Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Early Phase 1 study of Pain, sponsored by Yale University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Pain threshold and pain tolerance, in seconds.
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 |
What NCT04025359 shows while recruiting
NCT04025359 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 304-participant average among 374 other Pain trials with a reported enrollment target (88% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04025359's enrollment target sits among peer trials
36 296th of 374 higher than 77 of 374 other Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain 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
-
Opioid-Sparing and Pain-Reducing Properties of Syntocinon: A Dose-Effect Determination
RECRUITING · Early Phase 1
-
The Potential of Oxytocin to Reduce Opioid Abuse Liability and Pain Among Older Adults
RECRUITING · Early Phase 1
-
Remimazolam NeuroImaging
RECRUITING · Early Phase 1
-
Nitrous Oxide Neuroimaging
RECRUITING · Early Phase 1
-
Ketamine and Propofol NeuroImaging
RECRUITING · Early Phase 1
-
An English/Spanish Mobile Augmented Reality Pain Assessment App for Hispanic/Latino Pediatric Cancer Patients
ACTIVE NOT RECRUITING · Early Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00929006 · 36 participants · Early Phase 1
Acute Progesterone Suppression of Wake vs. Sleep Luteinizing Hormone Pulse Frequency in Pubertal Girls With and Without Hyperandrogenism
- NCT01891318 · 36 participants · Phase 1
Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study
- NCT02291848 · 36 participants · Phase 1
Tumor-Associated Antigen-Specific Cytotoxic T-Lymphocytes for Multiple Myeloma
- NCT02366819 · 36 participants · Phase 4
Genetic Analysis-Guided Irinotecan Hydrochloride Dosing of mFOLFIRINOX in Treating Patients With Locally Advanced Gastroesophageal or Stomach Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI