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Alcohol Dependency Study: Combining Medication Treatment for Alcoholism

Primary Purpose

Alcoholism

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ondansetron + cognitive behavioral therapy
topiramate + cognitive behavioral therapy
Placebo + cognitive behavioral therapy
ondansetron + topiramate + cognitive behavioral therapy
Sponsored by
Bankole Johnson
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism focused on measuring alcoholism, alcohol addiction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: Please contact site for additional information

Sites / Locations

  • University of Virginia Center for Addiction Research and EducationRecruiting
  • University of Virginia Center for Addiction Research and EducationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Experimental

Arm Label

Ondansetron

Topiramate

Placebo

Ondansetron + Topiramate

Arm Description

Ondansetron + cognitive behavioral therapy

Topiramate + cognitive behavioral therapy

Placebo + cognitive behavioral therapy

Ondansetron + Topiramate + cognitive behavioral therapy

Outcomes

Primary Outcome Measures

Self-report measures of alcohol-related problems and consumption, Objective measures of alcohol consumption
Drinks per drinking day, Drinks per day, Percent Days Abstinent, BAC, CDT, GGT

Secondary Outcome Measures

Medication compliance, alcohol craving, social functioning, quality of life, alcohol withdrawal, attendance at psychosocial services, pre-morbid risk factors
Pill Count, Q-LES-Q, SFQ, AASE, ADBS, OCDS, CIWA-Ar, CGI, TCI, MAC, AOQ, FHAM

Full Information

First Posted
September 11, 2000
Last Updated
March 14, 2013
Sponsor
Bankole Johnson
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00006205
Brief Title
Alcohol Dependency Study: Combining Medication Treatment for Alcoholism
Official Title
Combining Medications Treatment for Alcoholism
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2005 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bankole Johnson
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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 checks, and cognitive 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism
Keywords
alcoholism, alcohol addiction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ondansetron
Arm Type
Experimental
Arm Description
Ondansetron + cognitive behavioral therapy
Arm Title
Topiramate
Arm Type
Experimental
Arm Description
Topiramate + cognitive behavioral therapy
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo + cognitive behavioral therapy
Arm Title
Ondansetron + Topiramate
Arm Type
Experimental
Arm Description
Ondansetron + Topiramate + cognitive behavioral therapy
Intervention Type
Drug
Intervention Name(s)
ondansetron + cognitive behavioral therapy
Other Intervention Name(s)
Zofran
Intervention Description
ondansetron (4 mcg/kg b.i.d)
Intervention Type
Drug
Intervention Name(s)
topiramate + cognitive behavioral therapy
Other Intervention Name(s)
Topamax
Intervention Description
topiramate (up to 300 mg/day)
Intervention Type
Drug
Intervention Name(s)
Placebo + cognitive behavioral therapy
Other Intervention Name(s)
sugar pill
Intervention Description
placebo
Intervention Type
Drug
Intervention Name(s)
ondansetron + topiramate + cognitive behavioral therapy
Other Intervention Name(s)
zofran, topamax
Intervention Description
ondansetron (4 mcg/kg b.i.d) + topiramate (up to 300 mg/day)
Primary Outcome Measure Information:
Title
Self-report measures of alcohol-related problems and consumption, Objective measures of alcohol consumption
Description
Drinks per drinking day, Drinks per day, Percent Days Abstinent, BAC, CDT, GGT
Time Frame
Throughout the study
Secondary Outcome Measure Information:
Title
Medication compliance, alcohol craving, social functioning, quality of life, alcohol withdrawal, attendance at psychosocial services, pre-morbid risk factors
Description
Pill Count, Q-LES-Q, SFQ, AASE, ADBS, OCDS, CIWA-Ar, CGI, TCI, MAC, AOQ, FHAM
Time Frame
Throughout the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: Please contact site for additional information
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mindy Borszich
Phone
1-888-882-2345
Email
mcb3x@virginia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Eva Jenkins-Mendoza
Phone
(434) 243-0562
Email
emj9c@virginia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bankole Johnson, DSc, MD, PhD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia Center for Addiction Research and Education
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mindy Borszich
Phone
888-882-2345
Email
mcb3x@virginia.edu
First Name & Middle Initial & Last Name & Degree
Eva Jenkins-Mendoza
Phone
(434)243-0562
Email
emj9c@virginia.edu
First Name & Middle Initial & Last Name & Degree
Bankole Johnson, DSc, MD, PhD
First Name & Middle Initial & Last Name & Degree
Nassima Ait-Daoud Tiouririne, MD
Facility Name
University of Virginia Center for Addiction Research and Education
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mindy Borszich
Phone
888-882-2345
Email
mcb3x@virginia.edu
First Name & Middle Initial & Last Name & Degree
Eva Jenkins-Mendoza
Phone
(434)243-0562
Email
emj9c@virginia.edu
First Name & Middle Initial & Last Name & Degree
Bankole Johnson, DSc, MD, PhD
First Name & Middle Initial & Last Name & Degree
Nassima Ait-Daoud Tiouririne, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
15330732
Citation
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. doi: 10.1517/14656566.5.9.1943.
Results Reference
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Alcohol Dependency Study: Combining Medication Treatment for Alcoholism

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