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Pharmacogenetics of Nicotine Addiction Treatment

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01314001
First received: March 10, 2011
Last updated: February 3, 2016
Last verified: February 2016
Results First Received: January 4, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Nicotine Addiction
Interventions: Drug: Varenicline
Drug: Placebo
Drug: Transdermal Nicotine

  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
The trial was conducted at four academic medical centers. From 11/16/2010 to 9/16/2013, participants were recruited through advertisements for a free smoking cessation program.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were randomly assigned to one of three treatment groups in a 1:1:1 ratio: "Placebo"; "Nicotine Patch"; or "Varenicline". Randomization was stratified by nicotine metabolite ratio - slow metabolizers of nicotine vs. normal metabolizers - and study site and blocked in blocks of 12 to maintain balance. Slow metabolizers were over-sampled.

Reporting Groups
  Description
Placebo (Slow Metabolizers)

Slow metabolizers

  • Taking placebo pills daily for 12 weeks
  • Wearing placebo patches daily for 11 weeks
  • Received smoking cessation counseling during their sessions
Placebo (Normal Metabolizers)

Normal metabolizers

  • Taking placebo pills daily for 12 weeks
  • Wearing placebo patches daily for 11 weeks
  • Received smoking cessation counseling during their sessions
Nicotine Patch (Slow Metabolizers)

Slow metabolizers

  • Taking placebo pills daily for 12 weeks
  • Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)
  • Received smoking cessation counseling during their sessions
Nicotine Patch (Normal Metabolizers)

Normal metabolizers

  • Taking placebo pills daily for 12 weeks
  • Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)
  • Received smoking cessation counseling during their sessions
Varenicline (Slow Metabolizers)

Slow metabolizers

  • Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)
  • Wearing placebo patches for 11 weeks
  • Received smoking cessation counseling during their sessions
Varenicline (Normal Metabolizers)

Normal metabolizers

  • Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)
  • Wearing placebo patches for 11 weeks
  • Received smoking cessation counseling during their sessions

Participant Flow:   Overall Study
    Placebo (Slow Metabolizers)   Placebo (Normal Metabolizers)   Nicotine Patch (Slow Metabolizers)   Nicotine Patch (Normal Metabolizers)   Varenicline (Slow Metabolizers)   Varenicline (Normal Metabolizers)
STARTED   215   193   227   191   220   200 
End-of-Treatment Visit   156   141   179   146   174   160 
6-Month Follow Up Survey   146   137   165   135   157   139 
COMPLETED   140   124   158   122   148   129 
NOT COMPLETED   75   69   69   69   72   71 



  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.
The number of subjects who began treatment period in the project (intention-to-treat).

Reporting Groups
  Description
Placebo (Slow Metabolizers)

Slow metabolizers

  • Taking placebo pills daily for 12 weeks
  • Wearing placebo patches daily for 11 weeks
  • Received smoking cessation counseling during their sessions
Placebo (Normal Metabolizers)

Normal metabolizers

  • Taking placebo pills daily for 12 weeks
  • Wearing placebo patches daily for 11 weeks
  • Received smoking cessation counseling during their sessions
Nicotine Patch (Slow Metabolizers)

Slow metabolizers

  • Taking placebo pills daily for 12 weeks
  • Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)
  • Received smoking cessation counseling during their sessions
Nicotine Patch (Normal Metabolizers)

Normal metabolizers

  • Taking placebo pills daily for 12 weeks
  • Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)
  • Received smoking cessation counseling during their sessions
Varenicline (Slow Metabolizers)

Slow metabolizers

  • Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)
  • Wearing placebo patches for 11 weeks
  • Received smoking cessation counseling during their sessions
Varenicline (Normal Metabolizers)

Normal metabolizers

  • Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)
  • Wearing placebo patches for 11 weeks
  • Received smoking cessation counseling during their sessions
Total Total of all reporting groups

Baseline Measures
   Placebo (Slow Metabolizers)   Placebo (Normal Metabolizers)   Nicotine Patch (Slow Metabolizers)   Nicotine Patch (Normal Metabolizers)   Varenicline (Slow Metabolizers)   Varenicline (Normal Metabolizers)   Total 
Overall Participants Analyzed 
[Units: Participants]
 215   193   227   191   220   200   1246 
Age 
[Units: Years]
Mean (Standard Deviation)
 44  (11)   47  (11)   46  (11)   46  (11)   44  (12)   46  (12)   45  (11) 
Gender 
[Units: Participants]
             
Female   83   91   88   94   88   99   543 
Male   132   102   139   97   132   101   703 
Race/Ethnicity, Customized 
[Units: Participants]
             
White   97   128   117   119   99   133   693 
Black   95   56   94   57   107   53   462 
Other   23   9   16   15   14   14   91 
Region of Enrollment 
[Units: Participants]
             
Canada   47   43   52   42   48   44   276 
United States   168   150   175   149   172   156   970 
Education level [1] 
[Units: Participants]
             
High school education or lower   68   57   78   49   74   61   387 
Post-high school education   147   136   149   142   146   139   859 
[1] Question on Demographics measure (self-report) completed at the Intake session ("What is the highest level of education you completed?").
Annual Income (US dollars) [1] 
[Units: Participants]
             
Greater than or equal to US$50,000   65   79   82   75   74   71   446 
Less than US$50,000   150   114   145   116   146   129   800 
[1] Question on Demographics measure (self-report) completed at the Intake session ("What was your household income before taxes last year?").
Employment Status [1] 
[Units: Participants]
             
Not employed   79   84   69   71   88   75   466 
Employed   136   109   158   120   132   125   780 
[1] Question on Demographics measure (self-report) completed at the Intake session ("Are you currently employed full-time or part-time for salary or wages?").
FTND Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 5.3  (1.92)   5.4  (2.00)   5.2  (2.00)   5.3  (1.89)   5.1  (2.00)   2.1  (2.02)   5.2  (1.97) 
[1] The Fagerstrom Test for Nicotine Dependence (FTND) is a six-item self-report scale that measures the level of nicotine dependence. Summary scores are calculated, ranging from 0 to 10, with higher scores indicating a greater difficulty quitting smoking.
Cigarettes per day [1] 
[Units: Cigarettes per day]
Mean (Standard Deviation)
 17.6  (7.0)   19.6  (8.7)   17.6  (7.0)   18.5  (7.0)   16.7  (5.4)   18.4  (6.3)   18.0  (7.0) 
[1] Self-report measure of the number of cigarettes smoked in a typical day.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   7-day Point Prevalence Quit Rate at End-of-Treatment (EOT)   [ Time Frame: Week 11 ]

2.  Secondary:   7-day Point Prevalence Quit Rate at 6-month Follow up Survey   [ Time Frame: Week 24 ]

3.  Secondary:   Total Side-Effect Severity Index at Pre-Quit   [ Time Frame: Pre-Quit (Week -1/Baseline) ]

4.  Secondary:   Total Side-Effect Severity Index at Target Quit Date   [ Time Frame: Target Quit Date (Week 0) ]

5.  Secondary:   Total Side-Effect Severity Index at Week 1   [ Time Frame: Week 1 ]

6.  Secondary:   Total Side-Effect Severity Index at Week 4   [ Time Frame: Week 4 ]


  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
A limitation is that few Hispanics or Asians were included.


  More Information
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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: Paul M. Sanborn, M.S.
Organization: University of Pennsylvania
phone: 215-746-7150
e-mail: sanborn@mail.med.upenn.edu


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

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01314001     History of Changes
Other Study ID Numbers: 811722
U01DA020830 ( US NIH Grant/Contract Award Number )
Study First Received: March 10, 2011
Results First Received: January 4, 2016
Last Updated: February 3, 2016
Health Authority: United States: Food and Drug Administration
United States: Federal Government