Naloxone for Reproductive Disorders

Overseen By Study Coordinator

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Stephanie B. Seminara, MD

Must not be taking: Hormonal replacements, Opioid pathway

Disqualifiers: Illicit drug use, Excessive alcohol, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 12 hours per period

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to examine how naloxone, a medication that blocks opioid effects, impacts the body's hormone system related to reproduction. Researchers seek to understand this process by comparing individuals who receive naloxone with those who do not. The trial seeks healthy men and women with stable medical conditions who are willing to participate in regular blood sampling. Participants should not use drugs or medications that affect hormones or opioids. Those experiencing reproductive issues and meeting these criteria may find this trial suitable. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to contribute to groundbreaking research.

Do I need to stop my current medications for the trial?

You may need to stop taking certain medications if they affect the reproductive system or the opioid pathway. If you are on such medications, you might have to go through a washout period (time without taking those medications) before joining the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that naloxone is generally safe to use. Studies involving pregnant individuals have found no major birth defects linked to naloxone. It is also considered safe when combined with other medications, like buprenorphine, during pregnancy. Hospitals often use naloxone to prevent overdose-related problems, suggesting its safety for broader use. Although these studies do not specifically address reproductive issues, they support naloxone's overall safety in humans. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for reproductive disorders?

Unlike most treatments for reproductive disorders that focus on hormonal therapies or surgical interventions, naloxone is unique because it targets the nervous system by blocking opioid receptors. Researchers are excited about naloxone's potential to address reproductive issues through this novel mechanism, which could offer relief for conditions that are not effectively managed by existing options. Naloxone is typically known for its use in reversing opioid overdoses, but its application here explores a new frontier, potentially offering a non-hormonal, non-invasive alternative for managing reproductive health.

What evidence suggests that naloxone might be an effective treatment for reproductive disorders?

Research has shown that naloxone effectively reverses opioid overdoses. While primarily used for this purpose, there is interest in its potential effects on reproductive health. Early studies suggest that naloxone's interaction with the body's opioid system could influence a hormone system involved in reproduction. However, limited data directly links naloxone to improvements in reproductive issues. This trial will explore naloxone's potential effects on reproductive health, with one group of participants receiving naloxone and another group undergoing blood sampling without medication. Understanding of naloxone's effects on reproduction is still developing, and further research is needed to confirm any possible benefits. ^{4 5 6 7 8}

Who Is on the Research Team?

Stephanie B. Seminara, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

Healthy individuals with normal puberty development, no chronic diseases or emergency medication reactions, not on prescriptions except for allergy meds, and not seeking fertility. Must have a BMI between 18.5-30, normal blood pressure and lab results within specific ranges. Men should have normal reproductive function; women need regular menstrual cycles and can't be pregnant or breastfeeding.

Inclusion Criteria

Normal hemoglobin

No excessive alcohol consumption (< 10 drinks/week)

Not currently seeking fertility

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo frequent blood sampling and administration of naloxone

12 hours per period

1 visit (in-person) per period

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• GnRH
• Naloxone

Trial Overview

The study is testing the impact of opioid antagonists like kisspeptin 112-121, GnRH, and Naloxone on the hormonal system that controls reproduction in healthy subjects to understand how these drugs affect hormone levels.

How Is the Trial Designed?

Group I: Arm 2 Experimental Treatment 1 Intervention

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.)

Group II: Arm 1 Active Control 1 Intervention

one period of frequent blood sampling with no medication administered

Naloxone is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Naloxone for:

• Opioid overdose reversal

Approved in European Union as Naloxone for:

• Opioid overdose reversal

Approved in Canada as Naloxone for:

• Opioid overdose reversal

Who Is Running the Clinical Trial?

Stephanie B. Seminara, MD

Lead Sponsor

Trials

10

Recruited

840+

Published Research Related to This Trial

Extended-release naltrexone (XR-NTX) is viewed positively by patients for its once-monthly dosing and lack of physical dependence, but barriers such as ambivalence and unfamiliarity with antagonist treatment hinder initiation, especially in the context of opioid detoxification.

Once patients initiate XR-NTX, they report it as an effective treatment for opioid use disorder (OUD), with high satisfaction and sustained abstinence, indicating its potential as a viable long-term solution for managing OUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' perspectives on initiating treatment with extended-release naltrexone (XR-NTX). Gauthier, P., Greco, P., Meyers-Ohki, S., et al.[2022]

Buprenorphine is a safe and effective treatment for opioid dependence, particularly when combined with naloxone, which reduces its potential for abuse.

New regulations enable certified physicians to prescribe buprenorphine in their offices, significantly improving patient access to this important treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buprenorphine maintenance: a new treatment for opioid dependence. Collins, GB., McAllister, MS.[2019]

Buprenorphine-naloxone (Suboxone) was found to be safe and well tolerated for short-term opioid detoxification in a study involving 234 opioid-dependent patients across twelve community-based treatment programs.

The treatment showed high medication compliance (81% of doses ingested) and successful induction, with 90% of patients reaching the target dose within three days, indicating its efficacy and practicality in diverse settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bringing buprenorphine-naloxone detoxification to community treatment providers: the NIDA Clinical Trials Network field experience. Amass, L., Ling, W., Freese, TE., et al.[2022]

Two case studies of pregnant patients with opioid use disorder (OUD) who switched from sublingual buprenorphine to monthly injections of Sublocade® showed no adverse outcomes for either the mothers or their babies, suggesting potential safety in this treatment during pregnancy.

Both patients maintained positive urine drug screens for buprenorphine throughout their pregnancies without experiencing withdrawal symptoms or birth anomalies, indicating that Sublocade may be a viable option for managing OUD in pregnant women, although further research is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subcutaneous Extended-Release Buprenorphine Use in Pregnancy. Towers, CV., Deisher, H.[2022]

Buprenorphine is as effective as methadone for opiate detoxification and maintenance but is safer in overdose situations, making it a preferable option for treatment.

Suboxone, a combination of buprenorphine and naloxone, is recommended for maintenance treatment due to its lower abuse potential, while Subutex (buprenorphine alone) is advised for pregnant women, highlighting the tailored approach to treatment based on patient needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buprenorphine in the treatment of opiate dependence. Wesson, DR., Smith, DE.[2013]

Citations

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papers.ssrn.com

papers.ssrn.com/sol3/Delivery.cfm/54836d92-d5cb-4fbe-b438-f2b66f56985c-MECA.pdf?abstractid=5589316&mirid=1

From Overdose Prevention to Reproductive Health

Results show no significant effects before Narcan (Panel A), but all four outcomes are significant after 2015 ... effectiveness of naloxone access laws in the ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8058255/

Association of Patient Sex and Pregnancy Status With ...

Pregnant women had strikingly lower odds of receiving naloxone and higher odds of admission compared to non-pregnant reproductive-aged women. We further ...

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fda.gov

fda.gov/media/189037/download?attachment

Naloxone Hydrochloride

There are no clinical efficacy data submitted in support of the proposed product to help assess its efficacy in treating overdoses. The ...

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recoveryanswers.org

recoveryanswers.org/research-post/feasibility-hospital-based-naloxone-education-distribution-program-for-postpartum-patients/

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This study examined the feasibility of a novel hospital-based program aimed at educating birthing-unit staff about harm reduction and providing naloxone to all ...

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bmcpublichealth.biomedcentral.com

bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-025-22210-8

Effectiveness of naloxone distribution in community settings to ...

The paper demonstrates that in the face of increasing overdose deaths over time, survival after naloxone administration has been sustained. The ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11537837/

Naloxone Use During Pregnancy – Data from 26 U.S. ...

Prevalence of naloxone use among people with an increased risk of overdose during pregnancy ranged from 5.0% to 17.6%.

7.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2021/212045s000lbl.pdf

KLOXXADO (naloxone hydrochloride) nasal spray

Available data from retrospective cohort studies on naloxone use in pregnant women have not identified a drug-associated risk of major birth defects, ...

8.

jamanetwork.com

jamanetwork.com/journals/jama/fullarticle/2822178

Safety of In Utero Exposure to Buprenorphine + Naloxone ...

For the outcomes assessed, compared with buprenorphine alone, buprenorphine with naloxone during pregnancy appears to be a safe treatment option ...