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Endocannabinoid Modulator

Palmitoylethanolamide for Opioid Use Disorder (ESCAPE Trial)

Phase < 1
Recruiting
Research Sponsored by Brigham and Women's Hospital
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 day 21

Summary

This trial will investigate whether the dietary supplement palmitoylethanolamide (PEA) can help reduce craving and prevent relapse in patients with opioid use disorder.

Who is the study for?
The ESCAPE study is for individuals with Opioid Use Disorder who have been on buprenorphine or methadone treatment for at least 3 months. Participants must not use cannabis/CBD products during the trial, be fluent in English, and women must agree to use contraception or practice abstinence.
What is being tested?
This study tests if Palmitoylethanolamide (PEA), a dietary supplement affecting the endocannabinoid system, can reduce opioid craving and prevent relapse by targeting stress response, mood disturbances, and pain sensitivity.
What are the potential side effects?
While PEA is generally considered safe with minimal side effects due to its presence naturally in the body, potential side effects may include stomach discomfort or mild nausea.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 21
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 21 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
stress-induced opioid craving visual analog scale (VAS)

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: PEA 600 mgActive Control1 Intervention
PEA capsules (600 mg twice a day) will be administered for 21 days
Group II: PlaceboPlacebo Group1 Intervention
Placebo capsules (600 mg twice a day) will be administered for 21 days

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,666 Previous Clinical Trials
11,841,608 Total Patients Enrolled

Media Library

Palmitoylethanolamide (Endocannabinoid Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT05480072 — Phase < 1
Opioid Use Disorder Research Study Groups: PEA 600 mg, Placebo
Opioid Use Disorder Clinical Trial 2023: Palmitoylethanolamide Highlights & Side Effects. Trial Name: NCT05480072 — Phase < 1
Palmitoylethanolamide (Endocannabinoid Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05480072 — Phase < 1
~5 spots leftby Nov 2025
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