Cannabis Versus Oxycodone for Pain Relief
Nyckelord
Abstrakt
Beskrivning
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.
Datum
| Senast verifierad: | 06/30/2020 |
| Först skickat: | 09/01/2016 |
| Beräknad anmälan inlämnad: | 09/01/2016 |
| Först publicerad: | 09/07/2016 |
| Senaste uppdatering skickad: | 07/06/2020 |
| Senaste uppdatering publicerad: | 07/08/2020 |
| Faktiskt startdatum för studien: | 05/31/2017 |
| Uppskattat primärt slutdatum: | 12/31/2020 |
| Beräknat slutfört datum: | 12/31/2020 |
Tillstånd eller sjukdom
Intervention / behandling
Drug: Cannabis
Drug: Oxycodone
Drug: Placebo for Cannabis
Drug: Placebo for Oxycodone
Fas
Armgrupper
| Ärm | Intervention / behandling |
|---|---|
| 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 |
Urvalskriterier
| Åldrar berättigade till studier | 21 Years Till 21 Years |
| Kön som är berättigade till studier | All |
| Accepterar friska volontärer | Ja |
| Kriterier | 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
Primära resultatåtgärder
1. Pain Numeric Rating Scale (NRS) score (Spine Patients) [3 hours]
2. Pain Threshold (kPa) (Healthy Controls) [3 hours]
Sekundära resultatåtgärder
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]
