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Completed

NCT Number: NCT02892591

Cannabis Versus Oxycodone for Pain Relief

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cannabis

Drug

vaporized plant material

Other names: marijuana

Oxycodone

Drug

oral capsule

Placebo for Cannabis

Drug

vaporized placebo plant material

Placebo for Oxycodone

Drug

oral placebo capsule

Primary outcomes

  1. Pain Numeric Rating Scale (NRS) score (Spine Patients)

    Time frame: 3 hours

  2. Pain Threshold (kPa) (Healthy Controls)

    Time frame: 3 hours

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Sep 8, 2016
Registry last updated
Feb 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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