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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 is a Early Phase 1 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 12 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05480072
The ClinicalTrials.gov registry entry for NCT05480072 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05480072 reports 0 study locations.
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.
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