Inhaled Synthetic Cannabinoids Versus Immediate-release Oral Opioids for the Management of Breakthrough Cancer Pain (REBORN)
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ClinicalTrials.gov Identifier: NCT03564548 |
Recruitment Status :
Suspended
(postponed later)
First Posted : June 21, 2018
Last Update Posted : March 18, 2020
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Condition or disease | Intervention/treatment | Phase |
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Cancer Breakthrough Cancer Pain | Drug: PPP011 Drug: Morphine sulfate | Phase 2 |
This is a pilot study that will be conducted at the Hassman Research Institute. It consists of two sub-studies; Sub-study A will be completed and analyzed prior to starting Sub-study B:
- Sub-study A is an open-label crossover comparison study: This will be a 12-week open-label randomized study to evaluate the effect of inhaled PPP011 as compared to morphine sulfate to improve fast onset of pain relief of BTcP. After proper screening and verified inclusion/exclusion criteria, 20 consecutive subjects will be recruited to participate in Sub-study A.
- Sub-study B is a randomized double-blind placebo-controlled trial: This will be a 7-week study to evaluate the effect of inhaled PPP011 or morphine sulfate to improve onset of pain relief when compared to placebo in subjects with BTcP. After proper screening and verified inclusion/exclusion criteria, 40 consecutive subjects will be recruited prospectively to participate in this trial. The same inclusion/exclusion criteria of the open-label study will be applied. The subjects recruited for this study will be different from those recruited for the open-label study.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | The first part of the study will be in a crossover model and the second part in a parallel model |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Inhaled PPP011 Versus Immediate-release Oral Opioids for the Management of Breakthrough Pain in Cancer Subjects: an Open Label, Crossover, Comparison Study Followed by a Randomized, Double-blind, Placebo-controlled Pilot Trial |
Estimated Study Start Date : | September 1, 2020 |
Estimated Primary Completion Date : | February 28, 2021 |
Estimated Study Completion Date : | April 30, 2022 |

Arm | Intervention/treatment |
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Experimental: CAUMZ PPP011
Inhaled synthetic cannabinoids (PPP011)
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Drug: PPP011
Group assigned to PPP001 during the open-label |
Active Comparator: Morphine sulfate
Oral morphine sulfate at the previous stabilized dosage
|
Drug: Morphine sulfate
Group assigned to morphine sulfate during the open-label |
- Pain unpleasantness difference (PUD) at BTcP onset [ Time Frame: change between 0 min (before starting treatment) and 10 minutes after BTcP onset based on the VAS score ]PU score after PPP011 administration on request and/or morphine sulfate administration on request. PUD is assessed after BTcP onset during the 2 weeks of PPP011 chronic treatment.
- Pain unpleasantness difference (PUD) at BTcP onset [ Time Frame: change between 0 min (before starting treatment) and 30 minutes after BTcP onset based on the VAS score ]PU score after PPP011 administration on request and/or morphine sulfate administration on request. PUD is assessed after BTcP onset during the 2 weeks of PPP011 chronic treatment.
- Pain unpleasantness difference (PUD) at BTcP onset [ Time Frame: change between 0 min (before starting treatment) and 60 minutes after BTcP onset based on the VAS score ]PU score after PPP011 administration on request and/or morphine sulfate administration on request. PUD is assessed after BTcP onset during the 2 weeks of PPP011 chronic treatment.
- The sum of pain unpleasantness differences (SPUD) that equals to the area under the curve for PUD/time interval in minutes [ Time Frame: This will be measured for the 0-30 minutes interval (SPUD0-30) and the 0-60 minutes interval (SPUD0-60). SPUD is assessed after BTcP onset during the 2 weeks of PPP011 chronic treatment. ]
- measurement of Pain Unpleasantness (PU) relief [ Time Frame: VAS will be completed at 0 min (immediately after BTcP onset, before treatment administration), and 10 ±2 min, 30 ±2 min and 60 ±2 minutes after PPP011 or morphine sulfate administration ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Written informed consent.
- Adult male and female subjects at least 18 years of age.
- Subject agrees to follow the protocol.
- Confirmed diagnosis of cancer with life expectancy of more than 3 months; Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
- If currently receiving chemotherapy and/or radiotherapy treatment, subjects must be on a stable regimen for at least one month (30 days ± 2 days) prior to screening.
- Background cancer pain stable (pain <4/10 on numeric rating scale) and adequately controlled with long-acting oral morphine, oxycodone, hydromorphone, hydrocodone, or meperidine.
- Subject receiving at least 30 mg of oral morphine equivalent daily doses (MEDD) for both background and breakthrough cancer pain.
- The subject is currently taking chronic treatment with opiod analgesic but still has a clinical diagnosis of breakthrough cancer pain with <3 episodes per day but >3 episodes per week.
- The subject is using only oral morphine sulfate for breakthrough opioid analgesia.
- Normal cognitive status according to MiniCog.
- The subject is able to perform deep inhalations with FEV1 more than 60%.
- Ability to read and respond to questions in English.
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A female subject must meet one of the following criteria:
If of childbearing potential - agrees to use one of the accepted contraceptive regimens from at least 28 days prior to the first drug administration, during the study and for at least 60 days after the last dose.
If of non-childbearing potential - should be surgically sterile or in a menopausal state
- A male subject with sexual partners who are pregnant, possibly pregnant, or who could become pregnant must be surgically sterile or agrees to use one of the accepted contraceptive regimens from first drug administration until 3 months after the last drug administration.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03564548
United States, New Jersey | |
HRI | |
Berlin, New Jersey, United States, 08009 |
Principal Investigator: | Mitchell Hassman | Hassman Research Institute |
Responsible Party: | Tetra Bio-Pharma |
ClinicalTrials.gov Identifier: | NCT03564548 |
Other Study ID Numbers: |
PPP011-Ph2-02 |
First Posted: | June 21, 2018 Key Record Dates |
Last Update Posted: | March 18, 2020 |
Last Verified: | March 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Cancer Pain Pain Neurologic Manifestations Morphine Analgesics, Opioid Narcotics |
Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents |