The Effects of Topiramate on Alcohol Use in Alcohol Dependent Subjects

This study has been completed.

Study NCT00329407 Information provided by Boston University

First Received on May 22, 2006. Last Updated on August 30, 2010 History of Changes

Results First Received: July 7, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Alcoholism
Intervention:	Drug: Topiramate (Topamax)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Topiramate Treatment	In this open label non-placebo controlled trial all subjects received topiramate, the active medication.

Participant Flow: Overall Study

	Topiramate Treatment
STARTED	10
COMPLETED	9
NOT COMPLETED	1
Withdrawal by Subject	1

Baseline Characteristics

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Reporting Groups

	Description
Topiramate Treatment	In this open label non-placebo controlled trial all subjects received topiramate, the active medication.

Baseline Measures

	Topiramate Treatment
Number of Participants [units: participants]	10
Age [units: participants]
<=18 years	0
Between 18 and 65 years	10
>=65 years	0
Age [units: years] Mean ± Standard Deviation	50.7 ± 8.9
Gender [units: participants]
Female	3
Male	7
Region of Enrollment [units: participants]
United States	10

Outcome Measures

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1. Primary:

The Primary Outcome Measure Will be Subjects Ethanol Consumption Over the Course of the Drug Treatment Period as Assessed by the Timeline Followback Method [ Time Frame: 70 days ]

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2. Secondary:

Phonetic Portion of the Controlled Word Association Test (COWAT) [ Time Frame: Baseline compared to Week 10 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Limitation of this trial include the small number of subjects included and lack of blinding, and inculsion of a placebo control group. An other limitation was the testing the active medication topiramate at om=nly one dose level (i.e. 400 mg daily).

Results Point of Contact:

Name/Title: Ofra sarid-Segal, MD
Organization: Boston University
phone: 617-414-1990
e-mail: ofra.segal@bmc.org

No publications provided

Responsible Party:	Ofra Sarid-Segal, MD, Boston University
ClinicalTrials.gov Identifier:	NCT00329407 History of Changes
Other Study ID Numbers:	H-22296
Study First Received:	May 22, 2006
Results First Received:	July 7, 2010
Last Updated:	August 30, 2010
Health Authority:	United States: Institutional Review Board