Verified August 2016 by University of Colorado, Denver
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT02892591
First received: September 2, 2016
Last updated: September 2, 2016
Last verified: August 2016
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.
| Back Pain Neck Pain |
Drug: Cannabis Drug: Oxycodone Drug: Placebo for Cannabis Drug: Placebo for Oxycodone |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Double-Blind, Placebo-Controlled Crossover Study Comparing the Analgesic Efficacy of Cannabis Versus Oxycodone |
- Pain Numeric Rating Scale (NRS) score (Spine Patients) [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
- Pain Threshold (kPa) (Healthy Controls) [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
- Patient Global Impression of Change score [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
- Drug effect rating [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
- Psychoactive effect rating [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
- Mood rating [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
- Wechsler Adult Intelligence Scale (WAIS-III) Digit Symbol Test [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
- Hopkins Verbal Learning Test Revised (HVLT) [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
- Standardized Field Sobriety Test [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | October 2016 |
| Estimated Study Completion Date: | June 2019 |
| Estimated Primary Completion Date: | June 2019 (Final data collection date for primary outcome measure) |
| Experimental: Cannabis
4.7% THC, single dose, vaporized |
Drug: Cannabis
Other Name: marijuana Drug: Placebo for Oxycodone |
| Active Comparator: Oxycodone
5-10 mg oxycodone hydrochloride, single dose, oral |
Drug: Oxycodone Drug: Placebo for Cannabis |
| Placebo Comparator: Placebo
No active study drug |
Drug: Placebo for Cannabis Drug: Placebo for Oxycodone |
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.
| Ages Eligible for Study: | 21 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Overall Inclusion Criteria:
- Previous smoked or vaporized cannabis exposure
- Age ≥21 years
Overall Exclusion Criteria:
- Current use of cannabis > once a week
- Use of cannabis or other synthetic THC medications (e.g., Marinol; Solvay Pharmaceuticals, Inc, Marietta, GA; cannabis oils, edibles, etc.) within 2 weeks of study sessions
- 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 serious mental illnesses (e.g., severe depression/anxiety, schizophrenia and bipolar disorder)
- Current severe depression
- Uncontrolled hypertension (>139/89)
- Known cardiovascular disease
- Chronic pulmonary disease (e.g., bronchitis, asthma, COPD, or emphysema)
- History of seizure disorder
- Diagnosed inflammatory disease (e.g. RA)
- Cognitive disability that interferes with ability to provide consent or understand study procedure
- Inability to refrain from using tobacco for at least 4 hours
- Pending legal action or workers compensation
- Pregnant females
- Lactating females
Additional Exclusion Criteria for SPINE PATIENTS
- Current pain score on NRS < 6
- Spine pain condition for <12 weeks
- 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 (> 45 mg morphine equivalents/day)
- Use of immediate release opioid within 6 hours of study sessions
- Other diagnosed chronic pain syndromes (e.g. fibromyalgia)
Additional Exclusion Criteria for HEALTHY CONTROLS
- Current acute pain
- Current chronic pain condition (e.g. fibromyalgia, neuropathy)
- Use of OTC or prescription pain medication within 24 hours of study sessions
Please refer to this study by its ClinicalTrials.gov identifier: NCT02892591
University of Colorado, Denver
| Principal Investigator: | Emily Lindley, PhD | University of Colorado, Denver |
| Responsible Party: | University of Colorado, Denver |
| ClinicalTrials.gov Identifier: | NCT02892591 History of Changes |
| Other Study ID Numbers: | 14-1909 |
| Study First Received: | September 2, 2016 |
| Last Updated: | September 2, 2016 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
| Back Pain Neck Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Oxycodone |
Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on September 07, 2016