CBD sublingual wafer achieved comparable blood levels to oil and nabiximols spray
In 12 healthy volunteers, a CBD sublingual wafer delivered equivalent CBD concentrations to oil solution and nabiximols spray, with mild side effects including drowsiness and mood changes.
Quick Facts
What This Study Found
CBD sublingual wafer bioavailability was comparable to oil solution (90% CI: 83-131%). Median peak CBD concentrations were 11.9 ng/mL (wafer) and 9.4 ng/mL (oil). Peak concentrations occurred 4 hours after administration with an elimination half-life of approximately 6 hours. No significant difference in total CBD exposure between wafer, oil, and nabiximols spray. Adverse events included mild somnolence, sedation, and altered mood.
Key Numbers
12 volunteers. Wafer peak CBD: 11.9 ng/mL. Oil peak CBD: 9.4 ng/mL. Time to peak: 4 hours. Half-life: ~6 hours. Relative bioavailability wafer vs. oil: 83-131% (90% CI). Multiple-dose: 50 mg twice daily for 5 days.
How They Did This
Phase I open-label, 4-way crossover trial in 12 healthy volunteers. Single doses of CBD sublingual wafer (25 or 50 mg), oil solution (50 mg), or nabiximols spray (20 mg CBD + 21.6 mg THC) administered in randomized sequence. Multiple-dose arm: 50 mg wafer twice daily for 5 days.
Why This Research Matters
CBD delivery format matters for patients. A sublingual wafer could offer advantages in dosing precision and convenience compared to oil or spray formulations. This study establishes that the wafer format does not sacrifice bioavailability.
The Bigger Picture
As CBD products multiply, understanding how different delivery methods affect blood levels is essential for dosing consistency. This small Phase I trial provides pharmacokinetic groundwork for a newer formulation type.
What This Study Doesn't Tell Us
Very small sample (12 volunteers). Healthy volunteers only. Single-dose primary assessment. Open-label design. Cannabis extract composition may vary between products.
Questions This Raises
- ?How does wafer performance differ in patients vs. healthy volunteers?
- ?Would higher doses maintain the bioequivalence?
- ?How does food intake affect wafer absorption?
Trust & Context
- Key Stat:
- Sublingual wafer and oil achieved equivalent CBD bioavailability
- Evidence Grade:
- Very small Phase I study in healthy volunteers. Preliminary pharmacokinetic data only.
- Study Age:
- 2021 Phase I pharmacokinetic study.
- Original Title:
- A phase I trial of the safety, tolerability and pharmacokinetics of cannabidiol administered as single-dose oil solution and single and multiple doses of a sublingual wafer in healthy volunteers.
- Published In:
- British journal of clinical pharmacology, 87(4), 2070-2077 (2021)
- Authors:
- Hosseini, Adele, McLachlan, Andrew J(3), Lickliter, Jason D
- Database ID:
- RTHC-03206
Evidence Hierarchy
Participants are randomly assigned to treatment or placebo groups to test cause and effect.
What do these levels mean? →Frequently Asked Questions
How long does it take for CBD to reach peak levels?
In this study, peak CBD concentrations occurred about 4 hours after taking either the sublingual wafer or oil solution, with an elimination half-life of approximately 6 hours.
Were there any side effects?
Side effects were mild and included drowsiness, sedation, and altered mood. Both the wafer and oil formulations were generally well tolerated.
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-03206APA
Hosseini, Adele; McLachlan, Andrew J; Lickliter, Jason D. (2021). A phase I trial of the safety, tolerability and pharmacokinetics of cannabidiol administered as single-dose oil solution and single and multiple doses of a sublingual wafer in healthy volunteers.. British journal of clinical pharmacology, 87(4), 2070-2077. https://doi.org/10.1111/bcp.14617
MLA
Hosseini, Adele, et al. "A phase I trial of the safety, tolerability and pharmacokinetics of cannabidiol administered as single-dose oil solution and single and multiple doses of a sublingual wafer in healthy volunteers.." British journal of clinical pharmacology, 2021. https://doi.org/10.1111/bcp.14617
RethinkTHC
RethinkTHC Research Database. "A phase I trial of the safety, tolerability and pharmacokine..." RTHC-03206. Retrieved from https://rethinkthc.com/research/hosseini-2021-a-phase-i-trial
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.