Trial · NCT00802412

Topiramate to Aid Smoking Cessation in Alcohol Dependent Men

NCT00802412, Phase 2, Completed, VA Office of Research and Development; results first posted 2017-01-31

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Topiramate to Aid Smoking Cessation in Alcohol Dependent Men. Trials, record NCT00802412. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00802412

On this page

Trial

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

Title: Topiramate to Aid Smoking Cessation in Alcohol Dependent Men
NCT number: NCT00802412
Status: Completed
Phases: Phase 2
Enrollment: 132 participants, actual
Lead sponsor: VA Office of Research and Development
Conditions: Nicotine Dependence, Alcohol Dependence
Interventions: Topiramate, Placebo
First posted: 2008-12-04
Last updated: 2017-01-31
Results first posted: 2017-01-31
Limitations and caveats: Dually-dependent male smokers with high rates of SUDs and psychiatric disorders, thus not generalizable to other populations; topiramate dose lower than the dose found to reduce smoking in active alcoholics; attrition may have impacted results.

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	4-week Continuous Abstinence From Smoking	Weeks 8-12 of treatment.	This measure indicates the proportion of participants who did or did not smoke any cigarettes during the final 4 weeks of treatment, which represented weeks 8-12 of study participation.
Secondary	Percent Relapsing to Any Drinking or Illicit Drug Use	12-week treatment phase, 36-week combined treatment and follow-up	Alcohol or illicit drug use during treatment or follow up.

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	4-week Continuous Abstinence From Smoking	Weeks 8-12 of treatment.		percentage of participants abstinent	NUMBER
SECONDARY	Percent Relapsing to Any Drinking or Illicit Drug Use	12-week treatment phase, 36-week combined treatment and follow-up		percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Value	Units
4-week Continuous Abstinence From Smoking	Topiramate	7.9	percentage of participants abstinent
4-week Continuous Abstinence From Smoking	Placebo	10.6	percentage of participants abstinent
Percent Relapsing to Any Drinking or Illicit Drug Use	Topiramate	31.8	percentage of participants
Percent Relapsing to Any Drinking or Illicit Drug Use	Placebo	27.3	percentage of participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Topiramate	65
Overall Study	STARTED	Placebo	67
Overall Study	COMPLETED	Topiramate	63
Overall Study	COMPLETED	Placebo	66
Overall Study	NOT COMPLETED	Topiramate	2
Overall Study	NOT COMPLETED	Placebo	1

Source ClinicalTrials.gov

Adverse events26

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	Upper respiratory infection	Respiratory, thoracic and mediastinal disorders	Topiramate	7	63	7
other	Upper respiratory infection	Respiratory, thoracic and mediastinal disorders	Placebo	13	66	13
other	Headache	General disorders	Topiramate	12	63	15
other	Headache	General disorders	Placebo	8	66	11
other	Paresthesia	Nervous system disorders	Topiramate	6	63	6
other	Paresthesia	Nervous system disorders	Placebo	12	66	12
other	Loss of appetite	General disorders	Topiramate	9	63	9
other	Loss of appetite	General disorders	Placebo	4	66	4
other	Reduced concentration	Psychiatric disorders	Topiramate	8	63	8
other	Reduced concentration	Psychiatric disorders	Placebo	6	66	6

1 to 10 of 26Source ClinicalTrials.gov

See all 26 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Topiramate
Total, all-cause mortality	Placebo
Total, other adverse events	Topiramate	46	63
Total, other adverse events	Placebo	49	66
Total, serious adverse events	Topiramate	1	63
Total, serious adverse events	Placebo	3	66

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
28029173	DERIVED

Source PubMed

Grants0

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.

None in this release.

Trial comparisons1

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

Comparison
Topiramate vs Placebo: serious adverse events

Source 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/NCT00802412

GET https://conductscience.org/api/trials/v1/NCT00802412/events?page=2

API reference For AI assistants