Marijuana in Combination With Opioids in Palliative and Hospice Patients

NCT ID: NCT03233633

Last Updated: 2024-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-10
• Study Completion Date: 2022-08-05

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.

Conditions

Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Single treatment arm

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

Group Type: OTHER

Medical Marijuana

Intervention Type: DRUG

oral capsule, high ratio CBD:THC

Interventions

Medical Marijuana

oral capsule, high ratio CBD:THC

Intervention Type: DRUG

Other Intervention Names

cannabidiol; medical cannabis

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Connecticut Hospice Inc.

OTHER

Sponsor Role: lead

Responsible Party

Theodore Zanker MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Theodore Zanker, MD

Role: PRINCIPAL_INVESTIGATOR

The Connecticut Hospice Inc.

Locations

The Connecticut Hospice Inc.

Branford, Connecticut, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

WIRB Protocol 20161880-1167645

Identifier Type: -

Identifier Source: org_study_id