drugset / Trial / NCT02611752
A Multiple Dose Opioid Challenge Study
RandomizedParallel-groupDouble-blindTreatment
Summary
Multi-site, randomized, double-blind, repeat-dose Phase 2 study to evaluate the degree and duration of action of multiple doses of CAM2038 in blocking the effects of hydromorphone in patients with moderate or severe opioid use disorder.
Timeline
- Start
- 2015-10
- Primary completion
- 2016-04
- Completion
- 2016-04
Publications
- Bjornsson M, Acharya C, Strandgarden K, Tiberg F. Population Pharmacokinetic Analysis Supports Initiation Treatment and Bridging from Sublingual Buprenorphine to Subcutaneous Administration of a Buprenorphine Depot (CAM2038) in the Treatment of Opioid Use Disorder. Clin Pharmacokinet. 2023 Oct;62(10):1427-1443. doi: 10.1007/s40262-023-01288-6. Epub 2023 Aug 16.
- Walsh SL, Comer SD, Lofwall MR, Vince B, Levy-Cooperman N, Kelsh D, Coe MA, Jones JD, Nuzzo PA, Tiberg F, Sheldon B, Kim S. Effect of Buprenorphine Weekly Depot (CAM2038) and Hydromorphone Blockade in Individuals With Opioid Use Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Sep 1;74(9):894-902. doi: 10.1001/jamapsychiatry.2017.1874.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Buprenorphine | Other / unclassified | 24 mg | Subcutaneous |
| Subject | Buprenorphine | Other / unclassified | 32 mg | Subcutaneous |