Cannabis Versus Oxycodone for Pain Relief

  • STATUS
    Recruiting
  • End date
    Jun 28, 2023
  • participants needed
    100
  • sponsor
    University of Colorado, Denver
Updated on 28 September 2021
pain relief
oxycodone
sham treatment
neck pain

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.

Details
Condition Neck Pain, Back Pain, Pain (Pediatric), backpain, backache, Post-Surgical Pain, Chronic Back Pain, Pain
Treatment Oxycodone, Cannabis, Placebo for Cannabis, Placebo for Oxycodone
Clinical Study IdentifierNCT02892591
SponsorUniversity of Colorado, Denver
Last Modified on28 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Previous smoked or vaporized cannabis exposure
Age 21 years

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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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