An Effectiveness Trial of Maintenance Therapy for Nicotine Dependence

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Robert Schnoll, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01047527
First received: January 11, 2010
Last updated: June 10, 2015
Last verified: June 2015
Results First Received: May 27, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Nicotine Dependence
Intervention: Drug: Transdermal 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
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
8 Weeks Transdermal Nicotine

8 weeks of transdermal nicotine

Transdermal nicotine patch: Transdermal nicotine, 21mg/day

24 Weeks Transdermal Nicotine

24 weeks of transdermal nicotine

Transdermal nicotine patch: Transdermal nicotine, 21mg/day

52 Weeks Transdermal Nicotine

52 weeks of transdermal nicotine

Transdermal nicotine patch: Transdermal nicotine, 21mg/day


Participant Flow:   Overall Study
    8 Weeks Transdermal Nicotine     24 Weeks Transdermal Nicotine     52 Weeks Transdermal Nicotine  
STARTED     180     173     172  
8 Weeks     148     142     138  
24 Weeks     111     123     119  
COMPLETED     95     112     107  
NOT COMPLETED     85     61     65  



  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
8 Weeks Transdermal Nicotine

8 weeks of transdermal nicotine

Transdermal nicotine patch: Transdermal nicotine, 21mg/day

24 Weeks Transdermal Nicotine

24 weeks of transdermal nicotine

Transdermal nicotine patch: Transdermal nicotine, 21mg/day

52 Weeks Transdermal Nicotine

52 weeks of transdermal nicotine

Transdermal nicotine patch: Transdermal nicotine, 21mg/day

Total Total of all reporting groups

Baseline Measures
    8 Weeks Transdermal Nicotine     24 Weeks Transdermal Nicotine     52 Weeks Transdermal Nicotine     Total  
Number of Participants  
[units: participants]
  180     173     172     525  
Age  
[units: years]
Mean (Standard Deviation)
  45.9  (12.3)     46.9  (12.2)     46.4  (12.1)     46.4  (12.1)  
Gender  
[units: participants]
       
Female     90     95     81     266  
Male     90     78     91     259  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Point Prevalence Abstinence   [ Time Frame: 52-week ]

2.  Primary:   Week 24 Point Prevalence Abstinence   [ Time Frame: 24-week ]


  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
Lack of placebo; low adherence to nicotine patches; nicotine patches are not the most effective treatment for nicotine dependence; participant attrition was high.


  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. Robert Schnoll
Organization: University of Pennsylvania
phone: 215-746-7143
e-mail: schnoll@mail.med.upenn.edu


No publications provided by University of Pennsylvania

Publications automatically indexed to this study:

Responsible Party: Robert Schnoll, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01047527     History of Changes
Other Study ID Numbers: DESPR DA025078, R01DA025078-02
Study First Received: January 11, 2010
Results First Received: May 27, 2015
Last Updated: June 10, 2015
Health Authority: United States: Federal Government
United States: Food and Drug Administration