Trial · NCT00685178

Clinical Trial of Topiramate for Cocaine Addiction

NCT00685178, Phase 2, Completed, Johns Hopkins University; results first posted 2017-07-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Clinical Trial of Topiramate for Cocaine Addiction. Trials, record NCT00685178. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00685178

On this page

Trial

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

Title: Clinical Trial of Topiramate for Cocaine Addiction
NCT number: NCT00685178
Status: Completed
Phases: Phase 2
Enrollment: 250 participants, actual
Lead sponsor: Johns Hopkins University
Conditions: Cocaine Dependence
Interventions: topiramate, Contingency Reinforcement, placebo + NonCR
First posted: 2008-05-28
Last updated: 2017-07-11
Results first posted: 2017-07-11

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Proportion of Cocaine Positive Urine Samples Per Treatment Condition	Urine samples collected 3 times weekly from week 1 through 26	Percentage of cocaine positive urine samples as measured by Preston new use rule (50% reduction in cocaine metabolites from previous urine)
Secondary	Voucher Earnings	12 weeks (Weeks 8-20)	Voucher earnings used as a measurement of contigency management (CM) or operate conditioning. Volunteers were rewarded vouchers of escalating monetary value for cocaine abstinence, as indicated by a cocaine negative urine sample. The first cocaine negative urine earned a $2.50 voucher, and the value increased by $1.50 for each subsequent cocaine negative sample. Volunteers were awarded a bonus of $10.00 for every three consecutive cocaine negative urine samples. Urine samples were collected 3 times per week, and vouchers were attainable between Weeks 8 and 20. Contingency management as a measurement of operant conditioning in which positive reinforcement is applied (in this case vouchers of monetary value) and cocaine abstinence

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Proportion of Cocaine Positive Urine Samples Per Treatment Condition	Urine samples collected 3 times weekly from week 1 through 26	This study utilized an Intent-to-Treat (ITT) analysis. The ITT analysis includes all volunteers who signed informed consent, were randomized into the study's treatment conditions, and took at least 1 dose of study medication.	percentage of positive urine samples	NUMBER
SECONDARY	Voucher Earnings	12 weeks (Weeks 8-20)		Dollars	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
Proportion of Cocaine Positive Urine Samples Per Treatment Condition	1 Topiramate + CR	45.4		percentage of positive urine samples
Proportion of Cocaine Positive Urine Samples Per Treatment Condition	2 Topiramate + NonCR	42.7		percentage of positive urine samples
Proportion of Cocaine Positive Urine Samples Per Treatment Condition	3 Placebo + CR	53.5		percentage of positive urine samples
Proportion of Cocaine Positive Urine Samples Per Treatment Condition	4 Placebo + NonCR	46.5		percentage of positive urine samples
Voucher Earnings	1 Topiramate + CR	421.25	Standard Error 79.58	Dollars
Voucher Earnings	2 Topiramate + NonCR	343.26	Standard Error 65.34	Dollars
Voucher Earnings	3 Placebo + CR	394.69	Standard Error 72.06	Dollars
Voucher Earnings	4 Placebo + NonCR	203.51	Standard Error 50.89	Dollars

Source ClinicalTrials.gov

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	1 Topiramate + CR	40
Overall Study	STARTED	2 Topiramate + NonCR	45
Overall Study	STARTED	3 Placebo + CR	39
Overall Study	STARTED	4 Placebo + NonCR	47
Overall Study	COMPLETED	1 Topiramate + CR	27
Overall Study	COMPLETED	2 Topiramate + NonCR	26
Overall Study	COMPLETED	3 Placebo + CR	27
Overall Study	COMPLETED	4 Placebo + NonCR	33
Overall Study	NOT COMPLETED	1 Topiramate + CR	13
Overall Study	NOT COMPLETED	2 Topiramate + NonCR	19

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events52

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	Events
other	Constipation	Gastrointestinal disorders	1 Topiramate + CR	1	40	1
other	Constipation	Gastrointestinal disorders	2 Topiramate + NonCR	2	45	2
other	Constipation	Gastrointestinal disorders	3 Placebo + CR	2	39	3
other	Constipation	Gastrointestinal disorders	4 Placebo + NonCR	2	47	2
other	ECG Abnormal	Cardiac disorders	1 Topiramate + CR	1	40	1
other	ECG Abnormal	Cardiac disorders	2 Topiramate + NonCR	3	45	3
other	ECG Abnormal	Cardiac disorders	3 Placebo + CR	1	39	1
other	ECG Abnormal	Cardiac disorders	4 Placebo + NonCR	1	47	1
serious	Accidental CO Poisoning	General disorders	1 Topiramate + CR	1	40	1
serious	Accidental CO Poisoning	General disorders	2 Topiramate + NonCR	0	45	0

1 to 10 of 52Source ClinicalTrials.gov

See all 52 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	1 Topiramate + CR	0	40
Total, all-cause mortality	2 Topiramate + NonCR	0	45
Total, all-cause mortality	3 Placebo + CR	0	39
Total, all-cause mortality	4 Placebo + NonCR	0	47
Total, other adverse events	1 Topiramate + CR	1	40
Total, other adverse events	2 Topiramate + NonCR	5	45
Total, other adverse events	3 Placebo + CR	3	39
Total, other adverse events	4 Placebo + NonCR	3	47
Total, serious adverse events	1 Topiramate + CR	4	40
Total, serious adverse events	2 Topiramate + NonCR	4	45

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
24814607	DERIVED

Source PubMed

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
R01DA021808	Clinical Trial of Topiramate for Cocaine Addiction	UMBRICHT, ANNIE	JOHNS HOPKINS UNIVERSITY	NATIONAL INSTITUTE ON DRUG ABUSE	2006 to 2010

Source NIH RePORTER

Trial comparisons0

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

None in this release.

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/NCT00685178

GET https://conductscience.org/api/trials/v1/NCT00685178/events?page=2

API reference For AI assistants