Phase 1 Trial of CBD-Dominant Cannabis Oil Found It Safe with Dose-Proportional Absorption
A Phase 1 trial of CBD-dominant cannabis oil (120-480 mg CBD daily) in 43 healthy participants found nearly all side effects were mild to moderate, CBD absorption was dose-proportional, and no consistent subjective effects were reported.
Quick Facts
What This Study Found
CBD showed dose-proportional absorption (AUC slope=1.03, Cmax slope=0.92). Steady-state was reached by Day 7. Nearly all adverse events (44/45) were mild or moderate; none serious. The highest adverse event rates (67%) occurred in the two higher-dose groups. Most THC concentrations were below detection limits.
Key Numbers
43 participants. Doses: 120-480 mg CBD daily (with 5.4-21.6 mg THC). Adverse events: 44/45 mild-moderate, 0 serious. Highest AE rate: 67% in top two dose groups. Most AEs on first treatment day (17/45). CBD AUC slope: 1.03 (dose-proportional). Recommended starting dose: no higher than 240 mg CBD/10.8 mg THC daily.
How They Did This
Phase 1, multiple-dose, randomized, placebo-controlled study. 43 healthy participants received one of four CBD doses (120-480 mg/day with corresponding THC 5.4-21.6 mg/day) or placebo, administered every 12 hours for 7 consecutive days.
Why This Research Matters
Proper dosing information for cannabis products is severely lacking. This is one of the first rigorous Phase 1 pharmacokinetic studies of a standardized cannabis oil, providing the kind of data physicians need to make informed dosing decisions.
The Bigger Picture
This represents the type of pharmaceutical-grade research that cannabis medicine has long needed. By providing PK/PD data comparable to standard drug development, it helps bridge the gap between patient use and evidence-based medicine.
What This Study Doesn't Tell Us
Conducted in healthy participants, so results may differ in patient populations. Seven-day duration is short relative to typical medical cannabis use. The product contained both CBD and THC, so effects cannot be attributed to CBD alone.
Questions This Raises
- ?Would the pharmacokinetic profile differ in patients with liver disease or those taking medications that affect CBD metabolism?
- ?What happens with longer-term use beyond 7 days?
- ?How does food intake affect absorption?
Trust & Context
- Key Stat:
- Recommended starting dose: ≤240 mg CBD + 10.8 mg THC daily in divided doses
- Evidence Grade:
- Moderate: randomized, placebo-controlled Phase 1 design, but small sample and conducted in healthy participants only.
- Study Age:
- Published in 2022.
- Original Title:
- Safety, Pharmacokinetics and Pharmacodynamics of Spectrum Yellow Oil in Healthy Participants.
- Published In:
- Journal of analytical toxicology, 46(4), 393-407 (2022)
- Authors:
- Peters, Erica N(8), Mosesova, Irina(2), MacNair, Laura(3), Vandrey, Ryan, Land, M Hunter, Ware, Mark A, Turcotte, Cynthia, Bonn-Miller, Marcel O
- Database ID:
- RTHC-04140
Evidence Hierarchy
Participants are randomly assigned to treatment or placebo groups to test cause and effect.
What do these levels mean? →Frequently Asked Questions
What is a safe starting dose for CBD oil?
This study recommended starting at no higher than 240 mg total CBD and 10.8 mg total THC daily in divided doses, with gradual upward titration based on tolerability. Higher doses had more side effects, especially on the first day.
Did participants get high from the CBD oil?
No consistent subjective effects were reported between placebo and active treatment groups, and most THC blood levels were below detection limits, suggesting the CBD-dominant formulation did not produce noticeable intoxication.
Read More on RethinkTHC
- CBD-oil-quality-guide
- anxiety-medication-after-quitting-weed
- cannabis-chemotherapy-nausea
- cannabis-chronic-pain-research
- cannabis-epilepsy-CBD-Epidiolex
- cbd-anxiety-research-evidence
- cbd-for-weed-withdrawal
- cbd-vs-thc-difference
- medical-benefits-of-cannabis
- quitting-weed-before-surgery
- quitting-weed-medication-interactions
- quitting-weed-pregnancy
- quitting-weed-pregnant
- seniors-older-adults-cannabis-risks-medications
- weed-breastfeeding-THC-breast-milk
Cite This Study
https://rethinkthc.com/research/RTHC-04140APA
Peters, Erica N; Mosesova, Irina; MacNair, Laura; Vandrey, Ryan; Land, M Hunter; Ware, Mark A; Turcotte, Cynthia; Bonn-Miller, Marcel O. (2022). Safety, Pharmacokinetics and Pharmacodynamics of Spectrum Yellow Oil in Healthy Participants.. Journal of analytical toxicology, 46(4), 393-407. https://doi.org/10.1093/jat/bkab026
MLA
Peters, Erica N, et al. "Safety, Pharmacokinetics and Pharmacodynamics of Spectrum Yellow Oil in Healthy Participants.." Journal of analytical toxicology, 2022. https://doi.org/10.1093/jat/bkab026
RethinkTHC
RethinkTHC Research Database. "Safety, Pharmacokinetics and Pharmacodynamics of Spectrum Ye..." RTHC-04140. Retrieved from https://rethinkthc.com/research/peters-2022-safety-pharmacokinetics-and-pharmacodynamics
Access the Original Study
Study data sourced from PubMed, a service of the U.S. National Library of Medicine, National Institutes of Health.
This study breakdown was produced by the RethinkTHC research team. We analyze and report published research findings without making health recommendations. All interpretations are based solely on the published abstract and study data.