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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Topiramate

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).

Placebo

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.


Participant Flow:   Overall Study
    Topiramate   Placebo
STARTED   65   67 
COMPLETED   63   66 
NOT COMPLETED   2   1 



  Baseline Characteristics

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
Topiramate Received active topiramate
Placebo Received placebo
Total Total of all reporting groups

Baseline Measures
   Topiramate   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 63   66   129 
Age 
[Units: Years]
Mean (Standard Deviation)
 47.2  (9.0)   46.9  (9.8)   47.0  (9.4) 
Gender 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      63 100.0%      66 100.0%      129 100.0% 
Race/Ethnicity, Customized 
[Units: Participants]
     
Caucasian   32   40   72 
Region of Enrollment 
[Units: Participants]
     
United States   63   66   129 
Fagerstrom [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 5.4  (2.0)   6.1  (1.6)   5.8  (1.7) 
[1] Scores on the Fagerstrom Test for Nicotine Dependence range from 0 to 10, with higher scores indicating greater nicotine dependence.


  Outcome Measures

1.  Primary:   4-week Continuous Abstinence From Smoking   [ Time Frame: Weeks 8-12 of treatment. ]

2.  Secondary:   Percent Relapsing to Any Drinking or Illicit Drug Use   [ Time Frame: 12-week treatment phase, 36-week combined treatment and follow-up ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
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.


  More Information

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
e-mail: neal.doran@va.gov


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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