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NCT00153192 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Efficacy of Dronabinol (Marinol) as Add-On Therapy for Patients on Opioids for Chronic Pain
A Phase 2 study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT00153192 is a Phase 2 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 30 participants.
The verdict
NCT00153192, a Phase 2 study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study 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 three 8-hour appointments at Brigham and Women's Hospital. At each 8-hour visit, patients receive a dose of medication and complete surveys relating to pain. During the first visit a brief examination and a few surveys about pain, quality of life, and medical history are given. The study doctor then determines if the participant continues to qualify for the study. If qualified for the study, patients receive a daily diary to record pain levels and pain medications; this will take about 5 minutes each day. After completion of the diary, patients begin the 8-hour visits. Patients visit the Pain Trials Center three times to receive study medication. After taking the study medication, participants remain in the clinic for 8 hours to complete hourly surveys about pain and pain relief. Subsequent to these visits, patients may enter a 1-month extension where Marinol is taken at home, and pain levels are recorded in a diary. Participants can change the dose of study drug to better control pain and side effects, after speaking with study staff. The study then concludes with a final 30-minute visit to summarize the participant's experience in the clinical trial.
Interventions
- DRUG Marinol (dronabinol)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2001-04 |
| Est. Completion | 2006-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00153192
The ClinicalTrials.gov registry entry for NCT00153192 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Marinol (dronabinol) is the first listed.
NCT00153192 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00153192 about?
NCT00153192 is a clinical study titled "Study to Evaluate the Efficacy of Dronabinol (Marinol) as Add-On Therapy for Patients on Opioids for Chronic Pain". 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 three 8-hour appointments at Brigham and Women's Hospital. At each 8-hour visit, patients receive a ...
What is the current status of trial NCT00153192?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2001-04. Estimated completion is 2006-04.
What interventions are being tested in trial NCT00153192?
The interventions under investigation include: Marinol (dronabinol) (DRUG).
Who is sponsoring clinical trial NCT00153192?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
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