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A Randomized Trial of Internet Access to Nicotine Patches (iQS)

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Lawrence C. An, University of Michigan
ClinicalTrials.gov Identifier:
NCT00534404
First received: September 21, 2007
Last updated: January 21, 2015
Last verified: January 2015
Results First Received: January 21, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Smoking Cessation
Tobacco Use Disorder
Interventions: Drug: Nicotine patches
Behavioral: Telephone counseling
Behavioral: iQuit Smoking website

  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
Interested individuals completed a screening survey to determine eligibility. Following study consent, participants completed two emailed surveys over the next two days and a phone confirmation call before being randomized. These check-ins confirmed the participant had valid contact information and maintained their desire to quit smoking.

Reporting Groups
  Description
NRT Patch, Phone Counseling, Internet

As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches, contingent upon participation in proactive telephone counseling. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.

Nicotine patches: Participants will wear nicotine patches.

Telephone counseling: Participants receiving telephone counseling will receive five phone calls over a 2-month period to discuss their personal smoking cessation plan.

iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website.

Nicotine Patches and Internet

As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.

Nicotine patches: Participants will wear nicotine patches.

iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website.

Internet

Research participants in this arm will have free access to internet-assisted tobacco treatment (iQuit Smoking website).

iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website.


Participant Flow:   Overall Study
    NRT Patch, Phone Counseling, Internet   Nicotine Patches and Internet   Internet
STARTED   827   830   828 
Completed at Least 1 Online Session   781   813   658 
Completed First NRT Order   765   821 [1]   0 [2] 
Completed Second NRT Order   640   789   0 [3] 
Completed at Least 1 Counseling Call   813   0 [4]   0 [4] 
1-month Follow up Completed   742   781   626 
3-month Follow up Completed   682   731   593 
COMPLETED   647   687   586 
NOT COMPLETED   180   143   242 
Death                0                0                2 
Withdrawal by Subject                8                2                38 
Removed by study staff                2                3                1 
Lost to Follow-up                170                138                201 
[1] Participants could order NRT without completing a web session
[2] NRT was not available for this arm
[3] NRT not available for this arm.
[4] There was no counseling offered in this arm



  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
NRT Patch, Phone Counseling, Internet

As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches, contingent upon participation in proactive telephone counseling. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.

Nicotine patches: Participants will wear nicotine patches.

Telephone counseling: Participants receiving telephone counseling will receive five phone calls over a 2-month period to discuss their personal smoking cessation plan.

iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website.

Nicotine Patches and Internet

As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.

Nicotine patches: Participants will wear nicotine patches.

iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website.

Internet

Research participants in this arm will have free access to internet-assisted tobacco treatment (iQuit Smoking website).

iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website.

Total Total of all reporting groups

Baseline Measures
   NRT Patch, Phone Counseling, Internet   Nicotine Patches and Internet   Internet   Total 
Overall Participants Analyzed 
[Units: Participants]
 827   830   828   2485 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   796   791   800   2387 
>=65 years   31   39   28   98 
Age 
[Units: Years]
Mean (Standard Deviation)
 44.27  (12.03)   44.31  (12.00)   44.20  (11.64)   44.26  (11.89) 
Gender 
[Units: Participants]
       
Female   562   581   578   1721 
Male   265   249   250   764 
Ethnicity (NIH/OMB) 
[Units: Participants]
       
Hispanic or Latino   30   33   33   96 
Not Hispanic or Latino   797   797   795   2389 
Unknown or Not Reported   0   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
       
American Indian or Alaska Native   5   5   6   16 
Asian   7   8   6   21 
Native Hawaiian or Other Pacific Islander   0   2   3   5 
Black or African American   56   56   64   176 
White   714   725   712   2151 
More than one race   32   23   24   79 
Unknown or Not Reported   13   11   13   37 
Region of Enrollment 
[Units: Participants]
       
United States   827   830   828   2485 
Highest education level 
[Units: Participants]
       
High school or less   236   206   201   643 
Some college   440   463   481   1384 
College graduate   151   161   146   458 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Self-reported 6-month Prolonged Abstinence From Smoking   [ Time Frame: Measured at 9 Months post-randomization ]

2.  Secondary:   Self-reported 30-day Prolonged Abstinence at 9-month Follow up   [ Time Frame: 9 months post randomization ]

3.  Secondary:   Self-reported 30-day Prolonged Abstinence at 3-month Follow up   [ Time Frame: 3-months post randomization ]


  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
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  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: Larry An, MD
Organization: University of Michigan
phone: 734-763-6099
e-mail: lcan@med.umich.edu



Responsible Party: Lawrence C. An, University of Michigan
ClinicalTrials.gov Identifier: NCT00534404     History of Changes
Other Study ID Numbers: 511
R01HL086684-01 ( US NIH Grant/Contract Award Number )
Study First Received: September 21, 2007
Results First Received: January 21, 2015
Last Updated: January 21, 2015
Health Authority: United States: Federal Government