Clinical trial NCT04975347: Opioid Antagonism in Individuals Ascertained Through the Partners HealthCare Biobank
Official title: Opioid Antagonism in Individuals Ascertained Through the Partners HealthCare Biobank
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
Conditions: Reproductive Disorders
Keywords: naloxone
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2021-07-23
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

Eligibility 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

Primary outcomes:
measure: Average change in Luteinizing Hormone (LH) pulse frequency
timeFrame: Two 12-hour periods
measure: Difference in Average LH Pulse Frequency
timeFrame: one 12-hour period
Secondary outcomes:
measure: Average change in LH pulse amplitude
timeFrame: Two 12-hour periods
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Stephanie Seminara, MD
role: PRINCIPAL_INVESTIGATOR
References: