Phase 1
N=66
Marijuana in Combination With Opioids in Palliative and Hospice Patients
Pain
Bottom Line
View on ClinicalTrials.gov: NCT03233633 ↗Enrolled (actual)
66
Serious AEs
1.5%
Results posted
Nov 2024
Primary outcome: Primary: Primary Reduction of Pain — 2.55; 1.40 units on a scale from 0 to 10
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Medical Marijuana (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Connecticut Hospice Inc.
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Reduction of Pain |
2.55; 1.40 | — |
| PRIMARY Reduction in Overall Opioid Utilization |
309.84; 285.54 | — |
| SECONDARY Improvement in Overall Patient Well Being |
3.31; 2.42 | — |
| SECONDARY Weight Stabilization With Increased Appetite |
1.93; 1.70 | — |
| SECONDARY Improved Oxygen Saturation |
94.86; 94.10 | — |
| SECONDARY Reduction or Prevention of Nausea and Vomiting |
0.46; 0.17 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03233633). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.