Pharmaco-Magnetic Resonance Spectroscopy (MRS) Study of Clavulanic Acid

Status Completed

Clinical Trial Summary

A dose-escalation study to determine the optimum dose of Clavulanic Acid (CLAV) for effects on craving and efficacy.

Clinical Trial Description

This is a randomized, double-blind, placebo-controlled, parallel group inpatient study of clavulanic acid for 10 days in adults (18-65) seeking treatment for cocaine use disorder. For those subjects who can tolerate 500 mg/day for 3 days (or matched placebo), there will be a forced dose escalation to 750 mg/day for 3 days. Subjects who can tolerate 750 mg/day for three days will have a forced dose escalation to 1000 mg/day for 4 days until the study ends. Thus, there are 3 Periods for each participant: Period 1: 500 mg CLAV per day for days 1-3; Period 2: 750 mg per day for days 4-6; Period 3: 1000 mg/day for days 7-10. Subjective, cognitive, and adverse effect assessments, blood pressure and pulse will be performed daily. Structural MRI, resting state MRI (rs-fMRI), functional MRI (fMRI) and Magnetic Resonance Spectroscopy (MRS) scans will be done at baseline and on Days 3, 6 and 10 of the study. At the time of each scan, safety of the subject to complete the scan will be re-assessed. fMRI was not done at baseline. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04411914
Study type	Interventional
Source	Temple University
Contact
Status	Completed
Phase	Phase 1
Start date	September 1, 2020
Completion date	March 31, 2022

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