Oral cannabis for chronic neck and back pain
Official title: Safety and Efficacy of Oral Cannabis in Chronic Spine Pain
Run by University of Colorado, Denver · NCT05052541 · Data updated 2026-11-12
This trial will test whether a daily oral cannabis solution can reduce spine pain and help people with chronic back or neck pain lower their high-dose opioid use.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 21 Years to 84 Years |
| Sex | All |
| Enrollment | 157 (estimated) |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Status | Recruiting |
| Started | January 2026 |
| Main results expected | June 2027 |
| Study ends | June 2027 |
| Registry record updated | January 23, 2026 |
| Trial ID | NCT05052541 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with chronic (≥3 months) non-radicular back or neck pain, including those taking high-dose prescription opioids who can abstain from other cannabis use and are willing to follow study procedures, are the intended participants.
✕Probably not a fit
People with neuropathic or cancer-related pain, a more severe coexisting pain condition, current or past substance or alcohol use disorder, cannabis dependence, recent major surgery, or inability to stop non-study cannabis use are unlikely to be eligible or to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, placebo-controlled Phase 3 trial at the University of Colorado examining extended oral cannabis treatment for chronic non-radicular spine pain. It has two arms: an Analgesia Arm with a within-subject crossover comparing 6 weeks of daily oral cannabis versus placebo for pain reduction, and a Reduction Arm using a parallel design comparing 13 weeks of daily oral cannabis versus placebo for pain and opioid dose reduction. The trial looks at opioid craving and withdrawal symptoms among participants tapering high-dose opioids and uses THC/CBD, THC-only, and placebo formulations. Participants must abstain from non-study cannabis use and meet specified inclusion/exclusion criteria.
Why it matters
Potential benefit: If successful, oral cannabis could both relieve chronic spine pain and help people reduce or taper high-dose opioid medications, lowering opioid-related risks.
How similar studies have gone: Prior small trials and observational studies have shown mixed and generally modest pain relief from cannabinoids, and long-term oral cannabis use specifically for opioid dose reduction remains largely unproven.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 greater severity than the patient's spine pain Spine or other major surgery within the 3 months prior to enrollment Planned surgery or procedural intervention during the study period Allergy or adverse reaction to cannabis Current or historical substance use disorder Current or historical alcohol use disorder Current or prior cannabis abuse/dependence Positive result for use of amphetamine/methamphetamine, barbiturates, benzodiazepines, cocaine, phencyclidine (PCP), ecstasy (MDMA), as detected on urine screen Current use of valproate, clobazam, clopidogrel, warfarin, barbiturates, benzodiazepines Prior adverse reaction to cannabis exposure (paranoia, anxiety, etc.) History or diagnosis of schizophrenia, bipolar or a psychotic disorder History of any mental health illness that in the opinion of the Investigator would compromise the safety of the participant Current or historical severe depression Current suicidal ideation Diagnosed cognitive impairment (e.g. Alzheimer's Disease, traumatic brain injury) Uncontrolled hypertension (\>139/89) Abnormal values on CBC (complete blood count) or CMP (comprehensive metabolic panel) laboratory analysis that are deemed clinically significant by study physician Known hepatic disease or dysfunction, or identification of such on screening laboratory studies Known cardiovascular disease Abnormal result on electrocardiogram (ECG) that is deemed clinically significant by study MD Cognitive disability that interferes with ability to provide consent or understand study procedure History of seizure disorder Any medical condition for which immunosuppressive therapy is required. Inability to refrain from using tobacco for at least 4 hours Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the participant or the quality of the data Pending legal action or workers compensation Pregnant females or females intending to become pregnant during the study period Unwilling to use one of the accepted forms of contraception during the study period and for at least 60 days after completion of the study (females of childbearing potential and males with sexual partners of childbearing potential) Lactating females Analgesia Arm Exclusion Criteria: Unwilling/unable to discontinue current opioid use for 14 days prior to Baseline study visit and throughout the study Reduction Arm Exclusion Criteria: Not interested in reducing or discontinuing use of prescribed opioids for chronic pain Unwilling to allow the study team to communicate with the participant's opioid prescribing provider \*Some inclusion/exclusion criteria are purposely omitted at this time to preserve scientific integrity. They will be included after the trial is complete.
Where it's running
-
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States Recruiting
Study contacts
- Principal investigator: Emily Lindley, PhD — University of Colorado, Denver
- Study coordinator: Mustafa Al-Mafrachi, MPH
- Email: spinepainstudy@cuanschutz.edu
- Phone: 303-724-0923
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.