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An Effectiveness Trial of Maintenance Therapy for Nicotine Dependence

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
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;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Nicotine Dependence
Intervention: Drug: Transdermal nicotine patch

  Participant Flow
  Hide 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
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 
Overall Participants Analyzed 
[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
  Hide 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
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


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

Responsible Party: Robert Schnoll, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01047527     History of Changes
Other Study ID Numbers: DESPR DA025078
R01DA025078-02 ( U.S. NIH Grant/Contract )
Study First Received: January 11, 2010
Results First Received: May 27, 2015
Last Updated: June 10, 2015