Reproductive Disorders
Conditions
Keywords
naloxone
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 * Period 2: Blood sampling q10 min for up to 12 hours with concurrent administration of naloxone bolus followed by a naloxone infusion
Interventions
DRUGNaloxone
One bolus and one infusion of naloxone
Sponsors
Stephanie B. Seminara, MD
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average change in Luteinizing Hormone (LH) pulse frequency | Two 12-hour periods | Change in LH pulse frequency before and during naloxone infusion |
| Difference in Average LH Pulse Frequency | one 12-hour period | difference in LH pulse frequency between variant-carriers and control participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average change in LH pulse amplitude | Two 12-hour periods | Change in LH pulse amplitude before and during naloxone infusion |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORStephanie Seminara, MD
Massachusetts General Hospital
Outcome results
None listed