Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 100 of 593 for:    binge eating disorder

Topiramate for the Treatment of Alcohol Dependent Binge-Eating Disordered Individuals

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00300742
Recruitment Status : Completed
First Posted : March 9, 2006
Results First Posted : May 11, 2017
Last Update Posted : July 12, 2017
Sponsor:
Information provided by (Responsible Party):
Nassima Ait-Daoud Tiouririne, University of Virginia

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Alcohol Dependence
Binge Eating
Intervention Drug: Topiramate
Enrollment 5
Recruitment Details Participants were recruited in Charlottesville and Richmond between September 2006 to February 2007.
Pre-assignment Details  
Arm/Group Title Topiramate/BBCET
Hide Arm/Group Description Escalating dose of up to 300 mg/day of Topiramate
Period Title: Overall Study
Started 5
Completed 3
Not Completed 2
Arm/Group Title Topiramate/BBCET
Hide Arm/Group Description Escalating dose of up to 300 mg/day of Topiramate
Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
<=18 years
0
   0.0%
Between 18 and 65 years
5
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants
45  (10.46422)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
5
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants
5
1.Primary Outcome
Title Compliance With Study Requirements: Attendance at Treatment Sessions
Hide Description [Not Specified]
Time Frame up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Topiramate/BBCET
Hide Arm/Group Description:
Patients receiving an escalating dose of up to 300 mg/day of Topiramate, plus BBCET (Brief Behavioral Compliance Enhancement Treatment)
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: participants
Number of subjects completed through Visit 4 5
Number of subjects completed through Visit 12 3
2.Primary Outcome
Title Mean Drinks Per Day at Baseline vs. Visit 12
Hide Description Mean drinks per day at baseline vs. Visit 12 measured by self report on timeline follow-back (TLFB) calendars in conjunction with the subject's daily diary
Time Frame up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol
Arm/Group Title Topiramate/BBCET
Hide Arm/Group Description:
Escalating dose of up to 300 mg/day of Topiramate, plus BBCET (Brief Behavioral Compliance Enhancement Treatment)at 12 weekly visits following the initial baseline and randomization visits
Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: Drinks/day
Mean drinks per day at baseline 10.95  (13.85)
Mean drinks per day at Visit 12 0.68  (1.13)
3.Primary Outcome
Title Mean Percent Days Abstinent Per Week at Baseline vs. Visit 12
Hide Description Mean percent days abstinent per week at baseline vs. Visit 12 measured by self report on timeline follow-back (TLFB) calendars in conjunction with the subject's daily diary
Time Frame up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol
Arm/Group Title Topiramate/BBCET
Hide Arm/Group Description:
Escalating dose of up to 300 mg/day of Topiramate, plus BBCET (Brief Behavioral Compliance Enhancement Treatment)at 12 weekly visits following the initial baseline and randomization visits
Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: Mean percent days abstinent per week
Mean percent days abstinent per week at baseline 20  (21.67)
Mean percent days abstinent per week at Visit 12 76.2  (7.14)
4.Primary Outcome
Title Mean Binge Eating Episodes Per Week at Baseline vs. Visit 12
Hide Description Mean binge eating episodes per week at baseline vs. Visit 12 measured by self report on timeline follow-back (TLFB) calendars in conjunction with the subject's daily diary
Time Frame up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol
Arm/Group Title Topiramate/BBCET
Hide Arm/Group Description:
Escalating dose of up to 300 mg/day of Topiramate, plus BBCET (Brief Behavioral Compliance Enhancement Treatment)at 12 weekly visits following the initial baseline and randomization visits
Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: Binge eating episodes/week
Mean weekly binge eating episodes at baseline 3.7  (2.11)
Mean weekly binge eating episodes at Visit 12 1  (1.7)
5.Primary Outcome
Title Compliance With Study Requirements: Topiramate Level
Hide Description Number of subjects who escalated to the maximum dose of 300 mg of topiramate/day
Time Frame up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This is the number of participants who reached the dose of 300 mg of topiramate
Arm/Group Title Topiramate/BBCET
Hide Arm/Group Description:
Patients receiving an escalating dose of up to 300 mg/day of Topiramate, plus BBCET (Brief Behavioral Compliance Enhancement Treatment)
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: participants
5
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Topiramate/BBCET
Hide Arm/Group Description Escalating dose of up to 300 mg/day of Topiramate
All-Cause Mortality
Topiramate/BBCET
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Topiramate/BBCET
Affected / at Risk (%)
Total   0/5 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Topiramate/BBCET
Affected / at Risk (%)
Total   0/5 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Nassima Ait-Daoud
Organization: UVA Center for Addiction Research and Education
Phone: 434-243-0541
Responsible Party: Nassima Ait-Daoud Tiouririne, University of Virginia
ClinicalTrials.gov Identifier: NCT00300742     History of Changes
Other Study ID Numbers: 12069
First Submitted: March 7, 2006
First Posted: March 9, 2006
Results First Submitted: March 31, 2017
Results First Posted: May 11, 2017
Last Update Posted: July 12, 2017