Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
33 participants
INTERVENTIONAL
2017-06-01
2023-06-07
Brief Summary
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Detailed Description
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Some inclusion/exclusion criteria are purposely omitted at this time to preserve scientific integrity. They will be included after the trial is complete.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Cannabis
Medium dose THC, single administration, vaporized
Cannabis
vaporized plant material
Placebo for Oxycodone
oral placebo capsule
Oxycodone
5-10 mg oxycodone hydrochloride, single administration, oral
Oxycodone
oral capsule
Placebo for Cannabis
vaporized placebo plant material
Placebo
No active study drug
Placebo for Cannabis
vaporized placebo plant material
Placebo for Oxycodone
oral placebo capsule
Interventions
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Cannabis
vaporized plant material
Oxycodone
oral capsule
Placebo for Cannabis
vaporized placebo plant material
Placebo for Oxycodone
oral placebo capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age ≥21 years
Exclusion Criteria
* 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
* 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)
* Current acute pain
* Current chronic pain condition (e.g. fibromyalgia, neuropathy)
21 Years
ALL
Yes
Sponsors
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University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Emily Lindley, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Countries
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Other Identifiers
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14-1909
Identifier Type: -
Identifier Source: org_study_id
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