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

Study Overview
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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.

Official Title
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A Phase IA Open Label Pharmaco- Magnetic Resonance Spectrography (MRS) Study of Clavulanic Acid Daily Repeated Administration in Remitted Cocaine Use Disorder Subjects

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

Intervention / Treatment
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* Drug: Clavulanic Acid


Participation Criteria
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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 (For full inclusion/exclusion criteria or for more information, please contact the site directly.)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open Label Clav<br> | Drug: Clavulanic Acid<br>*  10 days of Clavulanic Acid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glutamate change after dose stoppage | Change in brain glutamate concentration in 2 brain areas associated with addiction at Day 11 compared with Day 10. | 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. | 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. | 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. | 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. | 1-31 days (during and after study dosing period) |