Back Pain, Neck Pain
Conditions
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.
Interventions
DRUGCannabis
vaporized plant material
DRUGOxycodone
oral capsule
DRUGPlacebo for Cannabis
vaporized placebo plant material
DRUGPlacebo for Oxycodone
oral placebo capsule
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain Threshold (kPa) (Healthy Controls) | 3 hours |
| Pain Numeric Rating Scale (NRS) score (Spine Patients) | 3 hours |
Secondary
| Measure | Time frame |
|---|---|
| Hopkins Verbal Learning Test Revised (HVLT) | 3 hours |
| Standardized Field Sobriety Test | 3 hours |
| Mood rating | 3 hours |
| Patient Global Impression of Change score | 3 hours |
| Drug effect rating | 3 hours |
| Psychoactive effect rating | 3 hours |
| Symbol Digit Modalities Test (SDMT) | 3 hours |
Countries
United States
Outcome results
None listed