drugset / Trial / NCT03996694
Single Dose Crossover Study to Compare the Respiratory Drive After Administration of Belbuca, Oxycodone and Placebo.
RandomizedCrossoverDouble-blindBasic science
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. This study will consist of a screening phase, treatment phase (which includes the Naloxone Challenge test) and follow-up visit.
Timeline
- Start
- 2019-07-23
- Primary completion
- 2019-10-27
- Completion
- 2019-10-27
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.
- Webster 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Buprenorphine | Other / unclassified | 300 ug | Other |
| Subject | Buprenorphine | Other / unclassified | 600 ug | Other |
| Subject | Buprenorphine | Other / unclassified | 900 ug | Other |
| Comparator | Oxycodone | Other / unclassified | 30 mg | Oral |
| Comparator | Oxycodone | Other / unclassified | 60 mg | Oral |