Trial · NCT00167245

Topiramate for Alcohol and Cocaine Dependence

NCT00167245, Phase 2, Completed, Kyle Kampman; results first posted 2014-09-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Topiramate for Alcohol and Cocaine Dependence. Trials, record NCT00167245. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00167245

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Topiramate for Alcohol and Cocaine Dependence
NCT number: NCT00167245
Status: Completed
Phases: Phase 2
Enrollment: 170 participants, actual
Lead sponsor: Kyle Kampman
Conditions: Alcoholism, Cocaine Dependence
Interventions: Topiramate, placebo
First posted: 2005-09-14
Last updated: 2020-07-07
Results first posted: 2014-09-01
Limitations and caveats: The total number of subjects was relatively small and thus the results should be considered preliminary. The study drop-out rate was formidable, though it was comparable with most trials involving cocaine-dependent patients.

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percent of Participants Abstinent From Cocaine During Last 3 Weeks of 13 Week Trial	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.
Primary	Number of Heavy Drinking Days	13 weeks	Heavy drinking days, defined as more than 4 standard drinks for men and 3 standard drinks for women
Secondary	Cocaine Withdrawal Symptoms Measured by Cocaine Selective Severity Assessment.	13 weeks	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
Secondary	The Penn Alcohol Craving Scale	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.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percent of Participants Abstinent From Cocaine During Last 3 Weeks of 13 Week Trial	Last 3 weeks of 13 week trial		Percent of participants	NUMBER
PRIMARY	Number of Heavy Drinking Days	13 weeks		number of heavy drinking days	MEAN
SECONDARY	Cocaine Withdrawal Symptoms Measured by Cocaine Selective Severity Assessment.	13 weeks	Subjects present during the last week of the trial	score on a scale	MEAN
SECONDARY	The Penn Alcohol Craving Scale	13 weeks		score on a scale	MEAN

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Percent of Participants Abstinent From Cocaine During Last 3 Weeks of 13 Week Trial	Topirmate	17		Percent of participants
Percent of Participants Abstinent From Cocaine During Last 3 Weeks of 13 Week Trial	Placebo	6		Percent of participants
Number of Heavy Drinking Days	Topiramate	5.21	Standard Error .58	number of heavy drinking days
Number of Heavy Drinking Days	Placebo	6.10	Standard Error .61	number of heavy drinking days
Cocaine Withdrawal Symptoms Measured by Cocaine Selective Severity Assessment.	Group 1	9.9	Standard Deviation 9.5	score on a scale
Cocaine Withdrawal Symptoms Measured by Cocaine Selective Severity Assessment.	Group 2	8.4	Standard Deviation 8.8	score on a scale
The Penn Alcohol Craving Scale	Group 1	7.90	Standard Deviation 6.86	score on a scale
The Penn Alcohol Craving Scale	Group 2	9.29	Standard Deviation 6.48	score on a scale

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Topiramate	83
Overall Study	STARTED	Placebo	87
Overall Study	COMPLETED	Topiramate	54
Overall Study	COMPLETED	Placebo	46
Overall Study	NOT COMPLETED	Topiramate	29
Overall Study	NOT COMPLETED	Placebo	41

Source ClinicalTrials.gov

Adverse events8

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Sedation	General disorders	Topiramate	17	83
other	Sedation	General disorders	Placebo	15	87
other	Paresthesias	Skin and subcutaneous tissue disorders	Topiramate	17	83
other	Paresthesias	Skin and subcutaneous tissue disorders	Placebo	3	87
other	Headache	General disorders	Topiramate	6	83
other	Headache	General disorders	Placebo	3	87
other	Dry Mouth	General disorders	Topiramate	6	83
other	Dry Mouth	General disorders	Placebo	3	87

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Topiramate	0	83
Total, all-cause mortality	Placebo	0	87
Total, other adverse events	Topiramate	46	83
Total, other adverse events	Placebo	24	87
Total, serious adverse events	Topiramate	0	83
Total, serious adverse events	Placebo	0	87

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01AA014657	Topiramate for alcohol and cocaine dependence	KAMPMAN, KYLE MATTHEW	UNIVERSITY OF PENNSYLVANIA	NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM	2004 to 2008

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Topiramate vs Placebo: deaths from any cause	Trial comparisons
Topiramate vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00167245

GET https://conductscience.org/api/trials/v1/NCT00167245/registered

API reference For AI assistants