Amitriptyline for Thermal Burns

PT
Overseen ByPharmacology Translational Unit
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a single 75mg dose of amitriptyline (an antidepressant) can block microvesicle particles (MVP) released from the skin after a small burn. It involves two groups: one takes amitriptyline first, then a placebo; the other takes a placebo first, then amitriptyline. The study targets adults who are generally healthy and not on medications that might interfere with amitriptyline. Participants should not have a history of poor wound healing or heart issues and must not have large tattoos in the testing areas. As a Phase 1 trial, the research focuses on understanding how the treatment works in people.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Previous research has studied amitriptyline for its safety in treating various conditions. Although limited data exists on using amitriptyline specifically for burns, the FDA has approved it for other uses, such as treating depression, indicating it is generally safe when used correctly.

One study found that small amounts of amitriptyline on wounds did not harm the healing process. However, another source noted that amitriptyline might reduce certain immune responses, which could be concerning for severe burns. This trial is in its early stages and aims to gather more information on its safety and tolerability.

Overall, while amitriptyline is usually considered safe for its approved uses, its effects on burn injuries remain under investigation. Participants should be aware of possible side effects and discuss any concerns with the trial team.12345

Why do researchers think this study treatment might be promising for burns?

Amitriptyline is unique because it offers a novel approach to treating thermal burns by potentially addressing pain management through a different mechanism. While standard treatments for thermal burns focus on wound care and pain relief using topical agents or opioids, amitriptyline works by modulating neurotransmitters in the brain to alleviate pain. This could provide an alternative for patients seeking non-opioid pain relief, potentially reducing reliance on habit-forming medications. Researchers are excited about its potential to enhance pain management in burn patients while minimizing side effects and addiction risks associated with traditional painkillers.

What evidence suggests that amitriptyline might be an effective treatment for thermal burns?

This trial will compare the effects of amitriptyline and a placebo on burn injuries. Research has shown that amitriptyline might aid recovery by reducing tiny particles released from the skin after a burn. These particles can be harmful, and decreasing their number might support recovery. Previous studies explored the impact of a single dose of amitriptyline on these particles, suggesting it might offer some protection. While further research is necessary, this represents a promising step toward helping people with minor burns.13678

Are You a Good Fit for This Trial?

This trial is for adults who have a very small, localized burn injury on their skin. People with certain health conditions or taking medications that could interfere with the study may not be able to participate.

Inclusion Criteria

I am between 18 and 60 years old.
Willing to participate and understand the informed consent document
Have reliable transportation
See 2 more

Exclusion Criteria

I am generally healthy and do not have heart rhythm problems or conflicting medications.
I have a history of blood pressure or heart problems.
I am currently taking medications that increase sun sensitivity or affect inflammation or mood.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of 75mg amitriptyline or placebo, followed by a localized thermal burn injury and skin biopsy

1 day per visit
2 visits (in-person)

Crossover Treatment

Participants switch treatments (amitriptyline or placebo) and repeat the procedure on the opposite forearm

6-10 weeks after initial treatment
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Amitriptyline

Trial Overview

The study is testing whether a single dose of amitriptyline (75mg) can reduce specific particles released from the skin after a minor burn, compared to a placebo. Participants are randomly assigned to receive either amitriptyline or placebo.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Placebo then AmitriptylineExperimental Treatment2 Interventions
Group II: Amitriptyline then PlaceboExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wright State University

Lead Sponsor

Trials
47
Recruited
55,300+

Citations

Pilot Studies Testing the Use of Oral Amitriptyline in Reducing ...

In fact, there is evidence suggesting that these MVP cause severe toxic effects and could be responsible for deaths following extensive thermal ...

Amitriptyline for Thermal Burns · Info for Participants

The study is testing whether a single dose of amitriptyline (75mg) can reduce specific particles released from the skin after a minor burn, compared to a ...

Acute and Chronic Thermal Burn Evaluation and Management

This activity reviews the basic approaches to burn care, underlying pathophysiology of thermal injuries and highlights the role of the interprofessional team.

Burn injury - PMC - NIH

Tissue injury following severe burns results in release of endogenous damage-associated molecular patterns (DAMPs) such as mitochondrial DNA and double-stranded ...

Severity of thermal burn injury is associated with systemic ...

promote secondary tissue damage. Our data revealed that 3rd degree burns showed higher CitH3 and NE levels and these results are in line.

AMITRIPTYLINE USAGE EXACERBATES THE IMMUNE ...

Both amitriptylinetreatment and burn injury resulted in a 40% decrease of leukocyte Asm activity. Following scald injury, we demonstrate increased reduction of ...

Burn Incidence & Treatments in the U.S. Fact Sheet

Explore national and state burn data with ABA's fact sheet. See trends, prevention insights, and care outcomes for better understanding and planning.

Thermal Burns: Overview, Pathophysiology, Quantifying ...

Burns are estimated to cause approximately 180,000 deaths annually worldwide, smoke detectors has significantly reduced the severity of burn ...