Opioid blocker trial probes hormone secrets in biobank volunteers
NCT ID NCT04975347
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This completed Phase 1 study looked at how naloxone, an opioid blocker, affects reproductive hormones in 47 healthy adults. Participants had genetic data available from the Mass General Brigham Biobank. Researchers measured changes in luteinizing hormone pulses before and during naloxone infusion to understand the brain's control of reproduction.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Naloxone
- What this could lead to
- If successful, this could help explain how opioid blockers influence reproductive hormone regulation in people with certain genetic variants.
- What could go wrong
- This is a small, early-phase study in healthy volunteers, so results may not apply to people with reproductive disorders or lead to a treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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47 people
The number who actually took part.
- Started
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Jun 2022
- Finished
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Aug 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.