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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
\~10 days of Clavulanic Acid
Episcopal Hospital Medical Arts Building
Philadelphia, Pennsylvania, United States
Glutamate change from baseline
Change in brain glutamate concentration at Day 10-17 compared with baseline.
Time frame: 10-17 Days
Glutamate/creatine ratio change from baseline
Change in brain glutamate/creatine ratio at Day 10-17
Time frame: 10-17 Days
Glutamate change after dose stoppage
Change in brain glutamate concentration in 2 brain areas associated with addiction at Day 11 compared with Day 10.
Time frame: Day 10-11
Glutamate/creatine ratio change after dose stoppage
Change in brain glutamate/creatine ratio in 2 brain areas associated with addiction at Day 11 compared with Day 10.
Time frame: Day 10-11
Change in brain glutamine from baseline
Change in brain glutamine concentration in 2 brain areas at Day 10-17 compared with baseline.
Time frame: 10-17 Days
Change in brain glutamine/creatine ratio from baseline
Change in glutamine/creatine ratio in 2 brain areas at Day 10-17 compared with baseline.
Time frame: 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.
Adverse events (AES) will be defined as any clinically significant changes in vital signs, indications of suicidal ideation or behavior on the Columbia Suicide Severity Rating Scale (C-SSRS), clinically significant change in Electrocardiogram (EKG) parameters and clinically significant changes in laboratory bloodwork (Complete blood count, comprehensive metabolic panel, urinalysis), or any self reported side effects compared with baseline. AEs will be collected throughout the study and reviewed by a physician. An evaluation of AE severity (mild, moderate, severe) will be evaluated by a physician based on participant self-report. AEs per subject will be listed by organ system, and the number of AEs within the subject population will be totaled.
Time frame: 1-31 days (during and after study dosing period)
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