Dronabinol as an Adjunct for Reducing Pain

Summary

This exploratory, proof-of-concept study is a double-blind (participants and investigators will be blinded), placebo-controlled, randomized, two-arm clinical trial of Marinol \[dronabinol, synthetic Δ9-tetrahydrocannabinol (THC)\] for chronic low back pain (cLBP) with a 2:1 allocation ratio. Up to 75 subjects will be enrolled in this pilot study and randomized to receive doses of THC (up to 30 mg/day), orally, over 8 weeks. This study will be conducted at a single site; it does not include any stratifications, and there is no interim analysis planned. Notably, the goal is to determine whether there is enough evidence of the safety of THC to support the development of later-phase clinical trials. Thus, detailed developmental plans are contingent on the outcomes of this study.

Timeline

Start

2024-06-15

Primary completion

2028-12-31

Completion

2029-12-31

Publications

• Background Fitzcharles MA, Baerwald C, Ablin J, Hauser W. Efficacy, tolerability and safety of cannabinoids in chronic pain associated with rheumatic diseases (fibromyalgia syndrome, back pain, osteoarthritis, rheumatoid arthritis): A systematic review of randomized controlled trials. Schmerz. 2016 Feb;30(1):47-61. doi: 10.1007/s00482-015-0084-3.
• Background Johal H, Devji T, Chang Y, Simone J, Vannabouathong C, Bhandari M. Cannabinoids in Chronic Non-Cancer Pain: A Systematic Review and Meta-Analysis. Clin Med Insights Arthritis Musculoskelet Disord. 2020 Feb 19;13:1179544120906461. doi: 10.1177/1179544120906461. eCollection 2020.
• Background Kraft B, Frickey NA, Kaufmann RM, Reif M, Frey R, Gustorff B, Kress HG. Lack of analgesia by oral standardized cannabis extract on acute inflammatory pain and hyperalgesia in volunteers. Anesthesiology. 2008 Jul;109(1):101-10. doi: 10.1097/ALN.0b013e31817881e1.
• Background Madden A. Commentary on Madden et al. (2018): 'It's not only about the destination... it's also about the journey!' Consumer perspectives on a model of open-access MAT provision. Addiction. 2018 Aug;113(8):1459-1460. doi: 10.1111/add.14273. No abstract available.
• Background Cooper C, Spiers N, Livingston G, Jenkins R, Meltzer H, Brugha T, McManus S, Weich S, Bebbington P. Ethnic inequalities in the use of health services for common mental disorders in England. Soc Psychiatry Psychiatr Epidemiol. 2013 May;48(5):685-92. doi: 10.1007/s00127-012-0565-y. Epub 2012 Aug 15.
• Background Berthelot JM, Darrieutort-Lafitte C, Le Goff B, Maugars Y. Strong opioids for noncancer pain due to musculoskeletal diseases: Not more effective than acetaminophen or NSAIDs. Joint Bone Spine. 2015 Dec;82(6):397-401. doi: 10.1016/j.jbspin.2015.08.003. Epub 2015 Oct 6.
• Background de Vries JD, van Hooff MLM, Geurts SAE, Kompier MAJ. Exercise to reduce work-related fatigue among employees: a randomized controlled trial. Scand J Work Environ Health. 2017 Jul 1;43(4):337-349. doi: 10.5271/sjweh.3634. Epub 2017 Mar 21.
• Strayhorn M, Vaughan A, Davis J, Lo G, Verrico CD. Dronabinol for chronic low back pain in Veterans: protocol for a randomized, double-blind, placebo-controlled, parallel-group trial. Pain Manag. 2026 Jun 10:1-9. doi: 10.1080/17581869.2026.2685608. Online ahead of print.

Drugs

Indications