Marijuana in Combination With Opioids in Palliative and Hospice Patients
Raktažodžiai
Santrauka
apibūdinimas
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.
Datos
| Paskutinį kartą patikrinta: | 07/31/2017 |
| Pirmasis pateikimas: | 07/25/2017 |
| Numatytas registravimas pateiktas: | 07/26/2017 |
| Pirmas paskelbtas: | 07/27/2017 |
| Paskutinis atnaujinimas pateiktas: | 08/28/2017 |
| Paskutinis atnaujinimas paskelbtas: | 08/30/2017 |
| Faktinė studijų pradžios data: | 05/09/2017 |
| Numatoma pirminio užbaigimo data: | 07/31/2018 |
| Numatoma studijų užbaigimo data: | 08/31/2018 |
Būklė ar liga
Intervencija / gydymas
Drug: Single treatment arm
Fazė
Rankų grupės
| Ranka | Intervencija / gydymas |
|---|---|
| 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 |
Tinkamumo kriterijai
| Amžius, tinkami studijuoti | 18 Years Į 18 Years |
| Tinkamos studijoms lytys | All |
| Priima sveikus savanorius | Taip |
| Kriterijai | 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 |
Rezultatas
Pirminės rezultatų priemonės
1. primary reduction of pain and reduction in overall opioid utilization [minumum 5 days]
Antrinės rezultatų priemonės
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]
