- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03233633
Marijuana in Combination With Opioids in Palliative and Hospice Patients
Marijuana in Combination With Opioids for Pain and Symptom Control in Hospice Patients
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.
Study Overview
Detailed Description
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
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Connecticut
-
Branford, Connecticut, United States, 06405
- The Connecticut Hospice Inc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Single treatment arm
marijuana adjuvant treatment group utilizing scheduled opioid therapy in inpatient hospice hospital setting
|
oral capsule, high ratio CBD:THC
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
primary reduction of pain and reduction in overall opioid utilization
Time Frame: minumum 5 days
|
numeric pain scale
|
minumum 5 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
improvement in overall patient well being
Time Frame: minimum 5 days
|
modified Edmonton Assessment Scale
|
minimum 5 days
|
weight stabilization with increased appetite
Time Frame: minimum 5 days
|
modified Edmonton Assessment Scale
|
minimum 5 days
|
improved oxygen saturation
Time Frame: minimum 5 days
|
modified Edmonton Assessment Scale
|
minimum 5 days
|
improvement or prevention of nausea and vomiting
Time Frame: minimum 5 days
|
modified Edmonton Assessment Scale
|
minimum 5 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Theodore Zanker, MD, The Connecticut Hospice Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- WIRB Protocol 20161880-1167645
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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