Head-to-head comparison of Sativex abuse potential versus pure synthetic THC
In 23 recreational cannabis users, Sativex (THC+CBD spray) showed similar or slightly less abuse potential compared to equivalent doses of dronabinol (pure synthetic THC).
Quick Facts
What This Study Found
This crossover study gave 23 recreational cannabis users single doses of Sativex (at three dose levels), dronabinol (at two dose levels), or placebo. At the lowest dose (10.8 mg THC), Sativex was not significantly different from placebo on primary abuse potential measures.
At the medium dose (21.6 mg THC), Sativex showed some abuse potential on certain measures. At the highest dose (43.2 mg THC), Sativex showed significant effects on most abuse measures, roughly comparable to dronabinol 40 mg.
Critically, at every dose comparison, Sativex scores were numerically equal to or lower than equivalent dronabinol doses. This confirmed that adding CBD and using oromucosal delivery did not increase abuse potential beyond that of pure THC.
Key Numbers
23 recreational cannabis users. Sativex 10.8 mg: not different from placebo on primary measures. Sativex 43.2 mg and dronabinol 40 mg: generally not statistically different from each other. Sativex scores consistently equal to or lower than equivalent dronabinol.
How They Did This
Single-dose, randomized, double-blind, crossover study. 23 recreational cannabis users received Sativex (10.8, 21.6, and 43.2 mg THC), dronabinol (20 and 40 mg), and matching placebos. Subjective and cognitive measures were assessed over 24 hours post-dose.
Why This Research Matters
This study directly addressed the regulatory concern about whether a THC-containing medicine could be abused. By showing Sativex had no greater abuse potential than already-approved dronabinol, it supported the case for regulatory approval.
The Bigger Picture
This was a key regulatory study. By demonstrating that Sativex had no greater abuse potential than dronabinol (which was already classified as Schedule III), it supported appropriate scheduling and prescription access for patients.
What This Study Doesn't Tell Us
Single-dose design does not capture repeated-use patterns. Recreational cannabis users represent a high-risk population, so abuse potential in pain or MS patients may be lower. The study was funded by GW Pharmaceuticals, Sativex's manufacturer.
Questions This Raises
- ?Does the abuse potential profile change with repeated dosing?
- ?Would results differ in non-cannabis-experienced populations?
- ?How much of the reduced abuse potential comes from CBD versus the slow delivery route?
Trust & Context
- Key Stat:
- Sativex abuse scores were consistently equal to or lower than dronabinol
- Evidence Grade:
- Well-designed crossover RCT with appropriate comparators and blinding. Moderate sample size for an abuse liability study. Industry-funded.
- Study Age:
- Published in 2011. This study contributed to Sativex's regulatory approval in multiple countries.
- Original Title:
- A randomized, double-blind, placebo-controlled, crossover study to evaluate the subjective abuse potential and cognitive effects of nabiximols oromucosal spray in subjects with a history of recreational cannabis use.
- Published In:
- Human psychopharmacology, 26(3), 224-36 (2011)
- Authors:
- Schoedel, Kerri Alexandra, Chen, Nancy, Hilliard, Annie, White, Linda, Stott, Colin, Russo, Ethan, Wright, Stephen, Guy, Geoffrey, Romach, Myroslava K, Sellers, Edward M
- Database ID:
- RTHC-00522
Evidence Hierarchy
Participants are randomly assigned to treatment or placebo groups to test cause and effect.
What do these levels mean? →Frequently Asked Questions
Is Sativex less addictive than pure THC?
In this study, Sativex showed similar or slightly lower abuse potential compared to dronabinol (pure synthetic THC) at equivalent doses. The CBD content and spray delivery method may reduce the "high" compared to pure THC.
Why test in recreational cannabis users?
Abuse liability studies intentionally use people experienced with the drug class because they can best detect rewarding effects. If abuse potential is low in this high-risk group, it is likely even lower in typical patients.
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Cite This Study
https://rethinkthc.com/research/RTHC-00522APA
Schoedel, Kerri Alexandra; Chen, Nancy; Hilliard, Annie; White, Linda; Stott, Colin; Russo, Ethan; Wright, Stephen; Guy, Geoffrey; Romach, Myroslava K; Sellers, Edward M. (2011). A randomized, double-blind, placebo-controlled, crossover study to evaluate the subjective abuse potential and cognitive effects of nabiximols oromucosal spray in subjects with a history of recreational cannabis use.. Human psychopharmacology, 26(3), 224-36. https://doi.org/10.1002/hup.1196
MLA
Schoedel, Kerri Alexandra, et al. "A randomized, double-blind, placebo-controlled, crossover study to evaluate the subjective abuse potential and cognitive effects of nabiximols oromucosal spray in subjects with a history of recreational cannabis use.." Human psychopharmacology, 2011. https://doi.org/10.1002/hup.1196
RethinkTHC
RethinkTHC Research Database. "A randomized, double-blind, placebo-controlled, crossover st..." RTHC-00522. Retrieved from https://rethinkthc.com/research/schoedel-2011-a-randomized-doubleblind-placebocontrolled
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.