Clinical trial NCT03233633: Marijuana in Combination With Opioids in Palliative and Hospice Patients
Official title: Marijuana in Combination With Opioids for Pain and Symptom Control in Hospice Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Keywords: pain management
terminally ill
Lead sponsor: The Connecticut Hospice Inc.
Sponsor class: OTHER
First posted: 2017-07-28
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: Primary Endpoint: Primary reduction of pain and reduction in overall opioid utilization as evidenced by overall reduction in numeric pain scores and MME (Morphine Milliequivalents)

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. Endpoints evaluation will be based on change from Baseline using the Modified Edmonton Assessment Scale.

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.

Eligibility criteria: Inclusion Criteria:

* Age \> 18
* Alert adults
* requiring opioids for pain management (routine)
* 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

Primary outcomes:
measure: Primary Reduction of Pain
timeFrame: minumum 3 days
measure: Reduction in Overall Opioid Utilization
timeFrame: minimum of 3 days
Secondary outcomes:
measure: Improvement in Overall Patient Well Being
timeFrame: minimum 3 days
measure: Weight Stabilization With Increased Appetite
timeFrame: minimum 3 days
measure: Improved Oxygen Saturation
timeFrame: minimum 3 days
measure: Reduction or Prevention of Nausea and Vomiting
timeFrame: minimum 3 days
Other outcomes:
Locations:
city: Branford
country: United States
facility: The Connecticut Hospice Inc.
state: Connecticut
Study officials:
affiliation: The Connecticut Hospice Inc.
name: Theodore Zanker, MD
role: PRINCIPAL_INVESTIGATOR
References: