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NCT05480072 · ClinicalTrials.gov registry record · Early Phase 1
Endocannabinoids, Stress, Craving And Pain Effects Study
A Early Phase 1 study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 12
- Enrollment target
NCT05480072: Completed Early Phase 1 study, sponsored by Brigham and Women's Hospital.
NCT05480072 is a Early Phase 1 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 12 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05480072, a Early Phase 1 study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 12 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- OTHER Placebo
- DRUG Palmitoylethanolamide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2022-11-01 |
| Est. Completion | 2025-01-14 |
| Phase | Early Phase 1 |
What the finished NCT05480072 record still lists
NCT05480072 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05480072 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05480072 about?
NCT05480072 is a clinical study titled "Endocannabinoids, Stress, Craving And Pain Effects Study". 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, m...
What is the current status of trial NCT05480072?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 12 participants. The study started on 2022-11-01. Estimated completion is 2025-01-14.
What interventions are being tested in trial NCT05480072?
The interventions under investigation include: Placebo (OTHER), Palmitoylethanolamide (DRUG).
Who is sponsoring clinical trial NCT05480072?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05480072's enrollment target sits among peer trials
12 1529th of 2000 higher than 401 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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