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Cannabis Versus Oxycodone for Pain Relief

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ClinicalTrials.gov Identifier: NCT02892591
Recruitment Status : Recruiting
First Posted : September 8, 2016
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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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.

Condition or disease Intervention/treatment Phase
Back Pain Neck Pain Drug: Cannabis Drug: Oxycodone Drug: Placebo for Cannabis Drug: Placebo for Oxycodone Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Crossover Study Comparing the Analgesic Efficacy of Cannabis Versus Oxycodone
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cannabis
Medium dose THC, single administration, vaporized
 Drug: Cannabis
vaporized plant material
Other Name: 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 Cannabis
vaporized placebo plant material

Drug: Placebo for Oxycodone
oral placebo capsule


Outcome Measures
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Primary Outcome Measures :
  1. Pain Numeric Rating Scale (NRS) score (Spine Patients) [ Time Frame: 3 hours ]
  2. Pain Threshold (kPa) (Healthy Controls) [ Time Frame: 3 hours ]

Secondary Outcome Measures :
  1. Patient Global Impression of Change score [ Time Frame: 3 hours ]
  2. Drug effect rating [ Time Frame: 3 hours ]
  3. Psychoactive effect rating [ Time Frame: 3 hours ]
  4. Mood rating [ Time Frame: 3 hours ]
  5. Symbol Digit Modalities Test (SDMT) [ Time Frame: 3 hours ]
  6. Hopkins Verbal Learning Test Revised (HVLT) [ Time Frame: 3 hours ]
  7. Standardized Field Sobriety Test [ Time Frame: 3 hours ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02892591


Contacts
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Contact: Emily Lindley, PhD 303-724-0923 MJPainStudy@ucdenver.edu

Locations
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United States, Colorado
University of Colorado Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Emily Lindley, PhD    303-724-0923    MJPainStudy@ucdenver.edu   
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Emily Lindley, PhD University of Colorado, Denver
More Information
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02892591     History of Changes
Other Study ID Numbers: 14-1909
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Back Pain
Neck Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Oxycodone
Analgesics, Opioid
 Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents