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Endocannabinoid Modulator

Palmitoylethanolamide for Opioid Use Disorder (ESCAPE Trial)

Q: Are there any vacancies left in this medical trial?

Clinicaltrials.gov reveals that this medical trial, which was initiated on August 1st 2022 and last modified on July 27th 2022, is no longer actively recruiting patients. However, there are presently 291 other studies requiring volunteers to participate in their research.

Q: Are there any characteristics that make certain individuals a better fit for enrollment in this research study?

This study has a limited number of spots available; 16 participants may participate. To be eligible, applicants must demonstrate an opioid use disorder (OUD) and meet the age criteria: between 18 to 65 years old.

Q: Is the upper age limit above 75 years of age for this clinical trial?

The terms of admission to this medical trial stipulate that subjects must be 18 years or older and no more than 65.

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

Awards & highlights

ESCAPE Trial 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.Check my eligibility

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.See study design

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.

ESCAPE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 21

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

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

Primary outcome measures

stress-induced opioid craving visual analog scale (VAS)

ESCAPE 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor

1,618 Previous Clinical Trials

11,471,365 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

Frequently Asked Questions

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

Are there any vacancies left in this medical trial?

"Clinicaltrials.gov reveals that this medical trial, which was initiated on August 1st 2022 and last modified on July 27th 2022, is no longer actively recruiting patients. However, there are presently 291 other studies requiring volunteers to participate in their research."

Answered by AI

Are there any characteristics that make certain individuals a better fit for enrollment in this research study?

"This study has a limited number of spots available; 16 participants may participate. To be eligible, applicants must demonstrate an opioid use disorder (OUD) and meet the age criteria: between 18 to 65 years old."

Answered by AI