COMPLETED

Endocannabinoids, Stress, Craving And Pain Effects Study

Conditions

Opioid Use Disorder palmitoylethanolamide stress craving pain

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-11-01

Study Completion:2025-01-14

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05480072

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)	* 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\* \[health history form and medical record review\]

Inclusion Criteria

Exclusion 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)

* 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\* \[health history form and medical record review\]

Contacts and Locations

Study Locations (Sites)

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-01

Study Completion Date2025-01-14

Study Record Updates

Study Start Date2022-11-01

Study Completion Date2025-01-14

Terms related to this study

Keywords Provided by Researchers

palmitoylethanolamide
stress
craving
pain

Additional Relevant MeSH Terms

Opioid Use Disorder