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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up two days

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Neural responses

Secondary outcome measures

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor

688 Previous Clinical Trials

374,474 Total Patients Enrolled

9 Trials studying Pain

1,817 Patients Enrolled for Pain

Luana Colloca, MD/PhD/MSPrincipal InvestigatorUniversity of Maryland Baltimore School of Nursing

1 Previous Clinical Trials

259 Total Patients Enrolled

1 Trials studying Pain

259 Patients Enrolled for Pain

Media Library

Naloxone (Opioid Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT03897998 — Phase 2

Pain Research Study Groups: Naloxone, Saline

Pain Clinical Trial 2023: Naloxone Highlights & Side Effects. Trial Name: NCT03897998 — Phase 2

Naloxone (Opioid Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03897998 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Would elderly patients be eligible for this type of research?

"The age range for patients that are eligible for this trial is 18-55."

Answered by AI

Why is Naloxone given to patients?

"Naloxone is not only useful for treating opioid overdoses, but can also mitigate pain, pruritus, and septic shock."

Answered by AI

Who meets the requirements to join this clinical trial?

"This study is looking for 182 individuals aged 18-55 who suffer from pain and meet the additional requirements of being an English speaker (both written and spoken)."

Answered by AI

Are researchers still recruiting patients for this study?

"That is correct. The online clinicaltrials.gov database shows that this study, which was originally posted on November 1st 2021, is still recruiting patients. One hundred and eighty-two people are needed for the trial taking place at a single site."

Answered by AI

Could you please explain the possible side effects of Naloxone?

"Naloxone is assessed to be a 2 in terms of safety. This medication is currently in Phase 2 clinical trials, which means that while there are some data supporting its safety, none support efficacy as of yet."

Answered by AI

Are there other examples in the medical literature of Naloxone being used in a clinical trial?

"There are currently 41 ongoing trials involving Naloxone, 10 of which are in the third stage. Although a large portion of these studies originate from Durham, North carolina, there are a total of 126 sites running these trials."

Answered by AI

How many participants are being recruited for this trial?

"That is correct, the trial detailed on clinicaltrials.gov is still recruiting patients. This specific study was posted on November 1st 2021 and updated most recently on May 27th 2022. They are currently enrolling 182 people across 1 location."

Answered by AI

Recent research and studies

PainJournal

Observe to Get Pain Relief: Current Evidence and Potential Mechanisms of Socially Learned Pain Modulation

Schenk, Lieven A., Samuel R. Krimmel, and Luana Colloca. 2017. “Observe to Get Pain Relief: Current Evidence and Potential Mechanisms of Socially Learned Pain Modulation”. Pain. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/j.pain.0000000000000943.

Journal of NeuroscienceJournal

Opioid-mediated Placebo Responses Boost Pain Endurance and Physical Performance: Is It Doping in Sport Competitions?

Benedetti, F., A. Pollo, and L. Colloca. 2007. “Opioid-mediated Placebo Responses Boost Pain Endurance and Physical Performance: Is It Doping in Sport Competitions?”. Journal of Neuroscience. Society for Neuroscience. doi:10.1523/jneurosci.3330-07.2007.

Annual Review of Pharmacology and ToxicologyJournal

The Placebo Effect in Pain Therapies

Colloca, Luana. 2019. “The Placebo Effect in Pain Therapies”. Annual Review of Pharmacology and Toxicology. Annual Reviews. doi:10.1146/annurev-pharmtox-010818-021542.

clinicaltrials.govStudy