NCT02460692

Trial of Dronabinol and Vaporized Cannabis in Chronic Low Back Pain

A Randomized Controlled Trial of Dronabinol and Vaporized Cannabis in Chronic Low Back Pain

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 19 Years – 70 Years
• Healthy volunteers: Not accepted

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 .

Detailed description

The present study is designed to assess whether treatment with vaporized cannabis or dronabinol (oral Δ9-THC) reduces spontaneous and evoked pain more than placebo, and whether there are any differences between the two active treatments in terms of interference with activities of daily living. This study also aims to examine the effects of vaporized whole plant cannabis and dronabinol on mood, neuropsychological function, and psychomimetic side-effects (high, stoned, etc.) compared to placebo and to each other. In addition, we plan to examine the acute effects (after receiving stable treatment for 4 weeks) of vaporized cannabis and dronabinol compared to placebo and each other on driving skills.

Conditions

• Cannabis
• Low Back Pain
• Neuropathic Pain

Interventions

Type	Name	Description
DRUG	Placebos	Administration of vaporized cannabis plus either dronabinol or placebo pill
DRUG	dronabinol	Administration of vaporized cannabis plus either dronabinol or placebo pill
DRUG	Vaporized Cannabis 3.7% THC/5.6% CBD	Administration of vaporized cannabis plus either dronabinol or placebo pill

Timeline

• Start date: 2016-12-01
• Primary completion: 2020-03-25
• Completion: 2020-03-25
• First posted: 2015-06-02
• Last updated: 2023-09-28
• Results posted: 2023-09-28

Locations

1 site across 1 country: United States