Opioid Antagonism in Individuals Ascertained Through the Partners HealthCare Biobank

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.

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

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