NCT05052541

Safety and Efficacy of Oral Cannabis in Chronic Spine Pain

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 157 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 21 Years – 84 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 greater reduction of pain and opioid intake than placebo treatment. It will also assess the impact of extended cannabis treatment on opioid craving and symptoms of opioid withdrawal in participants tapering their high-dose opioids.

Conditions

• Back Pain
• Neck Pain

Interventions

Type	Name	Description
DRUG	THC/CBD	Oral solution containing 5mg THC and 50 mg CBD per 1 ml
DRUG	THC	Oral solution containing 5mg THC per 1 ml
DRUG	Placebo	Oral solution containing no active drug

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2021-09-22
• Last updated: 2026-01-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study