Clinical trial NCT02892591: Cannabis Versus Oxycodone for Pain Relief
Official title: A Double-Blind, Placebo-Controlled Crossover Study Comparing the Analgesic Efficacy of Cannabis Versus Oxycodone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Back Pain
Neck Pain
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 33
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility 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)

Primary outcomes:
measure: Pain Numeric Rating Scale (NRS) score (Spine Patients)
timeFrame: 3 hours
measure: Pain Threshold (kPa) (Healthy Controls)
timeFrame: 3 hours
Secondary outcomes:
measure: Patient Global Impression of Change score
timeFrame: 3 hours
measure: Drug effect rating
timeFrame: 3 hours
measure: Psychoactive effect rating
timeFrame: 3 hours
measure: Mood rating
timeFrame: 3 hours
measure: Symbol Digit Modalities Test (SDMT)
timeFrame: 3 hours
measure: Hopkins Verbal Learning Test Revised (HVLT)
timeFrame: 3 hours
measure: Standardized Field Sobriety Test
timeFrame: 3 hours
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Emily Lindley, PhD
role: PRINCIPAL_INVESTIGATOR
References: