Endocannabinoids, Stress, Craving And Pain Effects Study

Opioid Use Disorder Clinical Trial

— ESCAPE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05480072
• Other study ID #: 2022P001440
• Status: Recruiting
• Phase: Early Phase 1
• Start date: November 1, 2022
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: December 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age 18 to 65

• DSM-5 diagnosis of OUD

• English speaking

• Receiving either buprenorphine or methadone for treatment of opioid use disorder for at least 3 consecutive months prior to enrollment

• Receiving a stable dose of buprenorphine or methadone for the duration of the study

• Agreeable to abstaining from using any cannabis or CBD products two weeks prior to enrollment in the study, and 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:

• DSM-5 diagnosis of moderate-to-severe cannabis use disorder, alcohol use disorder, and/or psychostimulant use disorder [medical record review and health history form]

• Active, recurrent substance use within the last 3 months that will interfere with study participation and completion of study procedures [medical record review and health history form]

• History of psychotic, bipolar and schizoaffective disorders [medical record review and health history form]

• Lifetime psychiatric hospitalization or suicide attempt, as assessed by the health history form

• Recent history (within 2 years) of major depressive disorder [health history form and clinical interview]

• Currently pregnant or breastfeeding (female only) [pregnancy test/ self-reported]

• History of autoimmune or chronic inflammatory diseases [health history form] Current use of medications known to alter inflammatory and immune response [health history form] Raynaud's disease [health history form]

• BMI >45

• Hepatic liver enzymes greater than 3x upper normal limit

• Vital signs: HR =60 or =100, SBP =90 or =160, DBP =50 or =100, RR < 12 or > 20

• Recent history of clinically significant medical conditions including, but not limited to, malignancy (and treatment for malignancy), HIV, immunological, endocrine (including uncontrolled diabetes or thyroid disease), renal, GI, or hematological abnormalities that are uncontrolled* [health history form and medical record review]

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders

Intervention

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

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	stress-induced opioid craving visual analog scale (VAS)	decrease from baseline in experimentally-provoked stress-induced craving ratings as measured via the visual analog scale (0= no craving to 100= extremely strong craving). Lower scores indicate reduced craving	day 21