Trial reportJournal of addiction medicine
Safety and pharmacokinetics of oral cannabidiol when administered concomitantly with intravenous fentanyl in humans.
Trial report in Journal of addiction medicine. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05969314 (Phase I Study of Safety and Feasibility of Ayurvedic Oral Cannabis Preparation in the Peri-operative Period in Breast and Oral Cavity Squamous Cell Cancer), which is not on this map. Cited by 63 papers, 6 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Phase I Study of Safety and Feasibility of Ayurvedic Oral Cannabis Preparation in the Peri-operative Period in Breast and Oral Cavity Squamous Cell Cancer
Who cites it
63 citing papers in PubMed, 6 syntheses or guidelines pooled it, 124 citations in OpenAlex.
- The Potential Use of Cannabidiol in the Treatment of Opioid Use Disorder: A Systematic Review.Addiction biology · 2025Pooled it
- Quantitative summary on the human pharmacokinetic properties of cannabidiol to accelerate scientific clinical application of cannabis.Naunyn-Schmiedeberg's archives of pharmacology · 2024Pooled it
- Evaluation of potential drug-drug interactions with medical cannabis.Clinical and translational science · 2024Pooled it
- Systematic review of drug-drug interactions of delta-9-tetrahydrocannabinol, cannabidiol, andFrontiers in pharmacology · 2024Pooled it
- The Effectiveness and Safety of Cannabidiol in Non-seizure-related Indications: A Systematic Review of Published Randomized Clinical Trials.Pharmaceutical medicine · 2022Pooled it
- Food effects on the formulation, dosing, and administration of cannabidiol (CBD) in humans: A systematic review of clinical studies.Pharmacotherapy · 2021Pooled it
- Cannabidiol attenuates precuneus activation during appetitive cue exposure in individuals with alcohol use disorder.European archives of psychiatry and clinical neuroscience · 2025Trial
- Pilot Study of Cannabidiol for Treatment of Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Breast Cancer.Cancer medicine · 2025Trial
- The effects of cannabidiol on subjective states, cognition, and psychomotor function in healthy adults: A randomized clinical trial.Fundamental & clinical pharmacology · 2023Trial
- Article
- Cannabidiol and neural correlates of threat anticipation in alcohol use disorder.Psychopharmacology · 2026Article
- Dose- and tissue-dependent effects of cannabidiol on antioxidant status in developing chicken embryos.Scientific reports · 2025Article
- Article
- An Overview of the Potential for Pharmacokinetic Interactions Between Drugs and Cannabis Products in Humans.Pharmaceutics · 2025Review
- Proof of concept for high-dose Cannabidiol pretreatment to antagonize opioid induced persistent apnea in mice.Frontiers in neuroscience · 2025Article
- Cannabinoids for Acute Pain Management: Approaches and Rationale.Current pain and headache reports · 2024Review
- CBD and THC in Special Populations: Pharmacokinetics and Drug-Drug Interactions.Pharmaceutics · 2024Review
- Cannabinoid-Induced Inhibition of Morphine Glucuronidation and the Potential for In Vivo Drug-Drug Interactions.Pharmaceutics · 2024Article
- Strategies to Improve Cannabidiol Bioavailability and Drug Delivery.Pharmaceuticals (Basel, Switzerland) · 2024Review
- Efficacy of cannabinoids compared to the current standard treatments on symptom relief in persons with multiple sclerosis (CANSEP trial): study protocol for a randomized clinical trial.Frontiers in neurology · 2024Article
3 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 1 institution in 1 country.
Funding
Abstract
objectivesCannabidiol (CBD) is hypothesized as a potential treatment for opioid addiction, with safety studies an important first step for medication development. We determined CBD safety and pharmacokinetics when administered concomitantly with a high-potency opioid in healthy subjects.
methodsThis double-blind, placebo-controlled cross-over study of CBD, coadministered with intravenous fentanyl, was conducted at the Clinical Research Center in Mount Sinai Hospital, a tertiary care medical center in New York City. Participants were healthy volunteers aged 21 to 65 years with prior opioid exposure, regardless of the route. Blood samples were obtained before and after 400 or 800 mg of CBD pretreatment, followed by a single 0.5 (session 1) or 1.0 μg/kg (session 2) of intravenous fentanyl dose. The primary outcome was the Systematic Assessment for Treatment Emergent Events (SAFTEE) to assess safety and adverse effects. CBD peak plasma concentrations, time to reach peak plasma concentrations (tmax), and area under the curve (AUC) were measured.
resultsSAFTEE data were similar between groups without respiratory depression or cardiovascular complications during any test session. After low-dose CBD, tmax occurred at 3 and 1.5 hours in sessions 1 and 2, respectively. After high-dose CBD, tmax occurred at 3 and 4 hours in sessions 1 and 2, respectively. There were no significant differences in plasma CBD or cortisol (AUC P = NS) between sessions.
conclusionsCannabidiol does not exacerbate adverse effects associated with intravenous fentanyl administration. Coadministration of CBD and opioids was safe and well tolerated. These data provide the foundation for future studies examining CBD as a potential treatment for opioid abuse.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.