drugset / Trial / NCT02460692
Trial of Dronabinol and Vaporized Cannabis in Chronic Low Back Pain
Phase 2
Completed
131 enrolled
University of California, San Diego
National Institute on Drug Abuse (NIDA) · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
This study will involve treating low back pain associated with nerve injury with oral delta-9-tetrahydrocannabinol (Δ9-THC) or whole plant cannabis for eight weeks. Research subjects will consume either oral Δ9-THC (dronabinol), vaporized 3.7% Δ9-THC/5.6% CBD, or placebo. An analysis will then be determined to assess the risk--benefit ratio of dronabinol and vaporized 3.7% Δ9-THC/5.6% CBD .
Timeline
- Start
- 2016-12
- Primary completion
- 2020-03-25
- Completion
- 2020-03-25
Publications
- Background Wilsey B, Marcotte T, Tsodikov A, Millman J, Bentley H, Gouaux B, Fishman S. A randomized, placebo-controlled, crossover trial of cannabis cigarettes in neuropathic pain. J Pain. 2008 Jun;9(6):506-21. doi: 10.1016/j.jpain.2007.12.010. Epub 2008 Apr 10.
- Background Wilsey B, Marcotte T, Deutsch R, Gouaux B, Sakai S, Donaghe H. Low-dose vaporized cannabis significantly improves neuropathic pain. J Pain. 2013 Feb;14(2):136-48. doi: 10.1016/j.jpain.2012.10.009. Epub 2012 Dec 11.
- Background Wilsey B, Atkinson JH, Marcotte TD, Grant I. The Medicinal Cannabis Treatment Agreement: Providing Information to Chronic Pain Patients Through a Written Document. Clin J Pain. 2015 Dec;31(12):1087-96. doi: 10.1097/AJP.0000000000000145.
- Background Grant I, Atkinson JH, Gouaux B, Wilsey B. Medical marijuana: clearing away the smoke. Open Neurol J. 2012;6:18-25. doi: 10.2174/1874205X01206010018. Epub 2012 May 4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cannabis | Traditional medicine (herbal / TCM) | 3.7 % | Other |
| Subject | Cannabis | Traditional medicine (herbal / TCM) | 5.6 % | Other |
| Comparator | Dronabinol | Other / unclassified | — | Oral |