Chronic Pain Clinical Trial
Official title:
Dose-Titration Study to Evaluate the Opioid-Sparing Effect of Dronabinol When Coadministered With Opioid Analgesics to Chronic Pain Patients
This study will be a 12-week, open-label trial that is designed to evaluate the Opioid-Sparing effect of Dronabinol at ranging doses when coadministered with the opioid analgesics that are currently being prescribed to patients for their chronic pain condition. The purpose of this trial will be to assess the effectiveness of Dronabinol when combined with opioid analgesics to relieve pain at lower opioid doses and to evaluate any reduction of opioid-related side effects. Participants will take the study-drug, Dronabinol, along with their regular prescribed opioids and the results will be evaluated and analyzed according to defined endpoints.
Week one of the study is a Baseline Period during which time, baseline data related to opioid
dose and frequency, mood, sleep, bowel movements, and pain intensity will be collected.
Participants will receive no Dronabinol during week one and will continue to take their
stabilized dose of regular prescribed opioids, both baseline and rescue.
Weeks two through four is the Titration Period, during which time study participants will
titrate the Dronabinol dose up to a daily dose of 20 mg of Dronabinol per day, according to a
prearranged titration table. Participants will continue to take their stabilized dose of
regular prescribed opioids, both baseline and rescue. Participants will be encouraged to
maintain the 20mg daily total dose of Dronabinol. Participants may also reduce their dose of
Dronabinol at any time (if they experience severe adverse effects) to a minimum daily dose of
Dronabinol of 10mg per day. Participants who cannot tolerate at least a minimum daily dose of
10mg of Dronabinol per day will be discontinued from the study.
Weeks five through twelve is the Opioid-Sparing Period, during which time participants will
be encouraged to maintain the stabilized dose of Dronabinol that they "found" during the
Study-Drug Dose Finding Period. Study Participants will continue to take their regular
prescribed opioids, but will be encouraged to reduce their opioid dose and/or opioid dose
frequency at any time during the remainder of the study should they experience a reduction in
pain and/or an improvement in opioid-related side effects.
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