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Opioid Antagonist

Naltrexone for Chronic Pruritus

Phase 2
Waitlist Available
Led By Paul Bigliardi, MD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week
Awards & highlights

Study Summary

This trial will study the epigenetic mechanisms behind chronic itch and test the efficacy of opioid antagonists in atopic dermatitis.

Eligible Conditions
  • Chronic Pruritus
  • Atopic Dermatitis
  • Eczema
  • Itching

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Itch Intensity (Visual Analog Scale)

Side effects data

From 2011 Phase 4 trial • 165 Patients • NCT00006489
24%
Nausea
12%
Headache
12%
Cold
10%
Dry Mouth
10%
Fatigue
7%
Gastrointestinal Issues
7%
Muscle Aches
7%
Vomiting
7%
Serious Suicidal Ideation
5%
Constipation
5%
Diarrhea
5%
Stomach Virus
5%
Changes to Vision
5%
Loose Stool
5%
Increased Irritability
5%
Sedation
5%
Stomach Pain
5%
Increased Bowel Movements
2%
Toothache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Naltrexone + Supportive Counseling
Naltrexone + CBT (Prolonged Exposure Therapy)
Placebo + CBT (Prolonged Exposure Therapy)
Placebo + Supportive Counseling

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Cohort 1: Placebo, then InterventionExperimental Treatment2 Interventions
Patients will start with placebo in week 1 and cross over to Naltrexone in week 3. There will be a wash-out phase during week 2 using only moisturizer regularly and if necessary as rescue medications topical corticosteroids and/or antihistamines. The same rescue medications can be used during the following weeks of the cross-over treatment. At visit 2 and 4 patients will be asked the area where they are experiencing most intense itch and we will take there suction blisters (preferably on the trunk). Suction blisters will be taken after week 1 (1 week on treatment arm 1) and after week 3 (1 week on treatment arm 2).
Group II: Circadian Rhythm of ItchActive Control1 Intervention
Patients in this arm will receive no intervention, only data collection.
Group III: Cohort 2: Intevention, then PlaceboActive Control2 Interventions
Patients will start with Naltrexone in week 1 and cross over to the palcebo treatment in week 3. There will be a wash-out phase during week 2 using only moisturizer regularly and if necessary as rescue medications topical corticosteroids and/or antihistamines. The same rescue medications can be used during the following weeks of the cross-over treatment. At visit 2 and 4 patients will be asked the area where they are experiencing most intense itch and we will take there suction blisters (preferably on the trunk). Suction blisters will be taken after week 1 (1 week on treatment arm 1) and after week 3 (1 week on treatment arm 2).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Naltrexone
2005
Completed Phase 4
~2420

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,379 Previous Clinical Trials
1,588,492 Total Patients Enrolled
Paul Bigliardi, MDPrincipal InvestigatorUniversity of Minnesota
2 Previous Clinical Trials
8 Total Patients Enrolled

Frequently Asked Questions

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

To what extent has enrollment been achieved for this medical experiment?

"No, this trial is not currently enrolling. It was initially posted on December 31st 2022 and last updated on February 25th 2022. If you are searching for alternative studies, 262 medical trials related to dermatitis presently accept new participants and 46 clinicaltrials.gov postings look for volunteers taking Naltrexone."

Answered by AI

Are there any eligibility criteria that would preclude my involvement in this experiment?

"Prospective enrollees of this trial must have a clinical diagnosis of dermatitis and be between the ages 18 to 70. This research is currently accepting 56 participants."

Answered by AI

Does the eligibility criteria extend beyond 25 years of age for this research program?

"Qualified persons for this experiment must be aged between 18 and 70. There are 106 studies available to minors, while 222 have been developed specifically for elderly participants."

Answered by AI

What other research involving Naltrexone has been conducted to date?

"Currently, there are 46 ongoing clinical trials studying Naltrexone with 12 of them in their final stages. These trials span over 161 locations worldwide, with the majority located in New york City."

Answered by AI

What potential risks do patients face while taking Naltrexone?

"The safety of Naltrexone is rated a 2 as this Phase 2 trial has some evidence-based data to support its security, yet nothing in terms of efficacy."

Answered by AI

Are there any vacancies remaining in this experiment for volunteers?

"Unfortunately, this research is no longer accepting patient enrolment. It was originally listed on December 31st 2022 and last updated on February 25th 20212. If you are seeking alternative options, there are 262 trials involving dermatitis and 46 studies centred around Naltrexone that currently require participants."

Answered by AI

To what ailments is Naltrexone commonly prescribed?

"Naltrexone is typically employed to manage chronic weight but can also be utilized for other issues such as increased physical activity, pain management, and diminishing calorie intake."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Treatment of Chronic Itch in Atopic Dermatitis With Opioid Antagonist Naltrexone
2022. "Treatment of Chronic Itch in Atopic Dermatitis With Opioid Antagonist Naltrexone". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04325802.
~0 spots leftby Jun 2024
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