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Topiramate Alone and in Combination With the Nicotine Patch for Smoking Cessation: A Pilot Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00755716
First Posted: September 19, 2008
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Center for Research Resources (NCRR)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Cheryl Oncken, UConn Health
Results First Submitted: November 10, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Tobacco Dependence
Interventions: Drug: Placebo (sugar pill)
Drug: Topiramate
Drug: Nicotine patch

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo (Sugar Pill)

Person receives an inactive placebo

Placebo (sugar pill):

Topiramate Subjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day and one week taper for a total time of 10 weeks.
Topiramate and Nicotine Patch Subjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day and one week taper for a total time of 10 weeks. On the quit date (after 2 weeks of Topiramate medication use), subjects also use 21 mg patch for 7 weeks and on week 8 subjects received 14 mg/day for 3 days then 7 mg for 4 days.

Participant Flow:   Overall Study
    Placebo (Sugar Pill)   Topiramate   Topiramate and Nicotine Patch
STARTED   19   19   19 
COMPLETED   11   11   16 
NOT COMPLETED   8   8   3 
Adverse Event                1                4                1 
Lack of Efficacy                2                0                0 
Lost to Follow-up                5                3                1 
work schedule issues                0                1                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo (Sugar Pill)

Person receives an inactive placebo

Placebo (sugar pill): patients receive

Topiramate Subjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day and one week taper for a total time of 10 weeks.
Topiramate and Nicotine Patch Subjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day and one week taper for a total time of 10 weeks.On the quit date (after 2 weeks of Topiramate medication use), subjects also use 21 mg patch for 7 weeks and on week 8 subjects received 14 mg/day for 3 days then 7 mg for 4 days.
Total Total of all reporting groups

Baseline Measures
   Placebo (Sugar Pill)   Topiramate   Topiramate and Nicotine Patch   Total 
Overall Participants Analyzed 
[Units: Participants]
 19   19   19   57 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      19 100.0%      19 100.0%      19 100.0%      57 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 45.4  (7.6)   46.1  (11.1)   50.1  (9.6)   47.2  (9.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      11  57.9%      10  52.6%      13  68.4%      34  59.6% 
Male      8  42.1%      9  47.4%      6  31.6%      23  40.4% 
Region of Enrollment 
[Units: Participants]
Count of Participants
       
United States   19   19   19   57 


  Outcome Measures
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1.  Primary:   Primary Outcome is 4-week Continuous Quit Rate at the End of Treatment.   [ Time Frame: weeks 7-10 ]

2.  Secondary:   MNWS   [ Time Frame: Measured weekly during weeks 7-10 & the mean of weekly measurements is recorded. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Cheryl Oncken
Organization: UConn Health
phone: 860-679-3425
e-mail: oncken@uchc.edu


Publications of Results:

Responsible Party: Cheryl Oncken, UConn Health
ClinicalTrials.gov Identifier: NCT00755716     History of Changes
Other Study ID Numbers: 06-114-1
5M01RR006192 ( U.S. NIH Grant/Contract )
K24AA013736 ( U.S. NIH Grant/Contract )
First Submitted: September 18, 2008
First Posted: September 19, 2008
Results First Submitted: November 10, 2016
Results First Posted: August 16, 2017
Last Update Posted: October 12, 2017