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Completed

NCT Number: NCT03986762

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

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.

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Key information

Conditions

Cocaine Dependence, in Remission Chemically-Induced Disorders Cocaine Abuse, in Remission Cocaine-Related Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Episcopal Hospital Medical Arts Building

Philadelphia, Pennsylvania, 19125, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Clavulanic Acid

Drug

~10 days of Clavulanic Acid

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Temple University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Acronym: CLAVMRPilot

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 14, 2019
Registry last updated
Oct 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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