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

Sponsor

Brigham and Women's Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05480072

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Opioid Use Disorder	Drug: Palmitoylethanolamide Other: Placebo	Early Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Investigating the Effects of Palmitoylethanolamide (PEA) on Stress, Craving and Pain in Opioid Use Disorder

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: PEA 600 mg PEA capsules(600 mg twice a day) will be administered for 21 days	Drug: Palmitoylethanolamide 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 Other Names: Levagen+
Placebo Comparator: Placebo Placebo capsules(600 mg twice a day) will be administered for 21 days	Other: Placebo Participants will receive placebo matched to 600 mg PEA (Levagen+) capsules BID orally from Day 1 to Day 21

Arm

Intervention/Treatment

Active Comparator: PEA 600 mg

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

Drug: Palmitoylethanolamide

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

Other Names:

Levagen+

Placebo Comparator: Placebo

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

Other: Placebo

Participants will receive placebo matched to 600 mg PEA (Levagen+) capsules BID orally from Day 1 to Day 21

Outcome Measures

Primary Outcome Measures

stress-induced opioid craving [day 21]
changes from baseline in experimentally-provoked stress-induced craving ratings

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

Brigham and Women's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Primavera A. Spagnolo, MD, PhD, Assistant Professor/ Research Scientist, Brigham and Women's Hospital

ClinicalTrials.gov Identifier:

NCT05480072

Other Study ID Numbers:

2022P001440

First Posted:

Jul 29, 2022

Last Update Posted:

Jul 29, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Primavera A. Spagnolo, MD, PhD, Assistant Professor/ Research Scientist, Brigham and Women's Hospital

palmitoylethanolamide

stress

craving

pain

Additional relevant MeSH terms:

Opioid-Related Disorders

Palmidrol

Study Results

No Results Posted as of Jul 29, 2022