Opioid Antagonism in Individuals Ascertained Through the Partners HealthCare Biobank

NCT04975347 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 313512
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Reproductive Disorders

Keywords

naloxone

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Average change in LH pulse amplitude

  Two 12-hour periods

Study Arms (2)

Arm 1

NO INTERVENTION

one period of frequent blood sampling with no medication administered

Arm 2

EXPERIMENTAL

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

Interventions

Naloxone DRUG

One bolus and one infusion of naloxone

Arm 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stephanie B. Seminara, MD: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Interventions

Naloxone

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Stephanie Seminara, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, MGH Harvard Center for Reproductive Medicine

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: July 23, 2021
• Study Start: June 3, 2022
• Primary Completion: August 8, 2025
• Study Completion: August 8, 2025
• Last Updated: February 18, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)