drugset / Trial / NCT02563769
Clavulanic Acid (CLAV) and Cocaine Interaction Safety Study
Phase 1
Completed
10 enrolled
Temple University
National Institute on Drug Abuse (NIDA) · collabUniversity of Pennsylvania · collab
RandomizedCrossoverDouble-blindTreatment
Summary
The main purpose of this study is to determine if it is safe to use the study drug, clavulanic acid, in combination with cocaine. In this study, subjects will receive intravenous (i.v.) cocaine and the study drug, clavulanic acid. The safety of clavulanic acid is being studied so future studies can be done to find out if this drug is helpful in treating cocaine dependence. Currently, there is no available medication treatment for cocaine dependence.
Timeline
- Start
- 2016-10-24
- Primary completion
- 2018-05-25
- Completion
- 2018-05-25
Publications
- Background Uys JD, LaLumiere RT. Glutamate: the new frontier in pharmacotherapy for cocaine addiction. CNS Neurol Disord Drug Targets. 2008 Nov;7(5):482-91. doi: 10.2174/187152708786927868.
- Background Rasmussen BA, Baron DA, Kim JK, Unterwald EM, Rawls SM. beta-Lactam antibiotic produces a sustained reduction in extracellular glutamate in the nucleus accumbens of rats. Amino Acids. 2011 Feb;40(2):761-4. doi: 10.1007/s00726-010-0589-0. Epub 2010 Apr 13.
- Background Ward SJ, Rasmussen BA, Corley G, Henry C, Kim JK, Walker EA, Rawls SM. Beta-lactam antibiotic decreases acquisition of and motivation to respond for cocaine, but not sweet food, in C57Bl/6 mice. Behav Pharmacol. 2011 Aug;22(4):370-3. doi: 10.1097/FBP.0b013e3283473c10.
- Background Kovalevich J, Corley G, Yen W, Rawls SM, Langford D. Cocaine-induced loss of white matter proteins in the adult mouse nucleus accumbens is attenuated by administration of a beta-lactam antibiotic during cocaine withdrawal. Am J Pathol. 2012 Dec;181(6):1921-7. doi: 10.1016/j.ajpath.2012.08.013. Epub 2012 Sep 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cocaine | Small molecule | 20 mg | Intravenous |
| Subject | Cocaine | Small molecule | 40 mg | Intravenous |
| Subject | clavulanic acid | Small molecule | 250 mg | Oral |
| Subject | clavulanic acid | Small molecule | 500 mg | Oral |
| Subject | clavulanic acid | Small molecule | 750 mg | Oral |