Cannabis Versus Oxycodone for Pain Relief
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02892591 |
Recruitment Status :
Recruiting
First Posted : September 8, 2016
Last Update Posted : February 9, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Back Pain Neck Pain | Drug: Cannabis Drug: Oxycodone Drug: Placebo for Cannabis Drug: Placebo for Oxycodone | Phase 3 |
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 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 : | September 2021 |
Estimated Study Completion Date : | December 2021 |

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 |
- Pain Numeric Rating Scale (NRS) score (Spine Patients) [ Time Frame: 3 hours ]
- Pain Threshold (kPa) (Healthy Controls) [ Time Frame: 3 hours ]
- Patient Global Impression of Change score [ Time Frame: 3 hours ]
- Drug effect rating [ Time Frame: 3 hours ]
- Psychoactive effect rating [ Time Frame: 3 hours ]
- Mood rating [ Time Frame: 3 hours ]
- Symbol Digit Modalities Test (SDMT) [ Time Frame: 3 hours ]
- Hopkins Verbal Learning Test Revised (HVLT) [ Time Frame: 3 hours ]
- Standardized Field Sobriety Test [ Time Frame: 3 hours ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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)

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
Contact: Emily Lindley, PhD | 303-724-0923 | MJPainStudy@ucdenver.edu |
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 |
Principal Investigator: | Emily Lindley, PhD | University of Colorado, Denver |
Responsible Party: | University of Colorado, Denver |
ClinicalTrials.gov Identifier: | NCT02892591 |
Other Study ID Numbers: |
14-1909 |
First Posted: | September 8, 2016 Key Record Dates |
Last Update Posted: | February 9, 2021 |
Last Verified: | February 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Neck Pain Pain Neurologic Manifestations Oxycodone Analgesics, Opioid Narcotics |
Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents |