Single Dose Crossover Study to Compare the Respiratory Drive After Administration of Belbuca, Oxycodone and Placebo.
CompletedPhase 1NCT03996694
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- 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
- Conditions
- Respiratory Depression
- Interventions
- Drug: Belbuca 300 µg
- Drug: Belbuca 600 µg
- Drug: Belbuca 900 µg
- Drug: Oxycodone 30 mg
- Drug: Oxycodone 60 mg
- Drug: Placebo
- Sponsor
- BioDelivery Sciences International
- Collaborators
- PRA Health Sciences
- Start date
- 2019-07-23
- Primary completion
- 2019-10-27
- Sex
- All
- Age range
- from 18 Years to 55 Years
- Healthy volunteers
- true
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Male or female subjects 18 to 55 years of age, inclusive. 2. 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. 3. Subjects with a body mass index (BMI) of 18.0 to 33.0 kg/m2, inclusive, and body weight greater than 50 kg, inclusive. 4. Subject is able to speak, read, and understand English and voluntarily provide written informed consent to participate in the study. 5. Subjects have healthy oral mucosa as determined by examination at screening and admission to the clinical facility. 6. 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. 7. 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. 8. 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). 9. 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 participan…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03996694