Status:
COMPLETED
Study to Evaluate the Efficacy of Dronabinol (Marinol) as Add-On Therapy for Patients on Opioids for Chronic Pain
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Solvay Pharmaceuticals
Conditions:
Chronic Pain
Eligibility:
All Genders
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this research study is to determine if Marinol alleviates pain in patients with chronic pain who are currently taking opioids. The study begins with a 2-hour initial visit followed by ...
Detailed Description
During the informed consent process subjects will be informed that Marinol (Dronabinol) is generally not used for chronic pain and there will be no provision for extended treatment with Dronabinol. T...
Eligibility Criteria
Inclusion
- Chronic somatic nociceptive pain syndromes\*, with a minimum pain score on average of 4/10
- Stable doses of opioid analgesics per investigator judgment
- Negative urine pregnancy test in all females with reproductive capacity
- Patients agree to use adequate birth control measures during the study
- (\*including but not limited to, musculoskeletal pain, neck pain, low back pain, pain due to osteoarthritis, fibromyalgia, failed back surgery syndrome etc.)
Exclusion
- Current substance abuse by self-report.
- Chronic pain due to cancer
- Any marijuana use within three months by self-report
- Active litigation, compensation, or disability issues
- Significant baseline nausea, vomiting, sedation, or other symptoms that may compromise the collection of study-related data
- Patients on a baseline opioid regimen that requires opioid dosing more frequently than every 8 hours
- Unstable psychiatric disorders per investigator judgment
- Baseline Beck depression inventory indicating moderate or greater depression, or active suicidality
- Baseline anxiety inventory indicating moderate or greater anxiety
- Patient feels unable to defer morning opioid dose until arrival in the study center
- Patients using Duragesic patch
- Patients receiving opioids via an implanted intrathecal pump
Key Trial Info
Start Date :
April 1 2001
Trial Type :
INTERVENTIONAL
End Date :
April 1 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00153192
Start Date
April 1 2001
End Date
April 1 2006
Last Update
April 26 2013
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115