Respiratory DepressionPhase 1NCT03996694
Single Dose Crossover Study to Compare the Respiratory Drive After Administration of Belbuca, Oxycodone and Placebo.
A Phase 1 study testing Belbuca 300 µg, Belbuca 600 µg and Belbuca 900 µg in people with Respiratory Depression, run by BioDelivery Sciences International at 1 site in United States.
Trial summary
The purpose of this study is to explore and compare VRH after administration of Belbuca, Oxycodone HCl and Placebo in recreational opioid users. This is a single-center, double -blind, double-dummy , placebo-controlled randomized crossover study in up to 18 men and women self identifying as recreational users. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Depression
- What is being tested?
- Belbuca 300 µg, Belbuca 600 µg and Belbuca 900 µg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2019to 27 Oct 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female subjects 18 to 55 years of age, inclusive.
- Subjects are in good health as indicated by medical history, PE, vital signs, oxygen saturation, clinical laboratory tests, and 12-lead ECG. A status of good health will be defined by the absence of evidence of any clinically significant, active or chronic disease based on these assessments, in the opinion of the investigator.
- Subjects with a body mass index (BMI) of 18.0 to 33.0 kg/m2, inclusive, and body weight greater than 50 kg, inclusive.
- Subject is able to speak, read, and understand English and voluntarily provide written informed consent to participate in the study.
- Subjects have healthy oral mucosa as determined by examination at screening and admission to the clinical facility.
- Subject must be a recreational opioid user who is not currently dependent on opioids (based on self-reported DSM-5 criteria and a Clinical Opiate Withdrawal Scale [COWS] score ≤5 on the Naloxone Challenge) but has experience in the use of opioids for non-therapeutic purposes (ie, for psychoactive effects) on at least 10 occasions within the last year and at least once in the 12 weeks prior to the screening visit.
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- Subject demonstrates adequate VRH at screening during VRH assessment, defined as a minimum increase in ETCO2 of 10 mmHg and an increase in minute ventilation appropriate per investigator's discretion.
- Ability and willingness to abstain from alcohol-, caffeine-, and xanthine-containing beverages or food (eg, coffee, tea, cola, chocolate, energy drinks) as well as poppy seeds from 48 hours (2 days) prior to each admission to the clinical facility until study discharge (including clinic furloughs).
- Female subjects who are non-pregnant, non-lactating, and either postmenopausal for at least 1 year or surgically sterile for at least 3 months, or, if of childbearing potential, will agree to use adequate contraception from 28 days and/or their last confirmed menstrual period prior to study enrollment (whichever is longer) until 90 days after the follow-up visit. Male subjects, if not surgically sterilized, must agree to use adequate contraception and not donate sperm from first admission to the clinical research center until 90 days after the follow-up visit. Adequate contraception (for both males and females) is defined as using spermicide with a single barrier method: diaphragm, cervical cap, or condom. For female participants and female partners of male participants, being surgically sterilized or using hormonal contraception or an intrauterine device is also acceptable. Also, total abstinence, in accordance with the lifestyle of the subject, is acceptable.
- For female subjects: a negative pregnancy test at screening and Day -1 of each treatment period.
- Postmenopausal females: defined as 12 months with no menses prior to screening and a serum follicle stimulating hormone (FSH) >40 IU/L at screening.
- All prescribed medications, over-the-counter (OTC) medications, dietary supplements or herbal supplements (eg, St. John's Wort extract) must have been stopped at least 14 days prior to the first admission to the clinical research center. An exception is made for acetaminophen, which is allowed up to admission to the clinical research center. An exception is also made for hormonal contraceptives, which may be used throughout the study. Antiemetics may be allowed after the 4-hour VRH assessments while confined in the clinical research unit.
Who cannot join
- Employee of PRA or the Sponsor.
- Women who are pregnant, lactating, or planning to attempt to become pregnant during this study or within 90 days after the follow-up visit.
- Male subjects with female partners who are pregnant, lactating, or planning to attempt to become pregnant during this study or within 90 days after the follow-up visit.
- Has received study medication in another clinical trial within 30 days prior to the first dose of study medication.
- Having any disease that, in the opinion of the investigator, poses an unacceptable risk to the subjects.
- History of drug allergy diagnosed by a physician. Confirmatory circumstances would include treatment with epinephrine or an Emergency Department.
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- Subjects who have smoked on a daily basis within 30 days prior to the first dose of study medication. Occasional nicotine use in the form of cigarettes, cigars, or vape pen is allowable (defined as less than half a pack of cigarettes [10 cigarettes], equivalent vaping [100 puffs], or no more than 2 cigars per week). Nicotine replacement therapies (ie, patches and/or gum) may be used without restriction.
- Routine or chronic use of more than 3 grams of acetaminophen daily.
- Strenuous activity and contact sports within 48 hours (2 days) prior to first admission to the clinical facility and for the duration of the study.
- History of donation of more than 450 mL of blood within 60 days prior to dosing in the clinical research center or planned donation before 30 days has elapsed since intake of study drug.
- Plasma or platelet donation within 7 days of first dose administration and throughout the entire study.
- History of or presence of alcohol dependence. This includes subjects who have never been to a drug rehabilitation program. Alcohol consumption will be prohibited 48 hours prior to admission to the clinical facility and throughout the entire study until discharge.
- Positive screening test for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, or antihuman immunodeficiency virus (HIV)-1 and -2 antibodies.
- History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease, or any other condition, which, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results.
- Has any condition in which an opioid is contraindicated (eg, significant respiratory depression, acute or severe bronchial asthma or hypercarbia, or has or is suspected of having paralytic ileus).
- Have a history of chronic obstructive pulmonary disease or any other lung disease (eg, asthma, bronchitis, obstructive sleep apnea, exercise-induced asthma) that would cause CO2 retention.
- Has participated in (within the last 5 years), is currently participating in, or is seeking treatment for substance-related disorders (excluding nicotine and caffeine).
- A positive result for drugs of abuse (amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, and opioids, including oxycodone) at screening is acceptable as long as the urine drug screen is negative for these drugs at admission to the clinical facility. A positive test for THC is not exclusionary at screening or at admission to the clinical facility. If a subject has a positive urine drug screen (except THC) upon admission to the clinic (V3-V7) the subject will be dismissed from the clinic and will be allowed to return at a later date (+14 days) to participate in the missed treatment period. A subject may only test positive once (except THC) and be allowed to return.
- Has oral sores, mucositis, or inflammation in oral cavity at screening and check-in.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Double Dummy, 6-Period, Placebo-Controlled, Crossover Study to Explore and Compare the Ventilatory Response to Hypercapnia (VRH), of Belbuca, Oxycodone Hydrochloride (HCl) and Placebo in Recreational Opioid Users
The purpose of this study is to explore and compare VRH after administration of Belbuca, Oxycodone HCl and Placebo in recreational opioid users. This is a single-center, double -blind, double-dummy , placebo-controlled randomized crossover study in up to 18 men and women self identifying as recreational users. This study will consist of a screening phase, treatment phase (which includes the Naloxone Challenge test) and follow-up visit.
- Conditions
- Respiratory Depression
- Being tested
- Belbuca 300 µg, Belbuca 600 µg, Belbuca 900 µg, Oxycodone 30 mg, Oxycodone 60 mg
- Keywords
- Chronic Pain, Ventilatory Response to Hypercapnia (VRH)
- Medical subject headings
- Respiratory Insufficiency, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Belbuca 300 µgDrug
Belbuca 300 µg buccal film
Belbuca 600 µgDrug
Belbuca 600 µg buccal film
Belbuca 900 µgDrug
Belbuca 900 µg buccal film
Oxycodone 30 mgDrug
Oxycodone 30 mg capsule
Oxycodone 60 mgDrug
Oxycodone 60 mg capsule
PlaceboDrug
placebo buccal film and oral placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment A: Belbuca 300 µg and oral placebo | Experimental | Subjects treated with Belbuca 300 µg and oral placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio. Receives: Drug: Belbuca 300 µg |
| Treatment B: Belbuca 600 µg and oral placebo | Experimental | Subjects treated with Belbuca 600 µg and oral placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio. Receives: Drug: Belbuca 600 µg |
| Treatment C: Belbuca 900 µg and oral placebo | Experimental | Subjects treated with Belbuca 900 µg and oral placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio. Receives: Drug: Belbuca 900 µg |
| Treatment D: Oxycodone 30 mg and buccal placebo | Active comparator | Subjects treated with Oxycodone 30 mg and buccal placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio. Receives: Drug: Oxycodone 30 mg |
| Treatment E: Oxycodone 60 mg and buccal placebo | Active comparator | Subjects treated with Oxycodone 60 mg and buccal placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio. Receives: Drug: Oxycodone 60 mg |
| Treatment F: Oral Placebo and buccal placebo | Placebo comparator | Subjects treated with oral placebo and buccal placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Drive
Respiratory drive was evaluated by measuring the Ventilatory Response to Hypercapnia (VRH) through assessment of the maximum decrease (Emax) in minute ventilation (mL/min) after administration of Belbuca, Oxycodone hydrochloride, and placebo.
Measured: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3 and 4 hours
Secondary outcomes (3)
Pupil Diameter
Pupil diameter will be assessed by pupillometry predose and at multiple timepoints after completion of Belbuca, oxycodone hydrochloride, and placebo dosing.
Measured: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3 and 4 hours
Change in Ratio of Minute Ventilation
Change in ratio of maximum decrease (Emax) in minute ventilation (mL/min) over maximum (Emax) end-tidal carbon dioxide (CO2, mmHg) after administration of Belbuca, oxycodone hydrochloride, and placebo.
Measured: pre-dose, 0.5, 1, 2, 2.5, 3 and 4 hours
Adverse Event (AE) Reporting of Belbuca, Oxycodone Hydrochloride and Placebo for 6 Periods.
Number of Participants with indicated Adverse Event (AE) in subjects receiving Belbuca, oxycodone hydrochloride, and placebo for 6 periods.
Measured: 44 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start23 Jul 2019
- Primary completion27 Oct 2019
- Study completion27 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiratory DepressionStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioDelivery Sciences International
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Responsible party
- Sponsor
- Investigators
- Lynn Webster, Principal investigator, PRA Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03996694
- Sponsor's protocol ID
- BUP-401
- Status last verified
- Jan 2021
- First submitted
- 21 Jun 2019
- Last updated
- 5 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Webster LR, Cater J, Smith T. Pharmacokinetics of Buprenorphine Buccal Film and Orally-administered Oxycodone in a Respiratory Study: An Analysis of Secondary Outcomes from a Randomized Controlled Trial. Pain Ther. 2022 Sep;11(3):817-825. doi: 10.1007/s40122-022-00380-2. Epub 2022 May 7.
PubMed 35524938Webster LR, Hansen E, Cater J, Smith T. A Phase I Placebo-Controlled Trial Comparing the Effects of Buprenorphine Buccal Film and Oral Oxycodone Hydrochloride Administration on Respiratory Drive. Adv Ther. 2020 Nov;37(11):4685-4696. doi: 10.1007/s12325-020-01481-0. Epub 2020 Sep 25.
PubMed 32978722
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Double Dummy, 6-Period, Placebo-Controlled, Crossover Study to Explore and Compare the Ventilatory Response to Hypercapnia (VRH), of Belbuca, Oxycodone Hydrochloride (HCl) and Placebo in Recreational Opioid Users
- ClinicalTrials.gov ID
- NCT03996694
- Acronym / sponsor ID
- BUP-401
- Conditions
- Respiratory Depression
- Keywords
- Chronic Pain, Ventilatory Response to Hypercapnia (VRH)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- BioDelivery Sciences InternationalIndustry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Study start
- 23 Jul 2019 (actual)
- Primary completion
- 27 Oct 2019 (actual)
- Study completion
- 27 Oct 2019 (actual)
- First posted
- 25 Jun 2019 (actual)
- Results
- Posted 5 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to explore and compare VRH after administration of Belbuca, Oxycodone HCl and Placebo in recreational opioid users. This is a single-center, double -blind, double-dummy , placebo-controlled randomized crossover study in up to 18 men and women self identifying as recreational users. This study will consist of a screening phase, treatment phase (which includes the Naloxone Challenge test) and follow-up visit.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Treatment A: Belbuca 300 µg and oral placebo | Experimental | Drug: Belbuca 300 µgSubjects treated with Belbuca 300 µg and oral placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio. |
| Treatment B: Belbuca 600 µg and oral placebo | Experimental | Drug: Belbuca 600 µgSubjects treated with Belbuca 600 µg and oral placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio. |
| Treatment C: Belbuca 900 µg and oral placebo | Experimental | Drug: Belbuca 900 µgSubjects treated with Belbuca 900 µg and oral placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio. |
| Treatment D: Oxycodone 30 mg and buccal placebo | Active comparator | Drug: Oxycodone 30 mgSubjects treated with Oxycodone 30 mg and buccal placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio. |
| Treatment E: Oxycodone 60 mg and buccal placebo | Active comparator | Drug: Oxycodone 60 mgSubjects treated with Oxycodone 60 mg and buccal placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio. |
| Treatment F: Oral Placebo and buccal placebo | Placebo comparator | Drug: PlaceboSubjects treated with oral placebo and buccal placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Male or female subjects 18 to 55 years of age, inclusive.
- Subjects are in good health as indicated by medical history, PE, vital signs, oxygen saturation, clinical laboratory tests, and 12-lead ECG. A status of good health will be defined by the absence of evidence of any clinically significant, active or chronic disease based on these assessments, in the opinion of the investigator.
- Subjects with a body mass index (BMI) of 18.0 to 33.0 kg/m2, inclusive, and body weight greater than 50 kg, inclusive.
- Subject is able to speak, read, and understand English and voluntarily provide written informed consent to participate in the study.
- Subjects have healthy oral mucosa as determined by examination at screening and admission to the clinical facility.
Key exclusion criteria (19 listed)
- Employee of PRA or the Sponsor.
- Women who are pregnant, lactating, or planning to attempt to become pregnant during this study or within 90 days after the follow-up visit.
- Male subjects with female partners who are pregnant, lactating, or planning to attempt to become pregnant during this study or within 90 days after the follow-up visit.
- Has received study medication in another clinical trial within 30 days prior to the first dose of study medication.
- Having any disease that, in the opinion of the investigator, poses an unacceptable risk to the subjects.
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 |
|---|---|---|
| Belbuca 300 µgBelbuca 300 µg buccal film | Drug | Treatment A: Belbuca 300 µg and oral placebo |
| Belbuca 600 µgBelbuca 600 µg buccal film | Drug | Treatment B: Belbuca 600 µg and oral placebo |
| Belbuca 900 µgBelbuca 900 µg buccal film | Drug | Treatment C: Belbuca 900 µg and oral placebo |
| Oxycodone 30 mgOxycodone 30 mg capsule | Drug | Treatment D: Oxycodone 30 mg and buccal placebo |
| Oxycodone 60 mgOxycodone 60 mg capsule | Drug | Treatment E: Oxycodone 60 mg and buccal placebo |
| Placeboplacebo buccal film and oral placebo | Drug | Treatment F: Oral Placebo and buccal placebo |
Primary outcome
Respiratory Drive
Time frame: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3 and 4 hours
Respiratory drive was evaluated by measuring the Ventilatory Response to Hypercapnia (VRH) through assessment of the maximum decrease (Emax) in minute ventilation (mL/min) after administration of Belbuca, Oxycodone hydrochloride, and placebo.
3 secondary outcomes
Pupil Diameter
Time frame: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3 and 4 hours
Change in Ratio of Minute Ventilation
Time frame: pre-dose, 0.5, 1, 2, 2.5, 3 and 4 hours
Adverse Event (AE) Reporting of Belbuca, Oxycodone Hydrochloride and Placebo for 6 Periods.
Time frame: 44 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35524938Webster LR, Cater J, Smith T. Pharmacokinetics of Buprenorphine Buccal Film and Orally-administered Oxycodone in a Respiratory Study: An Analysis of Secondary Outcomes from a Randomized Controlled Trial. Pain Ther. 2022 Sep;11(3):817-825. doi: 10.1007/s40122-022-00380-2. Epub 2022 May 7.
- Derived from this study: PubMed 32978722Webster LR, Hansen E, Cater J, Smith T. A Phase I Placebo-Controlled Trial Comparing the Effects of Buprenorphine Buccal Film and Oral Oxycodone Hydrochloride Administration on Respiratory Drive. Adv Ther. 2020 Nov;37(11):4685-4696. doi: 10.1007/s12325-020-01481-0. Epub 2020 Sep 25.
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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.
Lynn Webster principal investigator
PRA Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Belbuca 300 µg, Belbuca 600 µg and Belbuca 900 µg in people with Respiratory Depression, run by BioDelivery Sciences International 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 12 inclusion and 19 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: finished, as of the sponsor's last update on 5 Feb 2021. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory Drive (time frame: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3 and 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03996694, which also lists 2 linked publications.
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 5 Feb 2021.