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

This study has been completed.
Sponsor:
Collaborator:
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  
Number of Participants  
[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


No publications provided


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