NCT03233633

Marijuana in Combination With Opioids in Palliative and Hospice Patients

Completed Phase 1 Results posted Last updated 6 November 2024

What this trial tests

Phase 1 trial testing Medical Marijuana in Pain in 66 participants. Completed in 5 August 2022.

Timeline

10 May 2017

Primary endpoint
5 August 2022

5 August 2022

Quick facts

Lead sponsor	The Connecticut Hospice Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	66
Start date	10 May 2017
Primary completion	5 August 2022
Estimated completion	5 August 2022
Sites	1 location across United States

Drugs / interventions tested

• Medical Marijuana — full drug profile →

Conditions studied

• Pain — all drugs for Pain →

Sponsor

The Connecticut Hospice Inc.

Who can join

18 and older, any sex, with Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Primary Reduction of Pain Primary · 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.

Pain level at baseline

Group	Value	95% CI
Single Treatment Arm	2.55	± 2.46

Pain level on the last day of study

Group	Value	95% CI
Single Treatment Arm	1.40	± 2.17

Reduction in Overall Opioid Utilization Primary · 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.

Opiates administered at Baseline

Group	Value	95% CI
Single Treatment Arm	309.84	± 775.62

Opiates administered at the end of study

Group	Value	95% CI
Single Treatment Arm	285.54	± 430.76

Improvement in Overall Patient Well Being Secondary · 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.

Overall well-being at Baseline

Group	Value	95% CI
Single Treatment Arm	3.31	± 2.64

Overall well-being at the end of study

Group	Value	95% CI
Single Treatment Arm	2.42	± 2.73

Weight Stabilization With Increased Appetite Secondary · 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.

Appetite at Baseline

Group	Value	95% CI
Single Treatment Arm	1.93	± 1.01

Appetite at the end of study

Group	Value	95% CI
Single Treatment Arm	1.70	± 1.07

Improved Oxygen Saturation Secondary · minimum 3 days

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

O2 Saturation at Baseline

Group	Value	95% CI
Single Treatment Arm	94.86	± 2.53

O2 Saturation at the end of study

Group	Value	95% CI
Single Treatment Arm	94.10	± 2.55

Reduction or Prevention of Nausea and Vomiting Secondary · 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).

Nausea at Baseline

Group	Value	95% CI
Single Treatment Arm	0.46	± 1.33

Nausea at the end of study

Group	Value	95% CI
Single Treatment Arm	0.17	± 0.74

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data was collected from the entire duration for which each patient was enrolled in the study (minimum of 3 days).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Medical Marijuana Treatment Arm

Serious: 1/66 (2%)

Deaths: 66/66

Serious adverse events (1 terms)

Reaction	System	Medical Marijuana Treatmen…
Panic Attack	Psychiatric disorders	—

Other adverse events (1 terms — click to expand)

Reaction	System	Medical Marijuana Treatmen…
Dizziness	General disorders	—

Most-reported serious reactions: Panic Attack.

Data from ClinicalTrials.gov NCT03233633 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Exploring the therapeutic potential of cannabidiol in soft tissue wound healing: Delivery strategies and anti-inflammatory pathways.
   Dubnika A, Jurgelane I, Grava-Ceplite A, Tornaci S, et al · · 2026 · cited 1× · PMID 42039297 · DOI 10.1016/j.apsb.2025.10.001