Actively Recruiting
Safety and Efficacy of Oral Cannabis in Chronic Spine Pain
Led by University of Colorado, Denver · Updated on 2026-01-23
157
Participants Needed
1
Research Sites
73 weeks
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
I
Institute of Cannabis Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy of Oral Cannabis in Chronic Spine Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Self-reported chronic (≥3 months' duration), non-radicular spine pain
You will not qualify if you...
- Unwilling or unable to refrain from cannabis use (medical or recreational) for 14 days before baseline and throughout the study, except study drug
- Co-morbid cancer-related pain condition
- Neuropathic pain
- A co-morbid pain condition more severe than spine pain
- Spine or other major surgery within 3 months prior to enrollment
- Planned surgery or procedural intervention during the study
- Allergy or adverse reaction to cannabis
- Current or history of substance use disorder
- Current or history of alcohol use disorder
- Current or prior cannabis abuse or dependence
- Positive urine screen for amphetamines, barbiturates, benzodiazepines, cocaine, PCP, MDMA
- Current use of valproate, clobazam, clopidogrel, warfarin, barbiturates, or benzodiazepines
- Prior adverse reaction to cannabis exposure (paranoia, anxiety, etc.)
- History or diagnosis of schizophrenia, bipolar, or psychotic disorder
- History of mental illness compromising safety as judged by investigator
- Current or historical severe depression
- Current suicidal thoughts
- Diagnosed cognitive impairment (e.g., Alzheimer's, traumatic brain injury)
- Uncontrolled hypertension (>139/89)
- Clinically significant abnormal CBC or CMP labs
- Known hepatic disease or dysfunction
- Known cardiovascular disease
- Clinically significant abnormal ECG
- Cognitive disability interfering with consent or understanding
- History of seizure disorder
- Medical condition requiring immunosuppressive therapy
- Inability to refrain from tobacco for at least 4 hours
- Condition or abnormality compromising safety or data quality
- Pending legal action or workers compensation
- Pregnant, intending pregnancy, or lactating females
- Unwilling to use accepted contraception during study and 60 days after (for females of childbearing potential and males with partners of childbearing potential)
- Analgesia Arm: unwilling or unable to discontinue current opioid use for 14 days prior and throughout study
- Reduction Arm: not interested in reducing or stopping prescribed opioids
- Reduction Arm: unwilling to allow communication with opioid prescriber
- Additional criteria withheld to preserve scientific integrity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
M
Mustafa Al-Mafrachi, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
8
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here