search
Back to results

Endocannabinoids, Stress, Craving And Pain Effects (ESCAPE) Study

Primary Purpose

Opioid Use Disorder

Status
Not yet recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Palmitoylethanolamide
Placebo
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Use Disorder focused on measuring palmitoylethanolamide, stress, craving, pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of OUD
  • Fluent in English
  • Receiving either buprenorphine or methadone for treatment of opioid use disorder for at least 3 consecutive months prior to enrollment
  • Agreeable to abstaining from using any cannabis or cannabidiol (CBD)-containing products for the duration of the trial

  • For women of childbearing potential: agreeable to use one of the following:

    • hormonal methods, such as birth control pills, patches, injections, vaginal rings, or implants
    • barrier methods (such as a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm)
    • intrauterine device (IUD)
    • abstinence (no sex)

Exclusion Criteria:

  • Current diagnosis of moderate-to-severe cannabis use disorder and/or alcohol use disorder
  • History of psychotic and schizoaffective disorders
  • Currently pregnant or breastfeeding (female only)
  • History of autoimmune or chronic inflammatory diseases
  • Current use of medications known to alter inflammatory and immune response
  • BMI >40

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

PEA 600 mg

Placebo

Arm Description

PEA capsules(600 mg twice a day) will be administered for 21 days

Placebo capsules(600 mg twice a day) will be administered for 21 days

Outcomes

Primary Outcome Measures

stress-induced opioid craving
changes from baseline in experimentally-provoked stress-induced craving ratings

Secondary Outcome Measures

Full Information

First Posted
July 27, 2022
Last Updated
July 27, 2022
Sponsor
Brigham and Women's Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05480072
Brief Title
Endocannabinoids, Stress, Craving And Pain Effects (ESCAPE) Study
Official Title
Investigating the Effects of Palmitoylethanolamide (PEA) on Stress, Craving and Pain in Opioid Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2022 (Anticipated)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Opioid use disorder (OUD) represents one of the most severe public health crises, with more than 2 million individuals affected in the United States. Existing treatments do not target and restore several key alterations triggering opioid craving and relapse, including increased response to stress, mood disturbances and greater sensitivity to pain, which are caused by prolonged exposure to opioids. This double-blind, randomized, placebo-controlled study will investigate the effects that palmitoylethanolamide (PEA), an endogenous molecule part of the endocannabinoid system available as a dietary supplement, exerts on these alterations and their underlying mechanisms, with the goal of identifying a novel therapeutic approach to reduce craving and prevent relapse in patients with OUD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use Disorder
Keywords
palmitoylethanolamide, stress, craving, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PEA 600 mg
Arm Type
Active Comparator
Arm Description
PEA capsules(600 mg twice a day) will be administered for 21 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsules(600 mg twice a day) will be administered for 21 days
Intervention Type
Drug
Intervention Name(s)
Palmitoylethanolamide
Other Intervention Name(s)
Levagen+
Intervention Description
Palmitoyethanolamide (PEA) s a dietary supplement with anti-inflammatory and analgesic properties. Subjects will receive PEA (Levagen+) 600 capsules mg twice daily (BID) orally from Day 1 to Day 21
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Participants will receive placebo matched to 600 mg PEA (Levagen+) capsules BID orally from Day 1 to Day 21
Primary Outcome Measure Information:
Title
stress-induced opioid craving
Description
changes from baseline in experimentally-provoked stress-induced craving ratings
Time Frame
day 21

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of OUD Fluent in English Receiving either buprenorphine or methadone for treatment of opioid use disorder for at least 3 consecutive months prior to enrollment Agreeable to abstaining from using any cannabis or cannabidiol (CBD)-containing products for the duration of the trial For women of childbearing potential: agreeable to use one of the following: hormonal methods, such as birth control pills, patches, injections, vaginal rings, or implants barrier methods (such as a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm) intrauterine device (IUD) abstinence (no sex) Exclusion Criteria: Current diagnosis of moderate-to-severe cannabis use disorder and/or alcohol use disorder History of psychotic and schizoaffective disorders Currently pregnant or breastfeeding (female only) History of autoimmune or chronic inflammatory diseases Current use of medications known to alter inflammatory and immune response BMI >40
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ancella Roy
Phone
617-732-5935
Email
aroy19@bwh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Primavera A Spagnolo, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Endocannabinoids, Stress, Craving And Pain Effects (ESCAPE) Study

We'll reach out to this number within 24 hrs