Marijuana in Combination With Opioids in Palliative and Hospice Patients
Ključne riječi
Sažetak
Opis
Primary Endpoint: Death or discharge
Secondary and Exploratory endpoints:Secondary improvement in overall patient well being, weight stabilization with increased appetite, improved oxygen saturation, improvement or prevention of nausea and vomiting.
Study design: This will be an open-label study. Patients will choose to participate in a Marijuana adjuvant treatment group, receiving marijuana in combination with standard opioid therapy.
Subject number: Minimum 66 patients
Treatment Duration: Minimum 5 days
Duration of follow up: Patients' initial opioid dose, dosing schedule and numeric pain score will be recorded. For the duration of the study (at least five days) changes in opioid doses and numeric pain scores will be tracked daily.
Marijuana will be administered to the patient via oral route three times daily for at least five days. Patients will receive standardized CBD:THC product provided by NIDA.
On admission to the study, a modified Edmonton Symptom assessment scale to quantify baseline appetite, depression, nausea, vomiting, overall well-being, and anxiety.
Data Tracking: Primary objective tracking will include average numeric pain scores and number of opioid dosage increases and average daily opioid amount (mg equivalents of morphine). Secondary objectives include Weight, Appetite, N/V, O2 Saturation, Self-reported data points from the modified Edmonton Assessment Scale.
Datumi
| Posljednja provjera: | 07/31/2017 |
| Prvo podneseno: | 07/25/2017 |
| Predviđena prijava poslana: | 07/26/2017 |
| Prvo objavljeno: | 07/27/2017 |
| Posljednje ažuriranje poslano: | 08/28/2017 |
| Posljednje ažuriranje objavljeno: | 08/30/2017 |
| Stvarni datum početka studija: | 05/09/2017 |
| Procijenjeni datum primarnog završetka: | 07/31/2018 |
| Procijenjeni datum završetka studije: | 08/31/2018 |
Stanje ili bolest
Intervencija / liječenje
Drug: Single treatment arm
Faza
Grupe ruku
| Ruka | Intervencija / liječenje |
|---|---|
| Other: Single treatment arm marijuana adjuvant treatment group utilizing scheduled opioid therapy in inpatient hospice hospital setting | Drug: Single treatment arm oral capsule, high ratio CBD:THC |
Kriterij prihvatljivosti
| Dobni uvjeti za studiranje | 18 Years Do 18 Years |
| Spolovi koji ispunjavaju uvjete za studij | All |
| Prihvaća zdrave volontere | Da |
| Kriteriji | Inclusion Criteria: - Age > 18 - Alert adults - requiring opioids for pain management (routine or as needed) - cancer diagnosis or non-cancer diagnosis as their terminal illness Exclusion Criteria: - pregnant women - Age < 18 - minimally or unresponsive patients unable to take oral medications - agitated combative patients |
Ishod
Primarne mjere ishoda
1. primary reduction of pain and reduction in overall opioid utilization [minumum 5 days]
Sekundarne mjere ishoda
1. improvement in overall patient well being [minimum 5 days]
2. weight stabilization with increased appetite [minimum 5 days]
3. improved oxygen saturation [minimum 5 days]
4. improvement or prevention of nausea and vomiting [minimum 5 days]
