Treatment of Chronic Itch in Atopic Dermatitis With Opioid Antagonist Naltrexone (NCT04325802) | Clinical Trial Compass
WithdrawnPhase 2
Treatment of Chronic Itch in Atopic Dermatitis With Opioid Antagonist Naltrexone
Stopped: Covid-19 pandemic
United States0Started 2022-12-31
Plain-language summary
Purpose: To study the etiology and the epigenetic pathways leading to and regulating chronic itch. Similarly, to examine the mechanisms underlying skin changes, including epigenetic alterations while also testing the efficacy of opioid antagonists in atopic dermatitis. In this study, the investigators aim to examine chronic sensory disorder mechanisms related to chronic itch.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of AD via simplified UK Working Group Criteria and a baseline PSGA score of 2 or greater
* Willingness to adhere to study protocol
* Subjects taking hormone-containing medications must be on a stable dose for 6 months prior to study start to avoid any confounding influence on sensory and pain perception
Exclusion Criteria:
* Use of topical or oral anti-inflammatory medications for 2 weeks prior to the study start.
* Use of topical or oral anti-histamines for 2 weeks prior to the study start (as rescue medication allowed).
* Use of topical or oral anti-pruritic agents for 2 weeks prior to the study start.
* Use of oral neuromodulatory agents for 2 months prior to study start.
* Current use of chronic pain medications (including opioids, antidepressants and anti-epileptic drugs).
* Use of nicotine-containing products for the past 6 months prior to study start.
* History of radiation or chemotherapy.
* History of traumatic injury on prospective test sites.
* Unstable thyroid function within the past 6 months prior to study start to exclude thyroid-related neuropathy
* Known history of central or peripheral nervous system dysfunction.
* History of acute hepatitis, chronic liver disease or end stage liver disease.
* History of human immunodeficiency virus (HIV) or acquired immune deficiency syndrome.
* History of neuropathy associated with chronic obstructive pulmonary disease, diabetes mellitus, documented exposure to organophosphates or heavy m…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.