Trial Outcomes & Findings for A Randomized Trial of Internet Access to Nicotine Patches (NCT NCT00534404)
NCT ID: NCT00534404
Last Updated: 2015-02-03
Results Overview
Participants complete the final study survey 9 months following enrollment in the program. They are asked to report when they had last smoked a cigarette, even a puff. Participants who report that they have not smoked in the past 6 months are counted as abstinent for the purposes of our study analysis.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
2485 participants
Primary outcome timeframe
Measured at 9 Months post-randomization
Results posted on
2015-02-03
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
827
|
830
|
828
|
|
Overall Study
Completed at Least 1 Online Session
|
781
|
813
|
658
|
|
Overall Study
Completed First NRT Order
|
765
|
821
|
0
|
|
Overall Study
Completed Second NRT Order
|
640
|
789
|
0
|
|
Overall Study
Completed at Least 1 Counseling Call
|
813
|
0
|
0
|
|
Overall Study
1-month Follow up Completed
|
742
|
781
|
626
|
|
Overall Study
3-month Follow up Completed
|
682
|
731
|
593
|
|
Overall Study
COMPLETED
|
647
|
687
|
586
|
|
Overall Study
NOT COMPLETED
|
180
|
143
|
242
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
8
|
2
|
38
|
|
Overall Study
Removed by study staff
|
2
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
170
|
138
|
201
|
Baseline Characteristics
A Randomized Trial of Internet Access to Nicotine Patches
Baseline characteristics by cohort
| Measure |
NRT Patch, Phone Counseling, Internet
n=827 Participants
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
n=830 Participants
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
n=828 Participants
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
n=2485 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
796 Participants
n=5 Participants
|
791 Participants
n=7 Participants
|
800 Participants
n=5 Participants
|
2387 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
31 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
98 Participants
n=4 Participants
|
|
Age, Continuous
|
44.27 Years
STANDARD_DEVIATION 12.03 • n=5 Participants
|
44.31 Years
STANDARD_DEVIATION 12.00 • n=7 Participants
|
44.20 Years
STANDARD_DEVIATION 11.64 • n=5 Participants
|
44.26 Years
STANDARD_DEVIATION 11.89 • n=4 Participants
|
|
Sex: Female, Male
Female
|
562 Participants
n=5 Participants
|
581 Participants
n=7 Participants
|
578 Participants
n=5 Participants
|
1721 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
265 Participants
n=5 Participants
|
249 Participants
n=7 Participants
|
250 Participants
n=5 Participants
|
764 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
30 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
96 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
797 Participants
n=5 Participants
|
797 Participants
n=7 Participants
|
795 Participants
n=5 Participants
|
2389 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
56 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
176 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
714 Participants
n=5 Participants
|
725 Participants
n=7 Participants
|
712 Participants
n=5 Participants
|
2151 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
32 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
827 participants
n=5 Participants
|
830 participants
n=7 Participants
|
828 participants
n=5 Participants
|
2485 participants
n=4 Participants
|
|
Highest education level
High school or less
|
236 participants
n=5 Participants
|
206 participants
n=7 Participants
|
201 participants
n=5 Participants
|
643 participants
n=4 Participants
|
|
Highest education level
Some college
|
440 participants
n=5 Participants
|
463 participants
n=7 Participants
|
481 participants
n=5 Participants
|
1384 participants
n=4 Participants
|
|
Highest education level
College graduate
|
151 participants
n=5 Participants
|
161 participants
n=7 Participants
|
146 participants
n=5 Participants
|
458 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Measured at 9 Months post-randomizationPopulation: All currently enrolled participants were invited via email to complete an online follow-up survey. Participants who did not respond to the email received phone calls from study staff asking them to complete the survey online. Results to this outcome measure are from those subjects who completed the survey.
Participants complete the final study survey 9 months following enrollment in the program. They are asked to report when they had last smoked a cigarette, even a puff. Participants who report that they have not smoked in the past 6 months are counted as abstinent for the purposes of our study analysis.
Outcome measures
| Measure |
NRT Patch, Phone Counseling, Internet
n=647 Participants
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
n=687 Participants
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
n=586 Participants
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.
|
|---|---|---|---|
|
Self-reported 6-month Prolonged Abstinence From Smoking
|
252 participants
|
194 participants
|
109 participants
|
SECONDARY outcome
Timeframe: 9 months post randomizationOutcome measures
| Measure |
NRT Patch, Phone Counseling, Internet
n=647 Participants
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
n=687 Participants
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
n=586 Participants
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.
|
|---|---|---|---|
|
Self-reported 30-day Prolonged Abstinence at 9-month Follow up
|
310 participants
|
268 participants
|
176 participants
|
SECONDARY outcome
Timeframe: 3-months post randomizationOutcome measures
| Measure |
NRT Patch, Phone Counseling, Internet
n=682 Participants
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
n=731 Participants
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
n=593 Participants
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.
|
|---|---|---|---|
|
Self-reported 30-day Prolonged Abstinence at 3-month Follow up
|
379 participants
|
299 participants
|
138 participants
|
Adverse Events
NRT Patch, Phone Counseling, Internet
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Nicotine Patches and Internet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Internet
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NRT Patch, Phone Counseling, Internet
n=827 participants at risk
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
n=830 participants at risk
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
n=828 participants at risk
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.
|
|---|---|---|---|
|
General disorders
Death
|
0.00%
0/827 • Adverse events were collected over a 3-year period, from March 2011-March 2014
|
0.00%
0/830 • Adverse events were collected over a 3-year period, from March 2011-March 2014
|
0.24%
2/828 • Number of events 2 • Adverse events were collected over a 3-year period, from March 2011-March 2014
|
|
Cardiac disorders
Hospitalization
|
0.24%
2/827 • Number of events 2 • Adverse events were collected over a 3-year period, from March 2011-March 2014
|
0.00%
0/830 • Adverse events were collected over a 3-year period, from March 2011-March 2014
|
0.00%
0/828 • Adverse events were collected over a 3-year period, from March 2011-March 2014
|
|
General disorders
Chest pain
|
0.12%
1/827 • Number of events 1 • Adverse events were collected over a 3-year period, from March 2011-March 2014
|
0.00%
0/830 • Adverse events were collected over a 3-year period, from March 2011-March 2014
|
0.00%
0/828 • Adverse events were collected over a 3-year period, from March 2011-March 2014
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place