Cannabis Versus Oxycodone for Pain Relief

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Some inclusion/exclusion criteria are purposely omitted at this time to preserve scientific integrity. They will be included after the trial is complete.

Official Title
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A Double-Blind, Placebo-Controlled Crossover Study Comparing the Analgesic Efficacy of Cannabis Versus Oxycodone

Conditions
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Back Pain, Neck Pain

Intervention / Treatment
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* Drug: Cannabis
* Drug: Oxycodone
* Drug: Placebo for Cannabis
* Drug: Placebo for Oxycodone


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cannabis<br>Medium dose THC, single administration, vaporized | Drug: Cannabis<br>* vaporized plant material<br>* Other names: marijuana;Drug: Placebo for Oxycodone<br>* oral placebo capsule<br>|
| Active Comparator: Oxycodone<br>5-10 mg oxycodone hydrochloride, single administration, oral | Drug: Oxycodone<br>* oral capsule<br>Drug: Placebo for Cannabis<br>* vaporized placebo plant material<br>|
| Placebo Comparator: Placebo<br>No active study drug | Drug: Placebo for Cannabis<br>* vaporized placebo plant material<br>Drug: Placebo for Oxycodone<br>* oral placebo capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Numeric Rating Scale (NRS) score (Spine Patients) |  | 3 hours | 
| Pain Threshold (kPa) (Healthy Controls) |  | 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Global Impression of Change score |  | 3 hours | 
| Drug effect rating |  | 3 hours | 
| Psychoactive effect rating |  | 3 hours | 
| Mood rating |  | 3 hours | 
| Symbol Digit Modalities Test (SDMT) |  | 3 hours | 
| Hopkins Verbal Learning Test Revised (HVLT) |  | 3 hours | 
| Standardized Field Sobriety Test |  | 3 hours |