Cannabis Versus Oxycodone for Pain Relief

University of Colorado Denver (CU Denver)

Status and phase: Completed; Phase 3

Conditions: Back Pain; Neck Pain

Treatments: Drug: Placebo for Cannabis; Drug: Placebo for Oxycodone; Drug: Oxycodone; Drug: Cannabis

Study type: Interventional

Funder types: Other

Identifiers

NCT02892591

14-1909

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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33 participants in 3 patient groups, including a placebo group

Cannabis

Experimental group

Description:

Medium dose THC, single administration, vaporized

Treatment:

Drug: Cannabis

Drug: Placebo for Oxycodone

Oxycodone

Active Comparator group

Description:

5-10 mg oxycodone hydrochloride, single administration, oral

Treatment:

Drug: Oxycodone

Drug: Placebo for Cannabis

Placebo

Placebo Comparator group

Description:

No active study drug

Treatment:

Drug: Placebo for Oxycodone

Drug: Placebo for Cannabis