Safety and Efficacy of Oral Cannabis in Chronic Spine Pain
University of Colorado, Denver
Summary
The overall objectives of this study are to investigate the efficacy of extended cannabis treatment to reduce patient exposure to prescription opioids through its use 1) as a non-opioid analgesic treatment, and 2) as a therapy for reducing high-dose opioid use in patients with chronic spine pain.
Description
This randomized, placebo-controlled clinical trial is designed to elucidate the role of extended oral cannabis treatment in the alleviation of chronic spine pain and reduction of high-dose opioid use. This trial includes two study arms: Analgesia Arm and Reduction Arm. The Analgesia Arm uses a within-subject crossover design to determine whether daily treatment with an oral cannabis solution for 6 weeks significantly reduces spine pain compared to placebo. The Reduction Arm uses a parallel design to determine whether daily treatment with an oral cannabis solution for 13 weeks results in a grea…
Eligibility
- Age range
- 21–84 years
- Sex
- All
- Healthy volunteers
- No
Some inclusion/exclusion criteria are purposely omitted at this time to preserve scientific integrity. They will be included after the trial is complete. Inclusion Criteria: Self-reported chronic (≥3 months' duration), non-radicular spine pain Exclusion Criteria: Unwilling/unable to refrain from cannabis use (medical or recreational) for 14 days prior to Baseline Visit and throughout the study (other than study drug). This includes whole plant inhalation, edibles, extracts, and topicals. Co-morbid cancer-related pain condition Neuropathic Pain A co-morbid pain condition that is of great…
Interventions
- DrugTHC/CBD
Oral solution containing 5mg THC and 50 mg CBD per 1 ml
- DrugTHC
Oral solution containing 5mg THC per 1 ml
- DrugPlacebo
Oral solution containing no active drug
Location
- University of Colorado Anschutz Medical CampusAurora, Colorado