Alcohol Dependency Study: Combining Medication Treatment for Alcoholism - Full Text View

Sponsor:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier:	NCT00006205

Purpose

The purpose of this study is to learn whether ondansetron and topiramate either alone or in combination is safe and effective in the treatment of alcohol dependence. This 13 week out-patient clinical trial is randomized, double-blind, and placebo-controlled. There are post-study follow up visits 1, 2 and 3 months after the end of the study. Participants will receive ondansetron and topiramate either alone or in combination or a placebo coupled with psychotherapy.

Condition	Intervention	Phase
Alcoholism	Drug: ondansetron Drug: topiramate Behavioral: cognitive behavioral Drug: ondansetron + topiramate	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Factorial Assignment, Efficacy Study
Official Title:	Combining Medications Treatment for Alcoholism

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism

Drug Information available for: Topiramate Ondansetron hydrochloride Ondansetron

U.S. FDA Resources

Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Primary Outcome Measures:

Reduction of alcohol consumption [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Abstinence from alcohol consumption [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]

Estimated Enrollment:	320
Study Start Date:	March 2005
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental ondansetron + behavioral therapy	Drug: ondansetron 13 week outpatient trial
2: Experimental topiramate + behavioral therapy	Drug: topiramate 13 week outpatient trial
3: Placebo Comparator placebo + behavioral therapy	Behavioral: cognitive behavioral 13 week outpatient trial
4: Experimental ondansetron + topiramate + behavioral therapy	Drug: ondansetron + topiramate 13 week outpatient trial

Detailed Description:

This study is a 13 week clinical trial. During the 13 weeks participants receive placebo, ondansetron and topiramate alone or in combination. During the 13 weeks participants come to an outpatient clinic to receive the study medication, physical examination, and group behavioral therapy. The duration of the weekly visit is 3 hours. There is a 1, 2, and 3 month post-study follow up visit. Screening for this study is initially done over the telephone and takes 15-20 minutes. If there is nothing found to make someone ineligible to participate, they come to the out-patient clinic for a more thorough in-clinic screening.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Current diagnosis of alcohol dependence and drinking greater than or equal to 14 alcohol drinks/week for women and greater than or equal to 21 alcohol drinks/week for men in the last 30 days.
Provide a written, informed consent.
Good physical health and must weigh within at least 40 kg and no more than 140 kg.
Literate in English and able to read, understand, follow instructions, and complete questionnaires accurately.
Willingness to participate in behavioral treatments for alcoholism.
Provide evidence of stable residence in the last month prior to enrollment in the study and have no plans to move during the next three months.

Exclusion Criteria:

Current existing psychiatric disorder other than alcohol or nicotine dependence.
Elevated liver enzymes greater than four times the upper limit of the normal range or elevated direct bilirubin.
Serious medical co-morbidity requiring medical intervention or close supervision or any condition which can interfere with the receipt of ondansetron.
Severe or life-threatening adverse reactions to medications either in the past or during this clinical trial.
Females who are pregnant, nursing, or not using an acceptable form of contraception at any time during the study.
Received inpatient or outpatient treatment for alcohol dependence within the last 30 days.
Members of the same household.
Treated with medications having a potential effect on alcohol consumption or mood.
Urine must be free of opiates, cocaine, amphetamines, barbiturates, benzodiazepines, and other prescription and non-prescription drugs.
Severe alcohol withdrawal symptoms which require inpatient treatment.
Mandatory participation in an alcohol treatment program.
Pyrexia of unknown origin.
Past or current history or seizures.
Past or current history of recurrent kidney stones.
History of glaucoma.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006205

Contacts

Contact: Mindy Borszich, BA	(434) 243-0549	uvacare@virginia.edu
Contact: Eva Jenkins-Mendoza, BS	(434) 243-0562	uvacare@virginia.edu

Locations

United States, Virginia
University of Virginia Center for Addiction Research and Education	Recruiting
Charlottesville, Virginia, United States, 22911
Contact: Mindy Borszich, BA 434-243-0549 uvacare@virginia.edu
Contact: Eva Jenkins-Mendoza, BS (434)243-0562 uvacare@virginia.edu
Principal Investigator: Bankole Johnson, M.D.
Sub-Investigator: Nassima Ait-Daoud, M.D.
UVA CARE Richmond	Recruiting
Richmond, Virginia, United States, 23294
Principal Investigator: Johnson Bankole, MD
Sub-Investigator: Nassima Ait-Daoud,, MD

Sponsors and Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Principal Investigator:

Bankole Johnson, M.D.

University of Virginia Center for Addiction Research and Education

More Information

Publications:

Johnson BA. An overview of the development of medications including novel anticonvulsants for the treatment of alcohol dependence. Expert Opin Pharmacother. 2004 Sep;5(9):1943-55. Review.

Responsible Party:	University of Virginia Center for Addiction Research and Education ( Bankole Johnson, PhD )
Study ID Numbers:	NIAAAJOH1052207A1, NIH 5R01AA013964-04
Study First Received:	September 11, 2000
Last Updated:	November 20, 2009
ClinicalTrials.gov Identifier:	NCT00006205 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

alcoholism

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Antiemetics
Disorders of Environmental Origin
Neuroprotective Agents
Serotonin Antagonists
Mental Disorders
Therapeutic Uses
Substance-Related Disorders
Topiramate
Antipruritics
Alcohol-Related Disorders
Ondansetron

Dermatologic Agents
Tranquilizing Agents
Gastrointestinal Agents
Central Nervous System Depressants
Antipsychotic Agents
Protective Agents
Pharmacologic Actions
Anti-Obesity Agents
Serotonin Agents
Autonomic Agents
Alcoholism
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on February 08, 2010