Cannabis Versus Oxycodone for Pain Relief
Phase 3
Completed
- Conditions
- Back PainNeck Pain
- Interventions
- Registration Number
- NCT02892591
- Lead Sponsor
- University of Colorado, Denver
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Cannabis Cannabis Medium dose THC, single administration, vaporized Cannabis Placebo for Oxycodone Medium dose THC, single administration, vaporized Oxycodone Oxycodone 5-10 mg oxycodone hydrochloride, single administration, oral Oxycodone Placebo for Cannabis 5-10 mg oxycodone hydrochloride, single administration, oral Placebo Placebo for Cannabis No active study drug Placebo Placebo for Oxycodone No active study drug
- Primary Outcome Measures
Name Time Method Pain Numeric Rating Scale (NRS) score (Spine Patients) 3 hours Pain Threshold (kPa) (Healthy Controls) 3 hours
- Secondary Outcome Measures
Name Time Method Drug effect rating 3 hours Psychoactive effect rating 3 hours Mood rating 3 hours Patient Global Impression of Change score 3 hours Symbol Digit Modalities Test (SDMT) 3 hours Hopkins Verbal Learning Test Revised (HVLT) 3 hours Standardized Field Sobriety Test 3 hours
Trial Locations
- Locations (1)
University of Colorado Anschutz Medical Campus
🇺🇸Aurora, Colorado, United States