Trial Outcomes & Findings for Topiramate for the Treatment of Alcohol Dependent Binge-Eating Disordered Individuals (NCT NCT00300742)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

up to 12 weeks

Results posted on

2017-07-12

Participant Flow

Participants were recruited in Charlottesville and Richmond between September 2006 to February 2007.

Participant milestones

Participant milestones
Measure	Topiramate/BBCET Escalating dose of up to 300 mg/day of Topiramate
Overall Study STARTED	5
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Topiramate/BBCET n=5 Participants Escalating dose of up to 300 mg/day of Topiramate
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	45 years STANDARD_DEVIATION 10.46422 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 12 weeks

Outcome measures

Outcome measures
Measure	Topiramate/BBCET n=5 Participants Patients receiving an escalating dose of up to 300 mg/day of Topiramate, plus BBCET (Brief Behavioral Compliance Enhancement Treatment)
Compliance With Study Requirements: Attendance at Treatment Sessions Number of subjects completed through Visit 4	5 participants
Compliance With Study Requirements: Attendance at Treatment Sessions Number of subjects completed through Visit 12	3 participants

PRIMARY outcome

Timeframe: up to 24 weeks

Population: Per protocol

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

Outcome measures

Outcome measures
Measure	Topiramate/BBCET n=5 Participants Patients receiving an escalating dose of up to 300 mg/day of Topiramate, plus BBCET (Brief Behavioral Compliance Enhancement Treatment)
Mean Drinks Per Day at Baseline vs. Visit 12 Mean drinks per day at baseline	10.95 Drinks/day Standard Deviation 13.85
Mean Drinks Per Day at Baseline vs. Visit 12 Mean drinks per day at Visit 12	0.68 Drinks/day Standard Deviation 1.13

PRIMARY outcome

Timeframe: up to 24 weeks

Population: Per protocol

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

Outcome measures

Outcome measures
Measure	Topiramate/BBCET n=5 Participants Patients receiving an escalating dose of up to 300 mg/day of Topiramate, plus BBCET (Brief Behavioral Compliance Enhancement Treatment)
Mean Percent Days Abstinent Per Week at Baseline vs. Visit 12 Mean percent days abstinent per week at baseline	20 Mean percent days abstinent per week Standard Deviation 21.67
Mean Percent Days Abstinent Per Week at Baseline vs. Visit 12 Mean percent days abstinent per week at Visit 12	76.2 Mean percent days abstinent per week Standard Deviation 7.14

PRIMARY outcome

Timeframe: up to 24 weeks

Population: Per protocol

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

Outcome measures

Outcome measures
Measure	Topiramate/BBCET n=5 Participants Patients receiving an escalating dose of up to 300 mg/day of Topiramate, plus BBCET (Brief Behavioral Compliance Enhancement Treatment)
Mean Binge Eating Episodes Per Week at Baseline vs. Visit 12 Mean weekly binge eating episodes at baseline	3.7 Binge eating episodes/week Standard Deviation 2.11
Mean Binge Eating Episodes Per Week at Baseline vs. Visit 12 Mean weekly binge eating episodes at Visit 12	1 Binge eating episodes/week Standard Deviation 1.7

PRIMARY outcome

Timeframe: up to 12 weeks

Population: This is the number of participants who reached the dose of 300 mg of topiramate

Number of subjects who escalated to the maximum dose of 300 mg of topiramate/day

Outcome measures

Outcome measures
Measure	Topiramate/BBCET n=5 Participants Patients receiving an escalating dose of up to 300 mg/day of Topiramate, plus BBCET (Brief Behavioral Compliance Enhancement Treatment)
Compliance With Study Requirements: Topiramate Level	5 participants

Adverse Events

Topiramate/BBCET

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Nassima Ait-Daoud

UVA Center for Addiction Research and Education

Phone: 434-243-0541

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place