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2014 Garbutt : Neuer klinischer Test angelaufen

Dienstag 20. Mai 2014, 00:04

@all,

eine gute Nachricht :
In den USA ist ein neuer klinischer Test angelaufen :

Efficacy and Safety of High Dose Baclofen for Alcohol Dependence

Verified by: University of North Carolina, Chapel Hill, January 2014
First Received: October 28, 2013 | Last Updated: January 15, 2014
Phase: Phase 2 | Start Date: November 2013
Overall Status: Recruiting | Estimated Enrollment: 120
Brief Summary

Official Title: “Efficacy and Safety of High Dose Baclofen for Alcohol Dependence”

The proposed study will carefully test the hypothesis that a robust dose of baclofen (90 mg/day) has efficacy and is safe in individuals with alcohol dependence. Furthermore, the proposal will test whether an indicator of physical dependence, i.e. drinks/drinking day, predicts response to baclofen. Additionally, the proposal will examine the anti-anxiety effects of baclofen within an alcohol dependent population and ascertain whether baseline levels of anxiety predict response to baclofen.

Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Study Primary Completion Date: October 2017

Clinical Trial Investigator Information

Lead Sponsor
University of North Carolina, Chapel Hill
Provider of Information About this Clinical Study
Principal Investigator: James Garbutt, MD, Professor of Psychiatry, UNC-Chapel Hill – University of North Carolina, Chapel Hill
Overall Official(s)
James C Garbutt, MD, Principal Investigator, University of North Carolina

LG, Werner
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