Opioid Antagonism in Individuals Ascertained Through the Partners HealthCare Biobank

Stephanie B. Seminara, MD

Status and phase: Completed; Phase 1

Conditions: Reproductive Disorders

Treatments: Drug: Naloxone

Study type: Interventional

Funder types: Other

Identifiers

NCT04975347

313512

Details and patient eligibility

About

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

Full 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

Enrollment: 47 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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47 participants in 2 patient groups

Arm 1

No Intervention group

Description:

one period of frequent blood sampling with no medication administered

Arm 2

Experimental group

Description:

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.)

Treatment:

Drug: Naloxone