Safety and Efficacy of Oral Cannabis in Chronic Spine Pain

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Back Pain, Neck Pain

In brief

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 facts

Study ID

NCT05052541

Run by

University of Colorado, Denver

People needed

157

Starts

2026-01-01

Expected to finish

2027-06-01

Last updated by the study team

2026-01-23

Who can join

Age: 21 and older, up to 84. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Self-reported chronic (≥3 months' duration), non-radicular spine pain

You may not qualify if…

• 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

Where it is running

• University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (enrolling)

Full record on ClinicalTrials.gov

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