Combined Pharmacotherapies for Alcoholism

Status Completed

Clinical Trial Summary

This study would like to test whether the combination of ondansetron and naltrexone will be superior to either medication alone or placebo in the treatment of alcohol dependence.

Clinical Trial Description

We propose to conduct a 13 week randomized, controlled clinical trial to evaluate the safety and efficacy of ondansetron and naltrexone alone and in combination.Eligible subjects will be randomized to placebo, ondansetron, naltrexone, or ondansetron + naltrexone treatments. All subjects will receive a weekly CBT (Cognitive Behavioral Therapy)sessions. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Alcoholism

Clinical Trial Details

NCT number	NCT00768508
Study type	Interventional
Source	University of Virginia
Contact
Status	Completed
Phase	Phase 3
Start date	September 2008
Completion date	December 2012

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05054738` - CRP and S&A for Inpatient Veterans	N/A
Completed	`NCT02233738` - Group Motivational Interviewing (GMI) For Homeless Veterans In VA Services	N/A
Completed	`NCT05877807` - Effect of Baclofen to Prevent Post-Traumatic Stress Disorder
Completed	`NCT00000437` - Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)	Phase 4
Completed	`NCT00536146` - The Stress-Hormone System in Alcohol-Dependent Subjects	N/A
Terminated	`NCT00890149` - Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults	Phase 2
Completed	`NCT02939352` - The Effects of Theta Burst Stimulation on the Brain Response to Drug and Alcohol Cues	Early Phase 1
Completed	`NCT02179749` - Mifepristone Treatment of Alcohol Use Disorder	Phase 2
Terminated	`NCT01408641` - Topiramate for Alcohol Use in Posttraumatic Stress Disorder	N/A
Completed	`NCT01553136` - Varenicline Treatment of Alcohol Dependence in Smokers	Phase 2
Completed	`NCT01389297` - Overcoming Addictions: A Randomized Clinical Trial of a Web Application Based on SMART Recovery	N/A
Completed	`NCT01760785` - Valproate for Mood Swings and Alcohol Use Following Head Injury	N/A
Completed	`NCT01113164` - Matching Genotypes and Serotonergic Medications for Alcoholism	Phase 1
Completed	`NCT00127231` - Brief Therapy Intervention for Heavy/Hazardous Drinking in HIV-Positive Women	N/A
Terminated	`NCT02842528` - Cognitive Vulnerability Factors in Alcohol-dependence	N/A
Completed	`NCT00367575` - An Internet-based Intervention for Problem Drinking	N/A
Completed	`NCT00167687` - Prazosin Alcohol Dependence IVR Study	Phase 4
Completed	`NCT00223639` - New Medications to Treat Alcohol Dependence	Phase 2
Completed	`NCT00583440` - 12-step Facilitation for the Dually Diagnosed	Phase 1/Phase 2
Recruiting	`NCT00447785` - Endocrine Regulation of Energy and Fluid Supplies in Alcoholic Patients	N/A