Trial | NCT03233633  Report issue

Title

Marijuana in Combination With Opioids in Palliative and Hospice Patients
Marijuana in Combination With Opioids for Pain and Symptom Control in Hospice Patients

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Indication/Condition

    Pain

  • Study Participants

    66
Study Objectives: Primary reduction of pain and reduction in overall opioid utilization. Secondary improvement in overall patient well being, weight stabilization with increased appetite, improved oxygen saturation, improvement or prevention of nausea and vomiting.

Study Rationale: To determine optimum use and dosing of medical marijuana (CBD:THC) for pain and symptom management.

Study Population: This study specifically will enroll cancer and non-cancer patients as a primary diagnosis suffering from pain and having a terminal illness (defined as having less than 6 months to live) requiring end of life care.
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.
Study Started
May 10
2017
Primary Completion
Aug 05
2022
Study Completion
Aug 05
2022
Last Update
Sep 02
2022

Drug Medical Marijuana

oral capsule, high ratio CBD:THC

  • Other names: cannabidiol, medical cannabis

Single treatment arm Other

marijuana adjuvant treatment group utilizing scheduled opioid therapy in inpatient hospice hospital setting

Criteria 

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
No Results Posted