Clavulanic Acid (CLAV) and Cocaine Interaction Safety Study
NCT ID: NCT02563769
Last Updated: 2023-11-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
10 participants
INTERVENTIONAL
2016-10-24
2018-05-25
Brief Summary
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Detailed Description
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The primary objective will be to determine whether there are clinically significant adverse interactions between CLAV (250 mg/day; 500 mg/day; 750 mg/day) and intravenously administered cocaine in healthy, non-treatment seeking adults with cocaine use disorder.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Clavulanic Acid (CLAV) 250mg; CLAV 500mg then Placebo (PBO)
Clavulanic acid OR Placebo to be given in combination with intravenous cocaine; Day #2: Clavulanic Acid 250 mg (low dose); Day #3: Clavulanic Acid 500 mg; Day #4: Placebo
Clavulanic acid
Clavulanic acid will be administered orally in 250mg capsules
Intravenous cocaine
20/40mg Cocaine will be administered by IV
Placebo
Placebo will be administered orally in capsules identical to CLAV and be filled with crystalline microcellulose
CLAV 250mg; PBO; then CLAV 500mg
Clavulanic acid OR Placebo to be given in combination with intravenous cocaine; Day #2: Clavulanic Acid 250 mg (low dose); Day #3: Placebo; Day #4: Clavulanic Acid 500 mg
Clavulanic acid
Clavulanic acid will be administered orally in 250mg capsules
Intravenous cocaine
20/40mg Cocaine will be administered by IV
Placebo
Placebo will be administered orally in capsules identical to CLAV and be filled with crystalline microcellulose
PBO; CLAV 250mg; then CLAV 500mg
Clavulanic acid OR Placebo to be given in combination with intravenous cocaine; Day #2: Placebo; Day #3: Clavulanic Acid 250 mg (low dose); Day #4: Clavulanic Acid 500 mg
Clavulanic acid
Clavulanic acid will be administered orally in 250mg capsules
Intravenous cocaine
20/40mg Cocaine will be administered by IV
Placebo
Placebo will be administered orally in capsules identical to CLAV and be filled with crystalline microcellulose
Interventions
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Clavulanic acid
Clavulanic acid will be administered orally in 250mg capsules
Intravenous cocaine
20/40mg Cocaine will be administered by IV
Placebo
Placebo will be administered orally in capsules identical to CLAV and be filled with crystalline microcellulose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Be a non-treatment seeking cocaine user.
* If female and of childbearing potential, must have a negative pregnancy test within 48 hours of beginning the study and be willing to use acceptable contraception or be abstinent for 14 days prior to study, through the entire study and 30 days after study participation.
Exclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
University of Pennsylvania
OTHER
Temple University
OTHER
Responsible Party
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Principal Investigators
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Kyle M. Kampman, M.D.
Role: PRINCIPAL_INVESTIGATOR
U54 Principal Investigator - University of Pennsylvania
Mary F. Morrison, M.D., M.S.
Role: PRINCIPAL_INVESTIGATOR
Temple University
M. I Walters, M.D.
Role: PRINCIPAL_INVESTIGATOR
Temple University
Locations
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Temple University Hospital - Episcopal Campus
Philadelphia, Pennsylvania, United States
Countries
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References
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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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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23222
Identifier Type: -
Identifier Source: org_study_id
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