Trial · NCT01182766

New Treatment for Alcohol and Nicotine Dependence

NCT01182766, Phase 2, Phase 3, Completed, University of Virginia; results first posted 2025-10-31

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. New Treatment for Alcohol and Nicotine Dependence. Trials, record NCT01182766. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01182766

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Trial

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

Title: New Treatment for Alcohol and Nicotine Dependence
NCT number: NCT01182766
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 236 participants, actual
Lead sponsor: University of Virginia
Conditions: Alcohol Dependence, Nicotine Dependence
Interventions: Low-Dose Topiramate, Placebo, High-Dose Topiramate
First posted: 2010-08-17
Last updated: 2025-10-31
Results first posted: 2025-10-31

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Continuous Smoking Abstinence in the Last 4 Weeks of Treatment Continuous Smoking Abstinence in the Last 4 Weeks of Treatment	Week 15 - 18 of the 18-week medication treatment	No smoking in the last 4 weeks of the 18-week treatment with an expired carbon monoxide level of \<10 ppm as the biochemical verification. We used the intent-to-treat assumption, where missing smoking data were considered as smoking.
Primary	Percentage of Heavy Drinking Days (PHDD) in the Last 4 Weeks of Treatment	Week 15 - 18 of the 18-week medication treatment	A heavy drinking day is defined as \>= 5 standard drinking units for men and \>= 4 standard drinking units for women. We calculated the PHDD used the intent-to-treat assumption, where missing drinking data were considered as heavy drinking.
Secondary	Quality of Life in the Last 4 Weeks of Treatment	Week 15 - 18 of the 18-week medication treatment	We used the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) to measure quality of life in the last 4 weeks of treatment. Scoring involves summing the individual item scores on a 5-point scale, with higher scores indicating greater life satisfaction and enjoyment (better outcome). We report here a percent score of subscales contained within the Q-LES-Q, with higher scores indicating a better outcome. The subscales within the questionnaire have different numbers of items, resulting in different ranges of raw scores, so using a percent score, which used the following formula: (raw\_score - scale\_min\_possible\_score) / (scale\_max\_possible\_score - scale\_min\_possible\_score), helped normalize such differences, improving interpretation using the same range (i.e., 0 - 100) between subscales.
Secondary	Craving for Alcohol and Cigarettes in the Last 4 Weeks of Treatment	Week 15 - 18 of the 18-week medication treatment	We used the Visual Analog Scales (VAS) to assess the craving levels for alcohol and cigarettes, respectively. VAS uses a 100 millimeter line, where 0 mm = no craving (minimum value) and 100 mm = strongest craving ever (maximum value). Participants are asked to make a mark on the line that best represents their current level of craving. Research staff then measure the distance in millimeters from the "No Craving" anchor (0 mm) to the participant's mark, which is their score. A higher score is equal to higher craving (worse outcome). Mean scores of the last 4 weeks of treatment are reported.

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Continuous Smoking Abstinence in the Last 4 Weeks of Treatment Continuous Smoking Abstinence in the Last 4 Weeks of Treatment	Week 15 - 18 of the 18-week medication treatment	participants	NUMBER
PRIMARY	Percentage of Heavy Drinking Days (PHDD) in the Last 4 Weeks of Treatment	Week 15 - 18 of the 18-week medication treatment	percentage of heavy drinking days	MEAN
SECONDARY	Quality of Life in the Last 4 Weeks of Treatment	Week 15 - 18 of the 18-week medication treatment	percent score on a scale	MEAN
SECONDARY	Craving for Alcohol and Cigarettes in the Last 4 Weeks of Treatment	Week 15 - 18 of the 18-week medication treatment	score on VAS scale	MEAN

Source ClinicalTrials.gov

Results by group33

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

Outcome	Group	Category	Value	Spread	Units
Continuous Smoking Abstinence in the Last 4 Weeks of Treatment Continuous Smoking Abstinence in the Last 4 Weeks of Treatment	Placebo		2		participants
Continuous Smoking Abstinence in the Last 4 Weeks of Treatment Continuous Smoking Abstinence in the Last 4 Weeks of Treatment	Low-Dose Topiramate		5		participants
Continuous Smoking Abstinence in the Last 4 Weeks of Treatment Continuous Smoking Abstinence in the Last 4 Weeks of Treatment	High-Dose Topiramate		6		participants
Percentage of Heavy Drinking Days (PHDD) in the Last 4 Weeks of Treatment	Placebo		62.8	Standard Deviation 45.4	percentage of heavy drinking days
Percentage of Heavy Drinking Days (PHDD) in the Last 4 Weeks of Treatment	Low-Dose Topiramate		65.1	Standard Deviation 44	percentage of heavy drinking days
Percentage of Heavy Drinking Days (PHDD) in the Last 4 Weeks of Treatment	High-Dose Topiramate		59.3	Standard Deviation 47.3	percentage of heavy drinking days
Quality of Life in the Last 4 Weeks of Treatment	Placebo	Coursework	40.2	Standard Deviation 6.9	percent score on a scale
Quality of Life in the Last 4 Weeks of Treatment	Low-Dose Topiramate	Coursework	37.1	Standard Deviation 10.3	percent score on a scale
Quality of Life in the Last 4 Weeks of Treatment	High-Dose Topiramate	Coursework	35.4	Standard Deviation 14.4	percent score on a scale
Quality of Life in the Last 4 Weeks of Treatment	Placebo	General Activities	57.7	Standard Deviation 8.7	percent score on a scale

1 to 10 of 33Source ClinicalTrials.gov

See all 33 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	84
Overall Study	STARTED	Low-Dose Topiramate	75
Overall Study	STARTED	High-Dose Topiramate	77
Overall Study	COMPLETED	Placebo	36
Overall Study	COMPLETED	Low-Dose Topiramate	35
Overall Study	COMPLETED	High-Dose Topiramate	41
Overall Study	NOT COMPLETED	Placebo	48
Overall Study	NOT COMPLETED	Low-Dose Topiramate	40
Overall Study	NOT COMPLETED	High-Dose Topiramate	36

Source ClinicalTrials.gov

Adverse events456

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	Abdominal Pain	Gastrointestinal disorders	Placebo	4	84
other	Abdominal Pain	Gastrointestinal disorders	Low-Dose Topiramate	2	75
other	Abdominal Pain	Gastrointestinal disorders	High-Dose Topiramate	0	77
other	Agitation	Psychiatric disorders	Placebo	8	84
other	Agitation	Psychiatric disorders	Low-Dose Topiramate	8	75
other	Agitation	Psychiatric disorders	High-Dose Topiramate	7	77
other	Alanine Aminotransferase Increased	Investigations	Placebo	0	84
other	Alanine Aminotransferase Increased	Investigations	Low-Dose Topiramate	1	75
other	Alanine Aminotransferase Increased	Investigations	High-Dose Topiramate	1	77
other	Alcohol Intolerance	Metabolism and nutrition disorders	Placebo	0	84

1 to 10 of 456Source ClinicalTrials.gov

See all 456 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	84
Total, all-cause mortality	Low-Dose Topiramate	0	75
Total, all-cause mortality	High-Dose Topiramate	0	77
Total, other adverse events	Placebo	63	84
Total, other adverse events	Low-Dose Topiramate	59	75
Total, other adverse events	High-Dose Topiramate	63	77
Total, serious adverse events	Placebo	8	84
Total, serious adverse events	Low-Dose Topiramate	7	75
Total, serious adverse events	High-Dose Topiramate	7	77

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
R01AA019720	New Pharmacotherapy for Alcohol and Co-morbid Disorders	AIT-DAOUD, NASSIMA; ANTHENELLI, ROBERT M; CINCIRIPINI, PAUL MICHAEL; JOHNSON, BANKOLE A	UNIVERSITY OF VIRGINIA	NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM	2010 to 2014

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.

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