Chronic PainPhase 2NCT03766269
Dronabinol Opioid Sparing Evaluation (DOSE) Trial
A Phase 2 study testing Dronabinol in people with Chronic Pain, run by Daisy Pharma Opioid Venture, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Dronabinol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2018to 1 Jul 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
Show all 10Show fewer
- 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;
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Daisy Research, Inc.
Scottsdale, Arizona, 85255
KENDRIC B SPEAGLE, BA, 480-355-9000, kendric@daisyrx.com
Kendric B Speagle, BA
About this study
Official title: Dose-Titration Study to Evaluate the Opioid-Sparing Effect of Dronabinol When Coadministered With Opioid Analgesics to Chronic Pain Patients
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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- Dronabinol
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DronabinolDrug
Also called Marinol
Dronabinol coadministered with patient's existing Baseline Opioid.
| Study group | Role | What they receive |
|---|---|---|
| Baseline Opioid | Other | One of Seven existing Baseline Opioid subgroups (Hydrocodone, Oxycodone, Morphine, Hydromorphone, Buprenorphine, Tramadol) coadministered with intervention drug, Dronabinol. Receives: Drug: Dronabinol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: Daily (Days 1-82)
Secondary outcomes (16)
Brief Pain Inventory (BPI)
To evaluate and measure any changes in pain history, intensity, location, relief, and life interference indicators from baseline
Measured: Study Visits 1-5 (Days 1, 14, 28, 56, 82)
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).
Measured: Study Visits 1-5 (Days 1, 14, 28, 56, 82)
Side Effect Checklist 29-item
To evaluate the presence or absence of side effects associated with the intervention
Measured: Study Visits 1-5 (Days 1, 14, 28, 56, 82)
RAND Health Survey 36-item
To measure the change in overall quality of life from baseline
Measured: Study Visits 1-5 (Days 1, 14, 28, 56, 82)
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.
Measured: Study Visits 1-5 (Days 1, 14, 28, 56, 82)
Treatment Satisfaction Questionnaire for Medication (TSQM)
To measure the change in satisfaction with medication from baseline
Measured: Study Visits 1-5 (Days 1, 14, 28, 56, 82)
Bowel Function Inventory-Revised (BFI-R)
To measure the change in Opioid-Induced Constipation from baseline
Measured: Study Visits 1-5 (Days 1, 14, 28, 56, 82)
Current Opioid Misuse Measure (COMM)
To measure the change in Possible Opioid Misuse from baseline
Measured: Study Visits 1-5 (Days 1, 14, 28, 56, 82)
Numerical Opioid Side Effect (NOSE) Assessment
To measure the change in Opioid Side Effect Severity from baseline
Measured: Study Visits 1-5 (Days 1, 14, 28, 56, 82)
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.
Measured: Daily (Days 1-82)
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.
Measured: Daily (Days 1-82)
OSD: Bowel Movement 24-Hour Self Report Survey
To measure the change in number of Bowel Movements from baseline
Measured: Daily (Days 1-82)
FITBIT: Sleep Tracker
To measure the change in quantity and quality of sleep from baseline
Measured: Daily (Days 1-82)
FITBIT: Distance Tracker
To measure the change in average weekly distance traveled from baseline
Measured: Daily (Days 1-82)
FITBIT: Caloric Expenditure Tracker
To measure the change in average weekly calories expended from baseline
Measured: Daily (Days 1-82)
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)
Measured: Study Visits 1 & 5 (Days 1 & 82)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start1 Dec 2018
- Primary completion1 Jun 2019 (estimated)
- Study completion1 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daisy Pharma Opioid Venture, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kendric B Speagle, BA, Principal investigator, Daisy Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03766269
- Sponsor's protocol ID
- 140635
- Status last verified
- Dec 2018
- First submitted
- 30 Nov 2018
- Last updated
- 6 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-Titration Study to Evaluate the Opioid-Sparing Effect of Dronabinol When Coadministered With Opioid Analgesics to Chronic Pain Patients
- ClinicalTrials.gov ID
- NCT03766269
- Acronym / sponsor ID
- 140635
- Conditions
- Chronic Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Daisy Pharma Opioid Venture, LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Jun 2019 (estimated)
- Study completion
- 1 Jul 2019 (estimated)
- First posted
- 6 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Baseline Opioid | Other | Drug: DronabinolOne of Seven existing Baseline Opioid subgroups (Hydrocodone, Oxycodone, Morphine, Hydromorphone, Buprenorphine, Tramadol) coadministered with intervention drug, Dronabinol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DronabinolAlso: MarinolDronabinol coadministered with patient's existing Baseline Opioid. | Drug | Baseline Opioid |
Primary outcome
Pain Intensity Scale (0-10)
Time frame: Daily (Days 1-82)
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)
Time frame: Daily (Days 1-82)
To measure the change in opioid dose from baseline using the Opioid Sparing Diary Toolkit
Self-Reported Opioid Use Frequency (Opioid Dose Frequency)
Time frame: Daily (Days 1-82)
To measure the change in opioid use frequency from baseline using the Opioid Sparing Diary Toolkit
16 secondary outcomes
Brief Pain Inventory (BPI)
Time frame: Study Visits 1-5 (Days 1, 14, 28, 56, 82)
Hospital and Anxiety Depression Scale (HADS)
Time frame: Study Visits 1-5 (Days 1, 14, 28, 56, 82)
Side Effect Checklist 29-item
Time frame: Study Visits 1-5 (Days 1, 14, 28, 56, 82)
RAND Health Survey 36-item
Time frame: Study Visits 1-5 (Days 1, 14, 28, 56, 82)
MOS Sleep Scale
Time frame: Study Visits 1-5 (Days 1, 14, 28, 56, 82)
Treatment Satisfaction Questionnaire for Medication (TSQM)
Time frame: Study Visits 1-5 (Days 1, 14, 28, 56, 82)
Bowel Function Inventory-Revised (BFI-R)
Time frame: Study Visits 1-5 (Days 1, 14, 28, 56, 82)
Current Opioid Misuse Measure (COMM)
Time frame: Study Visits 1-5 (Days 1, 14, 28, 56, 82)
Numerical Opioid Side Effect (NOSE) Assessment
Time frame: Study Visits 1-5 (Days 1, 14, 28, 56, 82)
OSD: Mood Scale Self Report (0-10)
Time frame: Daily (Days 1-82)
OSD: Sleep Scale Self Report (0-10)
Time frame: Daily (Days 1-82)
OSD: Bowel Movement 24-Hour Self Report Survey
Time frame: Daily (Days 1-82)
FITBIT: Sleep Tracker
Time frame: Daily (Days 1-82)
FITBIT: Distance Tracker
Time frame: Daily (Days 1-82)
FITBIT: Caloric Expenditure Tracker
Time frame: Daily (Days 1-82)
Medical Billing Claims Data for each participant
Time frame: Study Visits 1 & 5 (Days 1 & 82)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kendric B Speagle, BA principal investigator
Daisy Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dronabinol in people with Chronic Pain, run by Daisy Pharma Opioid Venture, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kendric B Speagle, BA (4803559000, kendric@daisyrx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity Scale (0-10) (time frame: Daily (Days 1-82)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2018.