Marijuana in Combination With Opioids in Palliative and Hospice Patients

NCT03233633 | Completed Phase 1 Results FDA Drug

• 1 other identifier: WIRB Protocol 20161880-1167645
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

pain management; terminally ill

Outcome Measures

Primary Outcomes (2)

• Primary Reduction of Pain

  A numeric pain scale (Units on a scale with the higher number indicating worse pain) was used to assess pain from a range of 0 to 10.

  minumum 3 days

• Reduction in Overall Opioid Utilization

  Reduction in overall opioid utilization was measured in units of mg after converting every patient's opioids into equivalent doses (e.g. 2mg of oral dilaudid = 1/4 oral morphine), with a stabilization or reduction in Morphine Mg Equivalents indicating a positive result.

  minimum of 3 days

Secondary Outcomes (4)

• Improvement in Overall Patient Well Being

  minimum 3 days

• Weight Stabilization With Increased Appetite

  minimum 3 days

• Improved Oxygen Saturation

  minimum 3 days

• Reduction or Prevention of Nausea and Vomiting

  minimum 3 days

Study Arms (1)

Single treatment arm

OTHER

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

Drug: Medical Marijuana

Interventions

Medical Marijuana DRUG

oral capsule, high ratio CBD:THC

Also known as: cannabidiol, medical cannabis

Single treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18
• Alert adults
• requiring opioids for pain management (routine)
• cancer diagnosis or non-cancer diagnosis as their terminal illness

You may not qualify if:

• pregnant women
• Age \< 18
• minimally or unresponsive patients unable to take oral medications
• agitated combative patients

Sponsors & Collaborators

• The Connecticut Hospice Inc.: lead

Study Sites (1)

The Connecticut Hospice Inc.

Branford, Connecticut, 06405, United States

Location

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Medical Marijuana; Cannabidiol

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Limitations and Caveats

1. This is a single-arm study with only an intervention arm and no control. As a result, it is not possible to draw any causal conclusions. Follow-up studies are needed to further validate the preliminary signals and patterns observed in this study. 2. There were three patients who experienced a dose change in marijuana from 40mg to 80mg CBD. 3. Some outcome measurements were missing due to the inability of patients to respond to questions.

Results Point of Contact

• Title: Jim Prota, Director of Pharmacy
• Organization: Connecticut Hospice

jprota@hospice.com

203-848-0660

Study Officials

• Theodore Zanker, MD

  The Connecticut Hospice Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 26, 2017
• First Posted: July 28, 2017
• Study Start: May 10, 2017
• Primary Completion: August 5, 2022
• Study Completion: August 5, 2022
• Last Updated: November 6, 2024
• Results First Posted: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)