CompletedEarly Phase 1

Endocannabinoids, Stress, Craving And Pain Effects Study

United States12 participantsStarted 2022-11-01

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 \[health history form and clinical interview\] * C…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

stress-induced opioid craving visual analog scale (VAS)

Timeframe: day 21

Trial details

NCT IDNCT05480072

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-14

View on ClinicalTrials.gov More Opioid Use Disorder trials