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Gradual vs. Abrupt Cessation Treatment for Smoking

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
John Hughes, University of Vermont
ClinicalTrials.gov Identifier:
NCT00297492
First received: February 24, 2006
Last updated: September 7, 2012
Last verified: September 2012
History of Changes
Results First Received: May 31, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Smoking Cessation
Interventions: Behavioral: Reduction Phone Counseling
Behavioral: Abrupt Phone Counseling
Behavioral: Minimal Abrupt Phone Counseling
Drug: Pre-Quit Nicotine Lozenges
Drug: Post-Quit Nicotine Lozenges

  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
Participants were recruited using advertisements targeting smokers who wanted to quit smoking gradually. Advertisements were placed in newspapers in two cities in South Carolina and one city in New Mexico.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Enrolled sample size of 750; 4 were excluded because found to be ineligible after enrollment.

Reporting Groups
  Description
Gradual Reduction Counseling of smokers to undergo gradual reduction in cigarettes per day prior to quit date
Abrupt Cessation Counseling of smokers to set a quit date and not change cigarettes per day prior to quit date
Minimal Intervention Minimal intervention to mimic intervention at a primary care office

Participant Flow for 2 periods

 Period 1:   Set Quit Date
    Gradual Reduction     Abrupt Cessation     Minimal Intervention  
STARTED     297     299     150  
COMPLETED     290     286     145  
NOT COMPLETED     7     13     5  
Lost to Follow-up                 7                 13                 5  

Period 2:   6 Month Follow-up
    Gradual Reduction     Abrupt Cessation     Minimal Intervention  
STARTED     290     286     145  
COMPLETED     227     237     118  
NOT COMPLETED     63     49     27  
Lost to Follow-up                 63                 49                 27  



  Baseline Characteristics
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Reporting Groups
  Description
Gradual Reduction Counseling of smokers to undergo gradual reduction in cigarettes per day prior to quit date
Abrupt Cessation Counseling of smokers to set a quit date and not change cigarettes per day prior to quit date
Minimal Intervention Minimal intervention to mimic intervention at a primary care office
Total Total of all reporting groups

Baseline Measures
    Gradual Reduction     Abrupt Cessation     Minimal Intervention     Total  
Number of Participants  
[units: participants]
 		  297     299     150     746  
Age  
[units: participants]
 		       
<=18 years     0     0     0     0  
Between 18 and 65 years     273     276     139     688  
>=65 years     24     23     11     58  
Age  
[units: years]
Mean ± Standard Deviation 		  48  ± 13     48  ± 12     47  ± 13     48  ± 13  
Gender  
[units: participants]
 		       
Female     159     165     80     404  
Male     138     134     70     342  
Region of Enrollment  
[units: participants]
 		       
United States     297     299     150     746  



  Outcome Measures

1.  Primary:   Number of Participants With Prolonged Abstinence Through 6 Months Verified by Carbon Monoxide Measurement   [ Time Frame: 6 months ]
  Show Outcome Measure 1


  Serious Adverse Events
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  Other Adverse Events
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  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.


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
Our projected incidence of abstinence was higher than what was actually observed, leading to lower statistical power than expected.  


Results Point of Contact:  
Name/Title: Dr. John Hughes
Organization: University of Vermont
phone: 802-656-9610
e-mail: John.Hughes@uvm.edu


Publications of Results:


Responsible Party: John Hughes, University of Vermont
ClinicalTrials.gov Identifier: NCT00297492     History of Changes
Other Study ID Numbers: R01 DA11557-07, R01DA011557-07
Study First Received: February 24, 2006
Results First Received: May 31, 2012
Last Updated: September 7, 2012
Health Authority: United States: Federal Government