Trial Outcomes & Findings for Topiramate for Alcohol and Cocaine Dependence (NCT NCT00167245)

Results Overview

Samples were analyzed for benzoylecgonine by fluorescent polarization assay. Samples containing equal to or greater than 300 ng/ml of benzoylecgonine were considered to be positive for cocaine.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

170 participants

Primary outcome timeframe

Last 3 weeks of 13 week trial

Results posted on

2020-07-07

Participant Flow

Recruitment for this study began on 11/1/2004 and ended five years later in November 2009. Participants were treatment-seeking cocaine and alcohol users recruited at the UPenn Treatment Research Center.

Participant milestones

Participant milestones
Measure	Topiramate topiramate Topiramate : 300mg/day for 13 weeks	Placebo placebo : placebo pills
Overall Study STARTED	83	87
Overall Study COMPLETED	54	46
Overall Study NOT COMPLETED	29	41

Reasons for withdrawal

Reasons for withdrawal
Measure	Topiramate topiramate Topiramate : 300mg/day for 13 weeks	Placebo placebo : placebo pills
Overall Study Lost to Follow-up	20	31
Overall Study Withdrawal by Subject	5	8
Overall Study Incarcerated	3	2
Overall Study Drowsy	1	0

Baseline Characteristics

Topiramate for Alcohol and Cocaine Dependence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 n=83 Participants topiramate Topiramate : 300mg/day for 13 weeks	Group 2 n=87 Participants placebo : placebo pills	Total n=170 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	83 Participants n=99 Participants	87 Participants n=107 Participants	170 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Continuous	45 years STANDARD_DEVIATION 7.0 • n=99 Participants	43 years STANDARD_DEVIATION 8.0 • n=107 Participants	44 years STANDARD_DEVIATION 7.0 • n=206 Participants
Sex: Female, Male Female	18 Participants n=99 Participants	18 Participants n=107 Participants	36 Participants n=206 Participants
Sex: Female, Male Male	65 Participants n=99 Participants	69 Participants n=107 Participants	134 Participants n=206 Participants
Region of Enrollment United States	83 participants n=99 Participants	87 participants n=107 Participants	170 participants n=206 Participants

PRIMARY outcome

Timeframe: Last 3 weeks of 13 week trial

Samples were analyzed for benzoylecgonine by fluorescent polarization assay. Samples containing equal to or greater than 300 ng/ml of benzoylecgonine were considered to be positive for cocaine.

Outcome measures

Outcome measures
Measure	Topirmate n=83 Participants topiramate Topiramate : 300mg/day for 13 weeks	Placebo n=87 Participants placebo : placebo pills
Percent of Participants Abstinent From Cocaine During Last 3 Weeks of 13 Week Trial	17 Percent of participants	6 Percent of participants

PRIMARY outcome

Timeframe: 13 weeks

Heavy drinking days, defined as more than 4 standard drinks for men and 3 standard drinks for women

Outcome measures

Outcome measures
Measure	Topirmate n=54 Participants topiramate Topiramate : 300mg/day for 13 weeks	Placebo n=46 Participants placebo : placebo pills
Number of Heavy Drinking Days	5.21 number of heavy drinking days Standard Error .58	6.10 number of heavy drinking days Standard Error .61

SECONDARY outcome

Timeframe: 13 weeks

Population: Subjects present during the last week of the trial

Total cssa score at the end of the medication phase of the trial. The CSSA is a measure of cocaine withdrawal severity. The minimum score is 0 the maximum score is 119. Higher score means more severe cocaine withdrawal symptoms

Outcome measures

Outcome measures
Measure	Topirmate n=52 Participants topiramate Topiramate : 300mg/day for 13 weeks	Placebo n=47 Participants placebo : placebo pills
Cocaine Withdrawal Symptoms Measured by Cocaine Selective Severity Assessment.	9.9 score on a scale Standard Deviation 9.5	8.4 score on a scale Standard Deviation 8.8

SECONDARY outcome

Timeframe: 13 weeks

This Scale measures alcohol craving. The maximum score is 30, the minimum score is 0. Higher scores are indicative of more severe alcohol craving.

Outcome measures

Outcome measures
Measure	Topirmate n=83 Participants topiramate Topiramate : 300mg/day for 13 weeks	Placebo n=87 Participants placebo : placebo pills
The Penn Alcohol Craving Scale	7.90 score on a scale Standard Deviation 6.86	9.29 score on a scale Standard Deviation 6.48

Adverse Events

Topiramate

Serious events: 0 serious events

Other events: 46 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Topiramate n=83 participants at risk topiramate Topiramate : 300mg/day for 13 weeks	Placebo n=87 participants at risk placebo : placebo pills
General disorders Sedation	20.5% 17/83 • 13 weeks adverse events queried at each visit	17.2% 15/87 • 13 weeks adverse events queried at each visit
Skin and subcutaneous tissue disorders Paresthesias	20.5% 17/83 • 13 weeks adverse events queried at each visit	3.4% 3/87 • 13 weeks adverse events queried at each visit
General disorders Headache	7.2% 6/83 • 13 weeks adverse events queried at each visit	3.4% 3/87 • 13 weeks adverse events queried at each visit
General disorders Dry Mouth	7.2% 6/83 • 13 weeks adverse events queried at each visit	3.4% 3/87 • 13 weeks adverse events queried at each visit

Additional Information

Dr. Kyle Kampman

University of Pennsylvania

Phone: 2152223200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place