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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 : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

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.

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 : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


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




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. Wechsler Adult Intelligence Scale (WAIS-III) Digit Symbol Test [ Time Frame: 3 hours ]
  6. Hopkins Verbal Learning Test Revised (HVLT) [ Time Frame: 3 hours ]
  7. Standardized Field Sobriety Test [ Time Frame: 3 hours ]


Information from the National Library of Medicine

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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 serious mental illnesses (e.g., severe depression/anxiety, schizophrenia and bipolar disorder)
  • Current severe depression
  • Uncontrolled hypertension (>139/89)
  • Known cardiovascular disease
  • Chronic pulmonary disease (e.g., bronchitis, asthma, COPD, or emphysema)
  • History of seizure disorder
  • Diagnosed inflammatory disease (e.g. Rheumatoid Arthritis (RA))
  • 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
  • Other diagnosed chronic pain syndromes (e.g. fibromyalgia)

Additional Exclusion Criteria for HEALTHY CONTROLS

  • Current acute pain
  • Current chronic pain condition (e.g. fibromyalgia, neuropathy)

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

Locations
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
Principal Investigator: Emily Lindley, PhD University of Colorado, Denver

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: July 3, 2018
Last Verified: July 2018

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

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