Marijuana in Combination With Opioids in Palliative and Hospice Patients
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|ClinicalTrials.gov Identifier: NCT03233633|
Recruitment Status : Unknown
Verified August 2017 by Theodore Zanker MD, The Connecticut Hospice Inc..
Recruitment status was: Enrolling by invitation
First Posted : July 28, 2017
Last Update Posted : August 31, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Pain Management in Terminally Ill Patients Receiving Scheduled Opioid Therapy||Drug: Medical Marijuana||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||66 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Marijuana in Combination With Opioids for Pain and Symptom Control in Hospice Patients|
|Actual Study Start Date :||May 10, 2017|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||September 2018|
Single treatment arm
marijuana adjuvant treatment group utilizing scheduled opioid therapy in inpatient hospice hospital setting
Drug: Medical Marijuana
oral capsule, high ratio CBD:THC
- primary reduction of pain and reduction in overall opioid utilization [ Time Frame: minumum 5 days ]numeric pain scale
- improvement in overall patient well being [ Time Frame: minimum 5 days ]modified Edmonton Assessment Scale
- weight stabilization with increased appetite [ Time Frame: minimum 5 days ]modified Edmonton Assessment Scale
- improved oxygen saturation [ Time Frame: minimum 5 days ]modified Edmonton Assessment Scale
- improvement or prevention of nausea and vomiting [ Time Frame: minimum 5 days ]modified Edmonton Assessment Scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03233633
|United States, Connecticut|
|The Connecticut Hospice Inc.|
|Branford, Connecticut, United States, 06405|
|Principal Investigator:||Theodore Zanker, MD||The Connecticut Hospice Inc.|