naloxone

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average change in LH pulse amplitude	Change in LH pulse amplitude before and during naloxone infusion	Two 12-hour periods

Collaborators and Investigators

• Sponsor: Stephanie B. Seminara, MD
• Investigators: Principal Investigator: Stephanie Seminara, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2022
• Primary Completion (Actual): August 8, 2025
• Study Completion (Actual): August 8, 2025

Study Registration Dates

• First Submitted: July 15, 2021
• First Submitted That Met QC Criteria: July 15, 2021
• First Posted (Actual): July 23, 2021

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: naloxone
• Additional Relevant MeSH Terms: Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Alkaloids; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, Bridged-Ring; Phenanthrenes; Naloxone
• Other Study ID Numbers: 313512

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No