NCT03986762

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Temple University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Clavulanic Acid	\~10 days of Clavulanic Acid

Timeline

• Start date: 2019-03-12
• Primary completion: 2019-12-20
• Completion: 2019-12-20
• First posted: 2019-06-14
• Last updated: 2020-10-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study