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Completed

NCT Number: NCT03233633

Marijuana in Combination With Opioids in Palliative and 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Connecticut Hospice Inc.

Branford, Connecticut, 06405, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medical Marijuana

Drug

oral capsule, high ratio CBD:THC

Other names: cannabidiol, medical cannabis

Primary outcomes

  1. Primary Reduction of Pain

    Time frame: minumum 3 days

    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.

  2. Reduction in Overall Opioid Utilization

    Time frame: minimum of 3 days

    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.

Secondary outcomes

  1. Improvement in Overall Patient Well Being

    Time frame: minimum 3 days

    A modified Edmonton Assessment Scale was used. The Edmonton Symptom Assessment System (ESAS) is a questionnaire used to rate the intensity of common symptoms experienced by cancer patients, including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and shortness of breath. A scale of 1 to 10 was used, where, 1 corresponds to the best well-being and 10 corresponds to the worst well-being.

  2. Weight Stabilization With Increased Appetite

    Time frame: minimum 3 days

    A modified Edmonton Assessment Scale was used. The Edmonton Symptom Assessment System (ESAS) is a questionnaire used to rate the intensity of common symptoms experienced by cancer patients, including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and shortness of breath.

    Appetite was analyzed as an ordinal variable where 1 = finished 0~25% of meal, 2 = 25~50% of meal, 3 = 50~75% of meal, 4 = 75~100% of meal.

  3. Improved Oxygen Saturation

    Time frame: minimum 3 days

    Oxygen saturation was reported as a percentage, the greater the % O2 saturation the more positive the outcome.

  4. Reduction or Prevention of Nausea and Vomiting

    Time frame: minimum 3 days

    A modified Edmonton Assessment Scale was used; the scale is a numeric 0-10 scale (Units on a scale where the higher the number the more nausea and vomiting the patient experienced).

Sponsors and collaborators

Lead sponsor

The Connecticut Hospice Inc.

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Jul 28, 2017
Registry last updated
Nov 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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