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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  
Number of Participants  
[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  
Annual Income (US dollars) [2]
[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  
Employment Status [3]
[units: participants]
             
Not employed     79     84     69     71     88     75     466  
Employed     136     109     158     120     132     125     780  
FTND Score [4]
[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)  
Cigarettes per day [5]
[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] Question on Demographics measure (self-report) completed at the Intake session ("What is the highest level of education you completed?").
[2] Question on Demographics measure (self-report) completed at the Intake session ("What was your household income before taxes last year?").
[3] Question on Demographics measure (self-report) completed at the Intake session ("Are you currently employed full-time or part-time for salary or wages?").
[4] 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.
[5] 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