Cannabis Versus Oxycodone for Pain Relief

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study investigates the ability of cannabis to reduce chronic back and neck pain and to reduce sensitivity to an acute painful stimulus. Cannabis will be compared to both oxycodone and a placebo.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Colorado, Denver
• Treatments: Oxycodone

Criteria

Overall Inclusion Criteria:

• Previous smoked or vaporized cannabis exposure

• Age ≥21 years

Overall Exclusion Criteria:

• Current substance use disorder

• Current alcohol use disorder

• Past cannabis abuse/dependence

• Current use of amphetamine/methamphetamine, barbiturates, benzodiazepines, cocaine, phencyclidine (PCP), MDMA (ecstasy)

• Prior adverse reaction to cannabis exposure (paranoia, anxiety, etc.)

• Allergy to or prior adverse reaction to oxycodone

• Any condition contraindicative to opioid use (e.g. paralytic ileus)

• History or diagnosis of schizophrenia or bipolar disorder

• Current severe depression

• Uncontrolled hypertension (>139/89)

• Known cardiovascular disease

• Known immune system disorder

• Chronic pulmonary disease (e.g., bronchitis, asthma, COPD, or emphysema)

• History of seizure disorder

• Diagnosed inflammatory disease (e.g. Rheumatoid Arthritis (RA))

• Clinically significant abnormal values on CBC/CMP/EKG tests

• Cognitive disability that interferes with ability to provide consent or understand study procedures

• Inability to refrain from using tobacco for at least 4 hours

• Pregnant females

• Lactating females

Additional Exclusion Criteria for SPINE PATIENTS

• Current regular use of a long acting opioid (e.g. OxyContin, MS Contin, other extended release formulas)

• Current high-dose use of immediate release opioid

• Current high-dose use of nerve-targeted medication

• Other diagnosed chronic pain syndromes of greater severity than spine condition (e.g. knee pain )

• Diagnosed Fibromyalgia

• Neuropathy not associated with spine condition (e.g. diabetic neuropathy)

Additional Exclusion Criteria for HEALTHY CONTROLS

• Current acute pain

• Current chronic pain condition (e.g. fibromyalgia, neuropathy)