Oral cannabis for chronic neck and back pain

Safety and Efficacy of Oral Cannabis in Chronic Spine Pain

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: PHASE3
• Study type: Interventional
• Enrollment: 157 (estimated)
• Ages: 21 Years to 84 Years
• Sex: All
• Sponsor: University of Colorado, Denver (other)
• Locations: 1 site (Aurora, Colorado)
• Trial ID: NCT05052541 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Aurora, Colorado

• 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

Conditions: Back Pain, Neck Pain