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Open Label Pharmaco- Magnetic Resonance Spectrography (MRS) Study of Clavulanic Acid

NCT ID: NCT03986762

Last Updated: 2020-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-12

Study Completion Date

2019-12-20

Brief Summary

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The main purpose of this study is to determine how the study drug, clavulanic acid, affects glutamate in the brain using Magnetic Resonance (MR/MRI) scans. In this study, subjects will receive the study drug, clavulanic acid and undergo 4 MRI scans. This is being studied to determine the correct dosing of clavulanic acid, and to gather data 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.

Detailed Description

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Conditions

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Cocaine Dependence, in Remission Cocaine Abuse, in Remission Cocaine-Related Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open Label Clav

Group Type EXPERIMENTAL

Clavulanic Acid

Intervention Type DRUG

\~10 days of Clavulanic Acid

Interventions

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Clavulanic Acid

\~10 days of Clavulanic Acid

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Meet DSM-5 criteria for cocaine use disorder, moderate to severe in early remission.
* Be male or female adult volunteers ages 18-65 inclusive.
* 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

* Be unable to complete an MRI scan
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Temple University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mary F Morrison, M.D.

Role: PRINCIPAL_INVESTIGATOR

Temple University

Locations

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Episcopal Hospital Medical Arts Building

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

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.

Reference Type BACKGROUND
PMID: 19128205 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20383795 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21543969 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23031254 (View on PubMed)

Ramadan S, Lin A, Stanwell P. Glutamate and glutamine: a review of in vivo MRS in the human brain. NMR Biomed. 2013 Dec;26(12):1630-46. doi: 10.1002/nbm.3045. Epub 2013 Oct 4.

Reference Type BACKGROUND
PMID: 24123328 (View on PubMed)

Other Identifiers

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25506

Identifier Type: -

Identifier Source: org_study_id