NCT03986762

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2019

Completed
25 days until next milestone

Study Start

First participant enrolled

March 12, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 14, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
Last Updated

October 26, 2020

Status Verified

October 1, 2020

Enrollment Period

9 months

First QC Date

February 15, 2019

Last Update Submit

October 22, 2020

Conditions

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

Outcome Measures

Primary Outcomes (2)

  • Glutamate change from baseline

    Change in brain glutamate concentration at Day 10-17 compared with baseline.

    10-17 Days

  • Glutamate/creatine ratio change from baseline

    Change in brain glutamate/creatine ratio at Day 10-17

    10-17 Days

Secondary Outcomes (5)

  • Glutamate change after dose stoppage

    Day 10-11

  • Glutamate/creatine ratio change after dose stoppage

    Day 10-11

  • Change in brain glutamine from baseline

    10-17 Days

  • Change in brain glutamine/creatine ratio from baseline

    10-17 Days

  • Number of participants with treatment-related adverse events (AEs) as assessed by comprehensive metabolic panel, complete blood count, ekg, urinalysis, C-SSRS, and any self-reported change in health.

    1-31 days (during and after study dosing period)

Study Arms (1)

Open Label Clav

EXPERIMENTAL
Drug: Clavulanic Acid

Interventions

Clavulanic AcidDRUG

\~10 days of Clavulanic Acid

Open Label Clav

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Be unable to complete an MRI scan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Episcopal Hospital Medical Arts Building

Philadelphia, Pennsylvania, 19125, United States

Location

Related Publications (5)

  • 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.

    PMID: 19128205BACKGROUND

  • 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.

    PMID: 20383795BACKGROUND

  • 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.

    PMID: 21543969BACKGROUND

  • 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.

    PMID: 23031254BACKGROUND

  • 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.

    PMID: 24123328BACKGROUND

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Clavulanic Acid

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Clavulanic Acidsbeta-LactamsLactamsAmidesOrganic ChemicalsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Mary F Morrison, M.D.

    Temple University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2019

First Posted

June 14, 2019

Study Start

March 12, 2019

Primary Completion

December 20, 2019

Study Completion

December 20, 2019

Last Updated

October 26, 2020

Record last verified: 2020-10

Locations

US(1)