Status:
UNKNOWN
Dronabinol Opioid Sparing Evaluation (DOSE) Trial
Lead Sponsor:
Daisy Pharma Opioid Venture, LLC
Conditions:
Chronic Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 b...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Ability to read, speak, and understand English;
- Provision of signed and dated informed consent form;
- Stated willingness to comply with all study procedures and availability for the duration of the study;
- Male, Female, or Transgender aged \> 18;
- In fair and stable general health as evidenced by medical history and physical examination, and confirmed by prescriber;
- Participants who have been diagnosed with a pain condition that has not adequately responded to other treatments, in the judgement of the provider;
- Participants who are currently taking a stabilized dose of opioid analgesics, and who have been taking opioid analgesics for at least 3-months, and who report a score of \> 3 on the Brief Pain Inventory 0-10 severity index.;
- Ability to take medications as prescribed and willingness to adhere to the study-drug regimen;
- For females of reproductive potential: use of highly effective contraception for at least 1 month prior to enrollment and agreement to use such a method during study participation;
- Agreement to abstain from the use of cannabis or other cannabinoid compounds, other than the study-drug Dronabinol, throughout study duration;
Exclusion
- Current substance abuse by self-report;
- Current use of cannabis or other cannabinoid compounds;
- Significant baseline nausea, vomiting, sedation, or other symptoms reported by physician and or patient that may compromise the collection of study-related data;
- A history of seizures, head trauma, and or mental illness ;
- Pregnancy or lactation;
- Known allergic reactions to components of Dronabinol;
- Taking any of the following drugs:
- Strong CYP2C9 Inhibitor (e.g., amiodarone, fluconazole) Strong CYP3A4 Inhibitor (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, erythromycin) Potent CYP2C9 or CYP3A4 inducers (e.g., rifampicin) Drugs that are highly protein-bound (e.g., warfarin, cyclosporine, amphotericin B)
Key Trial Info
Start Date :
December 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2019
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT03766269
Start Date
December 1 2018
End Date
July 1 2019
Last Update
December 6 2018
Active Locations (1)
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1
Daisy Research, Inc.
Scottsdale, Arizona, United States, 85255