drugset / Trial / NCT00734461
Study to Evaluate the Subjective Effects of PTI-801 in Non-Physically Dependent Subjects With a History of Drug Abuse
RandomizedCrossoverTriple-blindTreatment
Summary
This is a single-center, randomized, 7-way crossover, double-blind, active and placebo-controlled study to evaluate the subjective effects of oxycodone combined with ultra-low dose naltrexone in comparison to oxycodone alone in non-physically dependent subjects with a history of opioid abuse. Approximately 14 subjects will be randomized to one of fourteen sequences selected from a balanced 7x7 Latin square design and its mirror image.
Timeline
- Start
- 2007-08
- Primary completion
- 2009-03
- Completion
- 2009-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Naltrexone | Small molecule | 0.0001 mg | — |
| Subject | Naltrexone | Small molecule | 0.001 mg | — |
| Subject | Oxycodone | Other / unclassified | 20 mg | — |
| Subject | Oxycodone | Other / unclassified | 40 mg | — |