Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04587791 · ClinicalTrials.gov registry record · Early Phase 1
Cannabidiol in Opioid Use Disorder and Chronic Pain
A Early Phase 1 study of Chronic Pain and Opioid Use Disorder, sponsored by Yale University.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 34
- Enrollment target
- 1
- Study location
NCT04587791: Recruiting Early Phase 1 study of Chronic Pain and Opioid Use Disorder, sponsored by Yale University.
NCT04587791 is a Early Phase 1 study of Chronic Pain and Opioid Use Disorder that is actively recruiting participants, run by Yale University. The registered enrollment target is 34 participants, below the 772-participant average among 301 other Chronic Pain trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04587791, a Early Phase 1 study of Chronic Pain and Opioid Use Disorder, is actively recruiting participants, sponsored by Yale University.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 34 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a randomized, placebo-controlled, crossover human laboratory study investigating the dose-dependent safety and acute effects of Cannabidiol (CBD) on measures of pain and opioid craving in outpatients with opioid use disorder (OUD) receiving medication-assisted treatment with methadone or buprenorphine. With a duration of approximately 4 weeks, participants will come to the testing site for a total of five times: one initial screening session, and four experimental sessions where study medication, CBD, will be administered, separated by at least 72 hours to limit carryover effects.
Primary Outcome
The SAFTEE is a multi-symptom checklist that has been used successfully in the investigators previous studies to assess and monitor any adverse events and possible side effects of study medications. It includes information regarding the severity of any presenting symptoms (0= none, 1= mild, 2= moderate, and 3= severe), as well as the course of action taken by the study staff in response. The SAFTEE is administered before the administration of CBD at baseline, (timepoint -30 minutes) and 4 hours
Conditions Studied
Interventions
- DRUG Saline
- DRUG 400 mg Cannabidiol
- DRUG 800 mg Cannabidiol
- DRUG 1200 mg Cannabidiol
Study Locations (1)
Connecticut
- Department of Veterans Affairs Hospital - West Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2021-12-08 |
| Est. Completion | 2026-08-31 |
| Phase | Early Phase 1 |
What NCT04587791 shows while recruiting
NCT04587791 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 772-participant average among 301 other Chronic Pain trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Chronic Pain appearing as the primary indexed condition, and to 4 interventions - of which Saline is the first listed.
NCT04587791 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT04587791 about?
NCT04587791 is a clinical study titled "Cannabidiol in Opioid Use Disorder and Chronic Pain". This is a randomized, placebo-controlled, crossover human laboratory study investigating the dose-dependent safety and acute effects of Cannabidiol (CBD) on measures of pain and opioid craving in outpatients with opioid use disorder (OUD) receiving medication-assisted treatment with methadone or bup...
What is the current status of trial NCT04587791?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 34 participants. The study started on 2021-12-08. Estimated completion is 2026-08-31.
What conditions does trial NCT04587791 study?
This clinical trial studies the following conditions: Chronic Pain, Opioid Use Disorder.
What interventions are being tested in trial NCT04587791?
The interventions under investigation include: Saline (DRUG), 400 mg Cannabidiol (DRUG), 800 mg Cannabidiol (DRUG), 1200 mg Cannabidiol (DRUG).
Who is sponsoring clinical trial NCT04587791?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04587791 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 Chronic 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 NCT04587791's enrollment target sits among peer trials
34 235th of 301 higher than 63 of 301 other Chronic Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic 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
-
Safety and Efficacy of Mesenchymal Stem Cells Associated With Chronic Pancreatitis Pain
RECRUITING · Early Phase 1
-
Improving Pain Management Via Spinal Cord Stimulation and Blood Pressure Reduction
ACTIVE NOT RECRUITING · Early Phase 1
-
Immunologic Response to Negative Cognition in Persons With Chronic Pain
COMPLETED · Early Phase 1
-
Managing Chronic Pain in Veterans With Substance Use Disorders
COMPLETED · Early Phase 1
-
Non-Opioid Pramipexole and Pain
COMPLETED · Early Phase 1
-
Exploratory Evaluation of [11C]-NOP46
COMPLETED · 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
- NCT02897063 · 34 participants · Phase 1
Effects of Midodrine and Droxidopa on Splanchnic Capacitance in Autonomic Failure
- NCT03906617 · 34 participants · Phase 4
Bupivacaine/Epinephrine +Dexamethasone vs. Liposomal Bupivacaine
- NCT03992378 · 34 participants · NA
Neuromodulation to Regulate Inflammation and Autonomic Imbalance in Sepsis
- NCT04047849 · 34 participants · Phase 4
Latency Antibiotics in Previable PPROM, 18 0/7- 22 6/7 WGA
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