Safety and Efficacy of Oral Cannabis in Chronic Spine Pain

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT05052541
Phase
PHASE3
Status
Recruiting
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Conditions

  • Back Pain
  • Neck Pain

Eligibility Criteria

Sex
ALL
Age
21 Years - 84 Years
Healthy Volunteers
Not accepted

Interventions

  • THC/CBD — DRUG
    Oral solution containing 5mg THC and 50 mg CBD per 1 ml
  • THC — DRUG
    Oral solution containing 5mg THC per 1 ml
  • Placebo — DRUG
    Oral solution containing no active drug

Study Details

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.

Key Dates

Start date
Jan 31, 2026
Status verified
Jan 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
157 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Analgesia Arm: THC (tetrahydrocannabinol), then THC/CBD (cannabidiol), then Placebo
    Subjects in this crossover arm will be assigned to 6 weeks on THC oral solution, then 6 weeks on THC/CBD oral solution, then 6 weeks on Placebo oral solution. Frequency of drug administration is 3-4 times a day.
  • Experimental: Analgesia Arm: THC, then Placebo, then THC/CBD
    Subjects in this crossover arm will be assigned to 6 weeks on THC oral solution, then 6 weeks on Placebo oral solution, then 6 weeks on THC/CBD oral solution. Frequency of drug administration is 3-4 times a day.
  • Experimental: Analgesia Arm: THC/CBD, then THC, then Placebo
    Subjects in this crossover arm will be assigned to 6 weeks on THC/CBD oral solution, then 6 weeks on THC oral solution, then 6 weeks on Placebo oral solution. Frequency of drug administration is 3-4 times a day.
  • Experimental: Analgesia Arm: THC/CBD, then Placebo, then THC
    Subjects in this crossover arm will be assigned to 6 weeks on THC/CBD oral solution, then 6 weeks on Placebo oral solution, then 6 weeks on THC oral solution. Frequency of drug administration is 3-4 times a day.
  • Experimental: Analgesia Arm: Placebo, then THC, then THC/CBD
    Subjects in this crossover arm will be assigned to 6 weeks on Placebo oral solution, then 6 weeks on THC oral solution, then 6 weeks on THC/CBD oral solution. Frequency of drug administration is 3-4 times a day.
  • Experimental: Analgesia Arm: Placebo, then THC/CBD, then THC
    Subjects in this crossover arm will be assigned to 6 weeks on Placebo oral solution, then 6 weeks on THC/CBD oral solution, then 6 weeks on THC oral solution. Frequency of drug administration is 3-4 times a day.
  • Experimental: Reduction Arm: THC/CBD
    Subjects in this parallel arm will be assigned to 13 weeks on THC/CBD oral solution. Frequency of drug administration is 3-4 times a day.
  • Placebo Comparator: Reduction Arm: Placebo
    Subjects in this parallel arm will be assigned to 13 weeks on Placebo oral solution. Frequency of drug administration is 3-4 times a day.

Primary Outcome Measure

Change in chronic pain as measured by the Visual Analog Scale (VAS) for pain [ Time Frame: Weekly, up to week 22 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado Anschutz Medical CampusAuroraColorado80045
Emily Lindley, PhD
[email protected]
303-724-0239
Rachael Rzasa Lynn, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Colorado Anschutz Medical Campus· Aurora, CO

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