DronabinolDronabinol Opioid Sparing Evaluation (DOSE) Trial

Inclusion Criteria:

1. Ability to read, speak, and understand English;
2. Provision of signed and dated informed consent form;
3. Stated willingness to comply with all study procedures and availability for the duration of the study;
4. Male, Female, or Transgender aged > 18;
5. In fair and stable general health as evidenced by medical history and physical examination, and confirmed by prescriber;
6. Participants who have been diagnosed with a pain condition that has not adequately responded to other treatments, in the judgement of the provider;
7. 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.;
8. Ability to take medications as prescribed and willingness to adhere to the study-drug regimen;
9. 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;
10. Agreement to abstain from the use of cannabis or other cannabinoid compounds, other than the study-drug Dronabinol, throughout study duration;

Exclusion Criteria:

1. Current substance abuse by self-report;
2. Current use of cannabis or other cannabinoid compounds;
3. Significant baseline nausea, vomiting, sedation, or other symptoms reported by physician and or patient that may compromise the collection of study-related data;
4. A history of seizures, head trauma, and or mental illness ;
5. Pregnancy or lactation;
6. Known allergic reactions to components of Dronabinol;
7. 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)