Cannabis Versus Oxycodone for Pain Relief

• ClinicalTrials.gov Identifier: NCT02892591
• Recruitment Status: Recruiting
• First Posted: September 8, 2016
• Last Update Posted: April 4, 2019
• Sponsor: University of Colorado, Denver
• Information provided by (Responsible Party): University of Colorado, Denver

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Back Pain; Neck Pain	Drug: Cannabis; Drug: Oxycodone; Drug: Placebo for Cannabis; Drug: Placebo for Oxycodone	Phase 3

Detailed 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.

Study Design

• 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: December 2020
• Estimated Study Completion Date: December 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Pain Numeric Rating Scale (NRS) score (Spine Patients) [ Time Frame: 3 hours ]
2. Pain Threshold (kPa) (Healthy Controls) [ Time Frame: 3 hours ]

Secondary Outcome Measures :

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 ]

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Contacts

Contact: Emily Lindley, PhD; 303-724-0923; MJPainStudy@ucdenver.edu

Locations

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

Sponsors and Collaborators

University of Colorado, Denver

Investigators

• Principal Investigator: Emily Lindley, PhD; University of Colorado, Denver

More Information

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT02892591 History of Changes
• Other Study ID Numbers: 14-1909
• First Posted: September 8, 2016
• Last Update Posted: April 4, 2019
• Last Verified: April 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Back Pain; Neck Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Oxycodone; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents