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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
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Temple University

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.

Condition or disease Intervention/treatment Phase
Cocaine Dependence, in Remission Cocaine Abuse, in Remission Cocaine-Related Disorders Drug: Clavulanic Acid Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: Open Label Clav Drug: Clavulanic Acid
~10 days of Clavulanic Acid




Primary Outcome Measures :
  1. Glutamate change from baseline [ Time Frame: 10-17 Days ]
    Change in brain glutamate concentration at Day 10-17 compared with baseline.

  2. Glutamate/creatine ratio change from baseline [ Time Frame: 10-17 Days ]
    Change in brain glutamate/creatine ratio at Day 10-17


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.




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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.)


Information from the National Library of Medicine

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


Contacts
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Contact: Eric M Cunningham, BA 215-707-7915 eric.cunningham@tuhs.temple.edu
Contact: Helene Philogene-Khalid, PhD Helene.Khalid@tuhs.temple.edu

Locations
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United States, Pennsylvania
Episcopal Hospital Medical Arts Building Recruiting
Philadelphia, Pennsylvania, United States, 19125
Contact: Eric Cunningham, BA    215-707-7915    eric.cunningham@tuhs.temple.edu   
Sponsors and Collaborators
Temple University
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Mary F Morrison, M.D. Temple University

Publications:
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Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT03986762     History of Changes
Other Study ID Numbers: 25506
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Clavulanic Acids
Clavulanic Acid
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
beta-Lactamase Inhibitors