Marijuana in Combination With Opioids in Palliative and Hospice Patients

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03233633
• Other study ID #: WIRB Protocol 20161880-1167645
• Status: Completed
• Phase: Phase 1
• Start date: May 10, 2017
• Est. completion date: August 5, 2022

Study information

• Verified date: September 2022
• Source: The Connecticut Hospice Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: August 5, 2022
• Est. primary completion date: August 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Marijuana Abuse
• Pain

Intervention

Drug:
• Medical Marijuana
oral capsule, high ratio CBD:THC

Locations

Country	Name	City	State
United States	The Connecticut Hospice Inc.	Branford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
The Connecticut Hospice Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	primary reduction of pain and reduction in overall opioid utilization	numeric pain scale	minumum 5 days
Secondary	improvement in overall patient well being	modified Edmonton Assessment Scale	minimum 5 days
Secondary	weight stabilization with increased appetite	modified Edmonton Assessment Scale	minimum 5 days
Secondary	improved oxygen saturation	modified Edmonton Assessment Scale	minimum 5 days
Secondary	improvement or prevention of nausea and vomiting	modified Edmonton Assessment Scale	minimum 5 days