Cannabis Versus Oxycodone for Pain Relief

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

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.

Study Overview

• Status: Completed
• Conditions: Back Pain; Neck Pain
• Intervention / Treatment: Drug: Cannabis; Drug: Placebo for Oxycodone; Drug: Oxycodone; Drug: Placebo for Cannabis

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz Medical Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Emily Lindley, PhD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): June 7, 2023
• Study Completion (Actual): June 7, 2023

Study Registration Dates

• First Submitted: September 2, 2016
• First Submitted That Met QC Criteria: September 2, 2016
• First Posted (Estimated): September 8, 2016

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Oxycodone
• Other Study ID Numbers: 14-1909

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No