Cannabis Versus Oxycodone for Pain Relief
Paraules clau
Resum
Descripció
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.
Dates
| Darrera verificació: | 06/30/2020 |
| Primer enviat: | 09/01/2016 |
| Inscripció estimada enviada: | 09/01/2016 |
| Publicat per primera vegada: | 09/07/2016 |
| Última actualització enviada: | 07/06/2020 |
| Publicació de l'última actualització: | 07/08/2020 |
| Data d'inici de l'estudi real: | 05/31/2017 |
| Data estimada de finalització primària: | 12/31/2020 |
| Data estimada de finalització de l’estudi: | 12/31/2020 |
Condició o malaltia
Intervenció / tractament
Drug: Cannabis
Drug: Oxycodone
Drug: Placebo for Cannabis
Drug: Placebo for Oxycodone
Fase
Grups de braços
| Braç | Intervenció / tractament |
|---|---|
| Experimental: Cannabis Medium dose THC, single administration, vaporized | Drug: Cannabis vaporized plant material |
| Active Comparator: Oxycodone 5-10 mg oxycodone hydrochloride, single administration, oral | Drug: Oxycodone oral capsule |
| Placebo Comparator: Placebo No active study drug |
Criteris d'elegibilitat
| Edats elegibles per estudiar | 21 Years Per a 21 Years |
| Sexes elegibles per estudiar | All |
| Accepta voluntaris saludables | Sí |
| Criteris | 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) |
Resultat
Mesures de resultats primaris
1. Pain Numeric Rating Scale (NRS) score (Spine Patients) [3 hours]
2. Pain Threshold (kPa) (Healthy Controls) [3 hours]
Mesures de resultats secundaris
1. Patient Global Impression of Change score [3 hours]
2. Drug effect rating [3 hours]
3. Psychoactive effect rating [3 hours]
4. Mood rating [3 hours]
5. Symbol Digit Modalities Test (SDMT) [3 hours]
6. Hopkins Verbal Learning Test Revised (HVLT) [3 hours]
7. Standardized Field Sobriety Test [3 hours]
