Cannabis Versus Oxycodone for Pain Relief

Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02892591
• Other study ID #: 14-1909
• Status: Completed
• Phase: Phase 3
• Start date: June 1, 2017
• Est. completion date: June 7, 2023

Study information

• Verified date: February 2024
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: June 7, 2023
• Est. primary completion date: June 7, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Back Pain
• Neck Pain

Intervention

Drug:
• Cannabis
vaporized plant material
• Oxycodone
oral capsule
• Placebo for Cannabis
vaporized placebo plant material
• Placebo for Oxycodone
oral placebo capsule

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Numeric Rating Scale (NRS) score (Spine Patients)		3 hours
Primary	Pain Threshold (kPa) (Healthy Controls)		3 hours
Secondary	Patient Global Impression of Change score		3 hours
Secondary	Drug effect rating		3 hours
Secondary	Psychoactive effect rating		3 hours
Secondary	Mood rating		3 hours
Secondary	Symbol Digit Modalities Test (SDMT)		3 hours
Secondary	Hopkins Verbal Learning Test Revised (HVLT)		3 hours
Secondary	Standardized Field Sobriety Test		3 hours