Dronabinol Opioid Sparing Evaluation (DOSE) Trial

NCT03766269 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: 140635
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (3)

• Pain Intensity Scale (0-10)

  To measure the change in pain intensity from baseline using the Opioid Sparing Diary Toolkit. The measurement of the pain intensity will be derived from the Brief Pain Inventory (Short-Form) item #3. "Please rate your pain by marking the box beside the number that best describes your pain at its worst in the last 24 hours." The score is reported as a value between 0 and 10, with 0 indicative of no pain, and 10 indicative of "pain as bad as you can imagine". The score will be considered a continuous level of measurement.

  Daily (Days 1-82)

• Self-Reported Opioid Use (Opioid Dose)

  To measure the change in opioid dose from baseline using the Opioid Sparing Diary Toolkit

  Daily (Days 1-82)

• Self-Reported Opioid Use Frequency (Opioid Dose Frequency)

  To measure the change in opioid use frequency from baseline using the Opioid Sparing Diary Toolkit

  Daily (Days 1-82)

Secondary Outcomes (16)

• Brief Pain Inventory (BPI)

  Study Visits 1-5 (Days 1, 14, 28, 56, 82)

• Hospital and Anxiety Depression Scale (HADS)

  Study Visits 1-5 (Days 1, 14, 28, 56, 82)

• Side Effect Checklist 29-item

  Study Visits 1-5 (Days 1, 14, 28, 56, 82)

• RAND Health Survey 36-item

  Study Visits 1-5 (Days 1, 14, 28, 56, 82)

• MOS Sleep Scale

  Study Visits 1-5 (Days 1, 14, 28, 56, 82)

Study Arms (1)

Baseline Opioid

OTHER

One of Seven existing Baseline Opioid subgroups (Hydrocodone, Oxycodone, Morphine, Hydromorphone, Buprenorphine, Tramadol) coadministered with intervention drug, Dronabinol.

Drug: Dronabinol

Interventions

Dronabinol DRUG

Dronabinol coadministered with patient's existing Baseline Opioid.

Also known as: Marinol

Baseline Opioid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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)

Sponsors & Collaborators

• Daisy Pharma Opioid Venture, LLC: lead

Study Sites (1)

Daisy Research, Inc.

Scottsdale, Arizona, 85255, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Kendric B Speagle, BA

  Daisy Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kendric B Speagle, BA

CONTACT

4803559000; kendric@daisyrx.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: December 6, 2018
• Study Start: December 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: July 1, 2019
• Last Updated: December 6, 2018

Record last verified: 2018-12

Locations

US (1)