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Opioid Antagonist

Observational Analgesia Mechanisms for Pain Management

Phase 2

Recruiting

Led By Luana Colloca, MD/PhD/MS

Research Sponsored by University of Maryland, Baltimore

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age (18-55 years old)

English speaker (written and spoken)

Must not have

Any prior eye injury or the potential of a foreign body in the eye (e.g., worked in metal fields)

Chronic intranasal drug use ( e.g., intranasal decongestants; antihistamines)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up two days

Summary

This trial is designed to study how the brain responds to observing another person in pain, in order to determine the brain mechanisms of observationally-induced analgesia.

Who is the study for?

This trial is for English-speaking adults aged 18-55 without chronic pain, severe psychiatric conditions, or recent hospitalization for mental health issues. Participants must not be pregnant, color-blind, left-handed, have metal implants incompatible with MRI scans, a history of substance abuse or use certain medications recently.

What is being tested?

The study investigates how observing others influences our brain's response to pain. It uses saline and naloxone alongside brain imaging techniques like fMRI and EEG to understand the neurobiological activation that leads to reduced pain perception through observation.

What are the potential side effects?

While specific side effects are not listed for this observational study involving saline (a harmless saltwater solution) and naloxone (an opioid antagonist), typical risks may include discomfort at injection site or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 55 years old.

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I can speak and write in English.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had an eye injury or might have metal in my eye from work.

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I regularly use nasal sprays for conditions like allergies.

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I have not been hospitalized or treated for severe mental health issues in the last 3 years.

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I have a history of chronic pain or am currently experiencing pain.

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I have used prescribed medication for depression, ADHD, pain, or certain sedatives in the last 3 months.

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I have lasting difficulties from a head injury.

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I have nasal polyps.

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I have hearing problems that haven't been corrected.

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I do not have major health issues like heart, lung, kidney, liver diseases, or cancer in the last 3 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ two days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~two days

This trial's timeline: 3 weeks for screening, Varies for treatment, and two days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Neural responses

Secondary study objectives

Pain

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: NaloxoneActive Control1 Intervention

NARCAN® Naloxone Nasal Spray will be used to block placebo effects during the fMRI experiment. Participants will be stratified for sex and then randomized to naloxone (The dose of naloxone will be 4 mg, so 0.1 mL of 40 mg/ml naloxone solution given intranasally) or saline (0.1 mL 0.9% sodium chloride intranasally), respectively. Investigators, staff, and participants will be blinded to the treatment options.

Group II: SalinePlacebo Group1 Intervention

Saline will be used as a sham comparator for blocking placebo effects during the fMRI experiment. Participants will be stratified for sex and then randomized to naloxone (The dose of naloxone will be 4 mg, so 0.1 mL of 40 mg/ml naloxone solution given intranasally) or saline (0.1 mL 0.9% sodium chloride intranasally), respectively. Investigators, staff, and participants will be blinded to the treatment options.

0 / 11Eligibility criteria met