Evidence map›Paper›PMID 33710277›Full record

Trial reportJournal of analytical toxicology2022

Safety, Pharmacokinetics and Pharmacodynamics of Spectrum Yellow Oil in Healthy Participants.

Erica N Peters, Irina Mosesova, Laura MacNair, Ryan Vandrey, M Hunter Land, Mark A Ware, Cynthia Turcotte, Marcel O Bonn-Miller

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of analytical toxicology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
2.7field-weighted citation impact, top 10% of its field
1 · What the graph read from 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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 23 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Review
  8. Article
  9. Article
  10. The Potential of Cannabichromene (CBC) as a Therapeutic Agent.The Journal of pharmacology and experimental therapeutics · 2024
    Review
  11. CBD Versus CBDP: Comparing In Vitro Receptor-Binding Activities.International journal of molecular sciences · 2024
    Article
  12. Article
  13. Article
  14. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 1 institution in 1 country.

Erica N PetersCanopy Growth Corporation, One Hershey Drive, Smiths Falls, ON K7A 0A8, Canada.ORCID 0000-0002-5563-9819
Irina MosesovaCanopy Growth Corporation, One Hershey Drive, Smiths Falls, ON K7A 0A8, Canada.
Laura MacNairCanopy Growth Corporation, One Hershey Drive, Smiths Falls, ON K7A 0A8, Canada.
Ryan VandreyJohns Hopkins University School of Medicine, 5510 Nathan Shock Drive, Baltimore, MD 21218, USA.
M Hunter LandCanopy Growth Corporation, One Hershey Drive, Smiths Falls, ON K7A 0A8, Canada.
Mark A WareCanopy Growth Corporation, One Hershey Drive, Smiths Falls, ON K7A 0A8, Canada.
Cynthia TurcotteCanopy Growth Corporation, One Hershey Drive, Smiths Falls, ON K7A 0A8, Canada.
Marcel O Bonn-MillerCanopy Growth Corporation, One Hershey Drive, Smiths Falls, ON K7A 0A8, Canada.
Johns Hopkins University · US

Funding

Canopy Growth Corporation
6 · The paper itself

Abstract

Due to a lack of published pharmacokinetic (PK) and/or pharmacodynamic (PD) data, decision-making surrounding appropriate dosing of cannabis used for medical purposes is limited. This multiple-dose study evaluated the safety, tolerability, PK and PD of Spectrum Yellow oil [20 mg/mL cannabidiol (CBD)/<1 mg/mL ∆9-tetrahydrocannabinol (THC)]. Participants (n = 43) were randomized to one of five groups: 120 mg CBD and 5.4 mg THC daily, 240 mg CBD and 10.8 mg THC daily, 360 mg CBD and 16.2 mg THC daily, 480 mg CBD and 21.6 mg THC daily or placebo. Study medication was administered every 12 h for 7 consecutive days. Treatment-emergent adverse events (TEAEs); plasma and urine concentrations of THC, CBD and metabolites; and self-reported subjective effects were collected. Nearly all TEAEs (44/45) were of mild or moderate severity; none was serious. The highest incidence of TEAEs (67%) was in the two higher-dose treatment groups. The highest number of TEAEs (17/45) occurred on the first treatment day. Steady-state plasma CBD concentrations were reached by Day 7. On Day 7, CBD exposure showed dose proportionality (AUC0-t slope = 1.03 [0.70, 1.36], Cmax slope = 0.92 [0.53, 1.31]). Most plasma THC concentrations were below the limit of quantification. Across Days 1 and 7, there were no consistent differences in subjective effects between placebo and active study medication. A prudent approach to improve tolerability with Spectrum Yellow oil might involve initial doses no higher than 240 mg total CBD and 10.8 mg total THC daily in divided doses, with titration upward over time as needed based on tolerability.

Indexed as

CannabidiolCannabisAnalgesicsDronabinolHealthy VolunteersHumansAnalgesicsCannabidiolDronabinol

Identifiers

PMID33710277
PMCPMC9021973
OpenAlexW4224309978

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.