Open Label Pharmaco- Magnetic Resonance Spectrography (MRS) Study of Clavulanic Acid (CLAVMRPilot)
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|ClinicalTrials.gov Identifier: NCT03986762|
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cocaine Dependence, in Remission Cocaine Abuse, in Remission Cocaine-Related Disorders||Drug: Clavulanic Acid||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase IA Open Label Pharmaco- Magnetic Resonance Spectrography (MRS) Study of Clavulanic Acid Daily Repeated Administration in Remitted Cocaine Use Disorder Subjects|
|Actual Study Start Date :||March 12, 2019|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
|Experimental: Open Label Clav||
Drug: Clavulanic Acid
~10 days of Clavulanic Acid
- Glutamate change from baseline [ Time Frame: 10-17 Days ]Change in brain glutamate concentration at Day 10-17 compared with baseline.
- Glutamate/creatine ratio change from baseline [ Time Frame: 10-17 Days ]Change in brain glutamate/creatine ratio at Day 10-17
- Glutamate change after dose stoppage [ Time Frame: Day 10-11 ]Change in brain glutamate concentration in 2 brain areas associated with addiction at Day 11 compared with Day 10.
- Glutamate/creatine ratio change after dose stoppage [ Time Frame: Day 10-11 ]Change in brain glutamate/creatine ratio in 2 brain areas associated with addiction at Day 11 compared with Day 10.
- Change in brain glutamine from baseline [ Time Frame: 10-17 Days ]Change in brain glutamine concentration in 2 brain areas at Day 10-17 compared with baseline.
- Change in brain glutamine/creatine ratio from baseline [ Time Frame: 10-17 Days ]Change in glutamine/creatine ratio in 2 brain areas at Day 10-17 compared with baseline.
- 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. [ Time Frame: 1-31 days (during and after study dosing period) ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986762
|Contact: Eric M Cunningham, BAfirstname.lastname@example.org|
|Contact: Helene Philogene-Khalid, PhD||Helene.Khalid@tuhs.temple.edu|
|United States, Pennsylvania|
|Episcopal Hospital Medical Arts Building||Recruiting|
|Philadelphia, Pennsylvania, United States, 19125|
|Contact: Eric Cunningham, BA 215-707-7915 email@example.com|
|Principal Investigator:||Mary F Morrison, M.D.||Temple University|