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

October 22, 2020 updated by: Temple University

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19125
        • Episcopal Hospital Medical Arts Building

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Open Label Clav
Drug: Clavulanic Acid
~10 days of Clavulanic Acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glutamate change from baseline
Time Frame: 10-17 Days
Change in brain glutamate concentration at Day 10-17 compared with baseline.
10-17 Days
Glutamate/creatine ratio change from baseline
Time Frame: 10-17 Days
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
Time Frame: Day 10-11
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
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.
Day 10-11
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.
10-17 Days
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.
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.
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.
1-31 days (during and after study dosing period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Temple University

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Mary F Morrison, M.D., Temple University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 12, 2019

Primary Completion (ACTUAL)

December 20, 2019

Study Completion (ACTUAL)

December 20, 2019

Study Registration Dates

First Submitted

February 15, 2019

First Submitted That Met QC Criteria

June 11, 2019

First Posted (ACTUAL)

June 14, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 26, 2020

Last Update Submitted That Met QC Criteria

October 22, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25506

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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