Innovative Interventions for Smoking Cessation

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01050569
First received: January 14, 2010
Last updated: January 14, 2014
Last verified: January 2014
Results First Received: October 29, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Tobacco Use Disorder
Interventions: Drug: Nicotine Patch
Other: VLNC Cigarette
Other: VLNC Cigarette Plus 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
Oct 2008 to September 2011 Location was at the University of Minnesota Twin Cities and Duluth, Minnesota

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After signing consent and before randomization to groups, 44 were lost to follow-up, 17 were ineligible, 10 were no longer interested, 10 were family members of enrollees.

Reporting Groups
  Description
VLNC Cigarette Very Low Nicotine Content Cigarette: Cigarette where the tobacco contains <0.1 mg of nicotine yield. Participants were asked to smoke experimental cigarettes in an ad lib basis. Product was used for 6 weeks.
VLNC Cigarette Plus Nicotine Patch Very Low Content Cigarette Plus Nicotine Patch: 21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield. Nicotine patch was administered on a daily basis. Participants were asked to use experimental cigarettes on an ad lib basis. Products were used for 6 weeks.
Nicotine Patch Nicotine Patch: 21 mg. Nicotine patch was administered on a daily basis for a period of 6 weeks.

Participant Flow:   Overall Study
    VLNC Cigarette     VLNC Cigarette Plus Nicotine Patch     Nicotine Patch  
STARTED     79     76     80  
COMPLETED     41     52     47  
NOT COMPLETED     38     24     33  
Lost to Follow-up                 20                 14                 16  
Withdrawal by Subject                 9                 3                 11  
Lack of Efficacy                 5                 4                 3  
Adverse Event                 1                 0                 0  
Physician Decision                 3                 3                 3  



  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
VLNC Cigarette Very Low Nicotine Content Cigarettes : Cigarette where the tobacco contains <0.1 mg of nicotine yield.
VLNC Cigarette Plus Nicotine Patch VLNC Cigarette Plus Nicotine Patch: 21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield.
Nicotine Patch 21 mg nicotine patch
Total Total of all reporting groups

Baseline Measures
    VLNC Cigarette     VLNC Cigarette Plus Nicotine Patch     Nicotine Patch     Total  
Number of Participants  
[units: participants]
  79     76     80     235  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     75     74     76     225  
>=65 years     4     2     4     10  
Age  
[units: years]
Mean ± Standard Deviation
  46.5  ± 12.2     47.0  ± 11.9     47.3  ± 11.0     47.0  ± 11.7  
Gender  
[units: participants]
       
Female     47     43     46     136  
Male     32     33     34     99  
Region of Enrollment  
[units: participants]
       
United States     79     76     80     235  



  Outcome Measures
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1.  Primary:   End of Treatment Abstinence Rate   [ Time Frame: 12 week ]

2.  Primary:   End of Follow-up Abstinence Rates   [ Time Frame: 36 weeks ]

3.  Secondary:   Exposure to Tobacco Toxicants   [ Time Frame: 6 weeks ]

4.  Secondary:   Time to Lapse or Relapse to Tobacco Use   [ Time Frame: 26 weeks ]


  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
Small sample size.


  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: Dorothy Hatsukami
Organization: University of Minnesota
phone: 612 626-2121
e-mail: hatsu001@umn.edu


Publications of Results:

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01050569     History of Changes
Other Study ID Numbers: 1R01DA025598, R01DA025598, DPMC
Study First Received: January 14, 2010
Results First Received: October 29, 2013
Last Updated: January 14, 2014
Health Authority: United States: Federal Government