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NCT04025359 · ClinicalTrials.gov registry record · Early Phase 1
Effects of Dronabinol in Opioid Maintained Patients
A Early Phase 1 study of Pain, sponsored by Yale University.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT04025359 is a Early Phase 1 study of Pain that is actively recruiting participants, run by Yale University. The registered enrollment target is 36 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04025359, a Early Phase 1 study of Pain, is actively recruiting participants, sponsored by Yale University.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
Twenty male and female (ages 18-70) participants with OUD currently receiving methadone or buprenorphine will be enrolled. Prior to their daily methadone or buprenorphine dose and thus at trough plasma levels of opioid, participants will receive dronabinol (2.5 mg, 5mg) or placebo. Subsequently, all participants will undergo laboratory testing of opioid-related outcomes. Pain sensitivity will be measured using a technique called the (QST) quantitative sensory testing, which involves the administering heat or cold stimulation. A Short-Form McGill Pain Questionnaire (SF-MPQ) and a pain Visual Analog Scale (VAS). Attentional bias will be measured using a visual probe task. Negative affect will be measured using the Positive and Negative Affect Schedule (PANAS). Cognitive performance will be measured by a comprehensive cognitive battery. The order of study medication administration will be counterbalanced order to minimize carryover effects. On the initial screening day and at the end of medication treatment, blood will be drawn to determine serum cytokine levels. One week after the last study medication dose, a follow-up session will be conducted during which participants will undergo urine toxicology testing and a safety evaluation before final discharge from the study.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Dronabinol
Study Locations (1)
Connecticut
- VA Connecticut Healthcare System - West Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2019-05-31 |
| Est. Completion | 2026-09-01 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04025359
The ClinicalTrials.gov registry entry for NCT04025359 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 304-participant average among 374 other Pain trials with a reported enrollment target (88% lower). The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Pain appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04025359 reports 1 study location spanning 1 distinct geographic area - top geographies include Connecticut.
Frequently Asked Questions
What is clinical trial NCT04025359 about?
NCT04025359 is a clinical study titled "Effects of Dronabinol in Opioid Maintained Patients". Twenty male and female (ages 18-70) participants with OUD currently receiving methadone or buprenorphine will be enrolled. Prior to their daily methadone or buprenorphine dose and thus at trough plasma levels of opioid, participants will receive dronabinol (2.5 mg, 5mg) or placebo. Subsequently, all...
What is the current status of trial NCT04025359?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 36 participants. The study started on 2019-05-31. Estimated completion is 2026-09-01.
What conditions does trial NCT04025359 study?
This clinical trial studies the following conditions: Pain.
What interventions are being tested in trial NCT04025359?
The interventions under investigation include: Placebo (DRUG), Dronabinol (DRUG).
Who is sponsoring clinical trial NCT04025359?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04025359 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.