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Topiramate to Aid Smoking Cessation in Alcohol Dependent Men

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ClinicalTrials.gov Identifier: NCT00802412
Recruitment Status : Completed
First Posted : December 4, 2008
Results First Posted : January 31, 2017
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Nicotine Dependence
Alcohol Dependence
Interventions Drug: Topiramate
Drug: Placebo
Enrollment 132
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Topiramate Placebo
Hide Arm/Group Description

The subjects for the proposed study will be 180 currently smoking, treatment-seeking male veterans with alcohol and nicotine dependence. Ninety subjects will be randomized to the topiramate arm and 90 subjects will be randomized to the placebo group.

Topiramate: Topiramate will be titrated over 5 weeks to a maximum dosage of 200 mg according to the following schedule: 25mg daily for days 1-7, 50mg daily for days 8-14, 75mg daily for days 15-21, 100mg daily for days 22-28, 150mg daily for days 29-35, 200mg daily for days 36-42. Maximum dosage will be maintained for 6 weeks, followed by a one-week taper-off period (100mg daily for 4 days and 50mg daily for 3 days).

90 participants, will receive matching placebo

Placebo: Placebo/study medication will be administered in opaque capsules in an identical fashion to maintain the double-blind study design.

Period Title: Overall Study
Started 65 67
Completed 63 66
Not Completed 2 1
Arm/Group Title Topiramate Placebo Total
Hide Arm/Group Description Received active topiramate Received placebo Total of all reporting groups
Overall Number of Baseline Participants 63 66 129
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 63 participants 66 participants 129 participants
47.2  (9.0) 46.9  (9.8) 47.0  (9.4)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 66 participants 129 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
63
 100.0%
66
 100.0%
129
 100.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Caucasian Number Analyzed 63 participants 66 participants 129 participants
32 40 72
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 63 participants 66 participants 129 participants
63 66 129
Fagerstrom   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 63 participants 66 participants 129 participants
5.4  (2.0) 6.1  (1.6) 5.8  (1.7)
[1]
Measure Description: Scores on the Fagerstrom Test for Nicotine Dependence range from 0 to 10, with higher scores indicating greater nicotine dependence.
1.Primary Outcome
Title 4-week Continuous Abstinence From Smoking
Hide Description 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.
Time Frame Weeks 8-12 of treatment.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Topiramate Placebo
Hide Arm/Group Description:
12 weeks of topiramate (up to 200 mg/day) plus smoking cessation treatment, with 24-week follow up.
12 weeks of placebo plus behavioral smoking cessation treatment, with 24 week follow up.
Overall Number of Participants Analyzed 63 66
Measure Type: Number
Unit of Measure: percentage of participants abstinent
7.9 10.6
2.Secondary Outcome
Title Percent Relapsing to Any Drinking or Illicit Drug Use
Hide Description Alcohol or illicit drug use during treatment or follow up.
Time Frame 12-week treatment phase, 36-week combined treatment and follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Topiramate Placebo
Hide Arm/Group Description:
12 weeks of topiramate (up to 200 mg/day) plus smoking cessation treatment, with 24-week follow up.
12 weeks of placebo plus behavioral smoking cessation treatment, with 24 week follow up.
Overall Number of Participants Analyzed 63 66
Measure Type: Number
Unit of Measure: percentage of participants
31.8 27.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Topiramate, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.51
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.60
Confidence Interval (2-Sided) 95%
0.4 to 6.5
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Topiramate, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .45
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.30
Confidence Interval (2-Sided) 95%
0.66 to 2.55
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Topiramate Placebo
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Topiramate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Topiramate Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/63 (1.59%)      3/66 (4.55%)    
Cardiac disorders     
atrial fibrillation  0/63 (0.00%)  0 1/66 (1.52%)  1
Psychiatric disorders     
alcohol relapse with suicidal ideation * [1]  1/63 (1.59%)  1 0/66 (0.00%)  0
alcohol relapse * [2]  0/63 (0.00%)  0 2/66 (3.03%)  2
*
Indicates events were collected by non-systematic assessment
[1]
1 participant in the topiramate group experienced an alcohol relapse that included suicidal ideation.
[2]
2 participants in the placebo group experienced relapses to alcohol
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Topiramate Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   46/63 (73.02%)      49/66 (74.24%)    
General disorders     
Headache *  12/63 (19.05%)  15 8/66 (12.12%)  11
Loss of appetite *  9/63 (14.29%)  9 4/66 (6.06%)  4
Dysgeusia *  7/63 (11.11%)  9 6/66 (9.09%)  6
Dizziness *  4/63 (6.35%)  4 7/66 (10.61%)  7
Somnolence *  6/63 (9.52%)  6 5/66 (7.58%)  5
Musculoskeletal and connective tissue disorders     
Back pain *  2/63 (3.17%)  3 7/66 (10.61%)  8
Nervous system disorders     
Paresthesia   6/63 (9.52%)  6 12/66 (18.18%)  12
Psychiatric disorders     
Reduced concentration *  8/63 (12.70%)  8 6/66 (9.09%)  6
Depression   6/63 (9.52%)  6 3/66 (4.55%)  3
Respiratory, thoracic and mediastinal disorders     
Upper respiratory infection *  7/63 (11.11%)  7 13/66 (19.70%)  13
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Neal Doran, PhD
Organization: VA San Diego
Phone: 8585528585 ext 2421
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00802412     History of Changes
Other Study ID Numbers: NEUA-003-08S
First Submitted: December 3, 2008
First Posted: December 4, 2008
Results First Submitted: September 27, 2016
Results First Posted: January 31, 2017
Last Update Posted: January 31, 2017