Dronabinol Opioid Sparing Evaluation (DOSE) Trial

• Status: Unknown status
• Trial end date: 2019-07-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Daisy Pharma Opioid Venture, LLC
• Treatments: Analgesics, Opioid; Dronabinol

Criteria

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)