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Dronabinol Opioid Sparing Evaluation (DOSE) Trial

Primary Purpose

Chronic Pain

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Dronabinol

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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 Criteria:

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)

Sites / Locations

Daisy Research, Inc.Recruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Baseline Opioid

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Self-Reported Opioid Use (Opioid Dose)

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

Self-Reported Opioid Use Frequency (Opioid Dose Frequency)

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

Secondary Outcome Measures

Brief Pain Inventory (BPI)

To evaluate and measure any changes in pain history, intensity, location, relief, and life interference indicators from baseline

Hospital and Anxiety Depression Scale (HADS)

To measure the change in depression and generalized anxiety from baseline. The HADS measures levels of anxiety and depression that a patient is experiencing. The HADS is a fourteen item scale. Seven of the items relate to a factor that measures anxiety and seven relate to a factor that measures depression. The seven items for each factor are summed into a total score and range from 0 to 21, with higher scores indicative of greater anxiety/depression. The scores will be analyzed as continuous level variables and one-sided paired-samples t-tests will be used to compare mean scores for anxiety and depression for all subjects between Week 1 (baseline) and Week 12 (EOS).

Side Effect Checklist 29-item

To evaluate the presence or absence of side effects associated with the intervention

RAND Health Survey 36-item

To measure the change in overall quality of life from baseline

MOS Sleep Scale

To measure the change in quality of sleep from baseline. The MOS Sleep Scale Self Report includes 12 items which measure 7 individual continuous-level factors relating to sleep quality: (a) sleep disturbances, (b) snoring, (c) sleep short of breath or headache, (d) sleep adequacy, (e) sleep somnolence, (f) sleep problems index I, and (g) sleep problems index II. Each of the seven factors is scored via a two-step process such that higher resulting scores are indicative of greater sleep problems. All 7 scores are measured at the continuous level.

Treatment Satisfaction Questionnaire for Medication (TSQM)

To measure the change in satisfaction with medication from baseline

Bowel Function Inventory-Revised (BFI-R)

To measure the change in Opioid-Induced Constipation from baseline

Current Opioid Misuse Measure (COMM)

To measure the change in Possible Opioid Misuse from baseline

Numerical Opioid Side Effect (NOSE) Assessment

To measure the change in Opioid Side Effect Severity from baseline

OSD: Mood Scale Self Report (0-10)

To measure the change in Mood from baseline. The Mood Scale is a 10 item Likert-scaled instrument with each of the 10 items scored from 1 = absolutely miserable to 10 = absolutely happy. The scores for each of the 10 items will be summed into a mood total score. The mood total score can range from 10 to 100, with higher scores indicative of happier states. The mood total score is a continuous level of measurement.

OSD: Sleep Scale Self Report (0-10)

To measure the change in Quality of Sleep from baseline. The Sleep Scale is a 10 item Likert-scaled instrument with each of the 10 items scored from 1 = worst imaginable to 10 = best . The scores for each of the 10 items will be summed into a sleep total score. The sleep total score can range from 10 to 100, with higher scores indicative of better quality sleep. The sleep total score is a continuous level of measurement.

OSD: Bowel Movement 24-Hour Self Report Survey

To measure the change in number of Bowel Movements from baseline

FITBIT: Sleep Tracker

To measure the change in quantity and quality of sleep from baseline

FITBIT: Distance Tracker

To measure the change in average weekly distance traveled from baseline

FITBIT: Caloric Expenditure Tracker

To measure the change in average weekly calories expended from baseline

Medical Billing Claims Data for each participant

To evaluate the change in Health Care Expenditures Related To Chronic Pain from baseline (average monthly expenditures before study)

Full Information

NCT ID

NCT03766269

First Posted

November 30, 2018

Last Updated

December 4, 2018

Sponsor

Daisy Pharma Opioid Venture, LLC

1. Study Identification

Unique Protocol Identification Number

NCT03766269

Brief Title

Dronabinol Opioid Sparing Evaluation (DOSE) Trial

Official Title

Dose-Titration Study to Evaluate the Opioid-Sparing Effect of Dronabinol When Coadministered With Opioid Analgesics to Chronic Pain Patients

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Unknown status

Study Start Date

December 1, 2018 (Actual)

Primary Completion Date

June 1, 2019 (Anticipated)

Study Completion Date

July 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Daisy Pharma Opioid Venture, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Baseline Opioid

Arm Type

Other

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Dronabinol

Other Intervention Name(s)

Marinol

Intervention Description

Dronabinol coadministered with patient's existing Baseline Opioid.

Primary Outcome Measure Information:

Title

Pain Intensity Scale (0-10)

Description

Time Frame

Daily (Days 1-82)

Title

Self-Reported Opioid Use (Opioid Dose)

Description

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

Time Frame

Daily (Days 1-82)

Title

Self-Reported Opioid Use Frequency (Opioid Dose Frequency)

Description

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

Time Frame

Daily (Days 1-82)

Secondary Outcome Measure Information:

Title

Brief Pain Inventory (BPI)

Description

To evaluate and measure any changes in pain history, intensity, location, relief, and life interference indicators from baseline

Time Frame