Trial Outcomes & Findings for Innovative Interventions for Smoking Cessation (NCT NCT01050569)
NCT ID: NCT01050569
Last Updated: 2019-11-18
Results Overview
Cotinine and carbon monoxide (CO) verified point prevalence abstinence
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
235 participants
Primary outcome timeframe
12 week
Results posted on
2019-11-18
Participant Flow
Oct 2008 to September 2011 Location was at the University of Minnesota Twin Cities and Duluth, Minnesota
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.
Participant milestones
| Measure |
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
79
|
76
|
80
|
|
Overall Study
COMPLETED
|
41
|
52
|
47
|
|
Overall Study
NOT COMPLETED
|
38
|
24
|
33
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
20
|
14
|
16
|
|
Overall Study
Withdrawal by Subject
|
9
|
3
|
11
|
|
Overall Study
Lack of Efficacy
|
5
|
4
|
3
|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
3
|
3
|
3
|
Baseline Characteristics
Innovative Interventions for Smoking Cessation
Baseline characteristics by cohort
| Measure |
VLNC Cigarette
n=79 Participants
Very Low Nicotine Content Cigarettes : Cigarette where the tobacco contains \<0.1 mg of nicotine yield.
|
VLNC Cigarette Plus Nicotine Patch
n=76 Participants
VLNC Cigarette Plus Nicotine Patch: 21 mg nicotine patch plus use of cigarette with tobacco containing \<0.1 mg nicotine yield.
|
Nicotine Patch
n=80 Participants
21 mg nicotine patch
|
Total
n=235 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
|
75 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
225 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Age, Continuous
|
46.5 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
47.0 years
STANDARD_DEVIATION 11.9 • n=7 Participants
|
47.3 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
47.0 years
STANDARD_DEVIATION 11.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
136 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
99 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
79 participants
n=5 Participants
|
76 participants
n=7 Participants
|
80 participants
n=5 Participants
|
235 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 weekCotinine and carbon monoxide (CO) verified point prevalence abstinence
Outcome measures
| Measure |
VLNC Cigarette
n=79 Participants
VLNC Cigarettes: Cigarette where the tobacco contains \<0.1 mg nicotine yield.
|
VLNC Cigarette Plus Nicotine Patch
n=76 Participants
Very Low Nicotine Cigarette Plus Nicotine Patch: 21 mg nicotine patch plus use of cigarette with tobacco containing \<0.1 mg nicotine yield.
|
Nicotine Patch
n=80 Participants
21 mg nicotine patch
|
|---|---|---|---|
|
End of Treatment Abstinence Rate
|
19 participants
|
18 participants
|
19 participants
|
PRIMARY outcome
Timeframe: 36 weeksCO- and cotinine-verified point prevalence abstinence
Outcome measures
| Measure |
VLNC Cigarette
n=79 Participants
VLNC Cigarettes: Cigarette where the tobacco contains \<0.1 mg nicotine yield.
|
VLNC Cigarette Plus Nicotine Patch
n=76 Participants
Very Low Nicotine Cigarette Plus Nicotine Patch: 21 mg nicotine patch plus use of cigarette with tobacco containing \<0.1 mg nicotine yield.
|
Nicotine Patch
n=80 Participants
21 mg nicotine patch
|
|---|---|---|---|
|
End of Follow-up Abstinence Rates
|
14 participants
|
15 participants
|
15 participants
|
SECONDARY outcome
Timeframe: 6 weeksOutcome measures
| Measure |
VLNC Cigarette
n=52 Participants
VLNC Cigarettes: Cigarette where the tobacco contains \<0.1 mg nicotine yield.
|
VLNC Cigarette Plus Nicotine Patch
n=55 Participants
Very Low Nicotine Cigarette Plus Nicotine Patch: 21 mg nicotine patch plus use of cigarette with tobacco containing \<0.1 mg nicotine yield.
|
Nicotine Patch
n=59 Participants
21 mg nicotine patch
|
|---|---|---|---|
|
Exposure to Tobacco Toxicants
Urinary 4-(methylnitrosamino)-1-(3-pyridyl)-1-buta
|
0.40 pmol/mg creatinine
Interval 0.29 to 0.55
|
0.26 pmol/mg creatinine
Interval 0.19 to 0.36
|
0.25 pmol/mg creatinine
Interval 0.18 to 0.34
|
|
Exposure to Tobacco Toxicants
Total Nicotine Exposure (TNE)
|
6.89 pmol/mg creatinine
Interval 4.26 to 11.02
|
27.39 pmol/mg creatinine
Interval 17.29 to 43.38
|
23.10 pmol/mg creatinine
Interval 14.59 to 36.6
|
|
Exposure to Tobacco Toxicants
Cotinine
|
2.03 pmol/mg creatinine
Interval 1.2 to 3.45
|
7.65 pmol/mg creatinine
Interval 4.59 to 12.76
|
5.50 pmol/mg creatinine
Interval 3.31 to 9.13
|
SECONDARY outcome
Timeframe: 26 weeksOutcome measures
| Measure |
VLNC Cigarette
n=78 Participants
VLNC Cigarettes: Cigarette where the tobacco contains \<0.1 mg nicotine yield.
|
VLNC Cigarette Plus Nicotine Patch
n=76 Participants
Very Low Nicotine Cigarette Plus Nicotine Patch: 21 mg nicotine patch plus use of cigarette with tobacco containing \<0.1 mg nicotine yield.
|
Nicotine Patch
n=80 Participants
21 mg nicotine patch
|
|---|---|---|---|
|
Time to Lapse or Relapse to Tobacco Use
|
2.6 weeks
Interval 1.7 to 5.9
|
7.1 weeks
Interval 6.7 to 7.7
|
2.1 weeks
Interval 1.6 to 3.9
|
Adverse Events
VLNC Cigarette
Serious events: 0 serious events
Other events: 60 other events
Deaths: 0 deaths
VLNC Cigarette Plus Nicotine Patch
Serious events: 0 serious events
Other events: 56 other events
Deaths: 0 deaths
Nicotine Patch
Serious events: 0 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
VLNC Cigarette
n=79 participants at risk
Very Low Nicotine Content Cigarettes : Cigarette where the tobacco contains \<0.1 mg of nicotine yield.
|
VLNC Cigarette Plus Nicotine Patch
n=76 participants at risk
VLNC Cigarette Plus Nicotine Patch: 21 mg nicotine patch plus use of cigarette with tobacco containing \<0.1 mg nicotine yield.
|
Nicotine Patch
n=80 participants at risk
21 mg nicotine patch
|
|---|---|---|---|
|
General disorders
Dry Mouth
|
32.9%
26/79 • Number of events 42
|
32.9%
25/76 • Number of events 55
|
17.5%
14/80 • Number of events 26
|
|
General disorders
Headaches
|
26.6%
21/79 • Number of events 26
|
27.6%
21/76 • Number of events 25
|
23.8%
19/80 • Number of events 29
|
|
Cardiac disorders
Tachycardia
|
3.8%
3/79 • Number of events 3
|
9.2%
7/76 • Number of events 7
|
8.8%
7/80 • Number of events 7
|
|
Ear and labyrinth disorders
Dizziness
|
10.1%
8/79 • Number of events 9
|
17.1%
13/76 • Number of events 13
|
16.2%
13/80 • Number of events 13
|
|
General disorders
Lightheadedness
|
13.9%
11/79 • Number of events 13
|
13.2%
10/76 • Number of events 12
|
12.5%
10/80 • Number of events 12
|
|
Gastrointestinal disorders
Nausea
|
11.4%
9/79 • Number of events 14
|
18.4%
14/76 • Number of events 18
|
17.5%
14/80 • Number of events 18
|
|
Gastrointestinal disorders
Stomach Ache
|
5.1%
4/79 • Number of events 6
|
6.6%
5/76 • Number of events 5
|
11.2%
9/80 • Number of events 13
|
|
Gastrointestinal disorders
Constipation
|
13.9%
11/79 • Number of events 15
|
13.2%
10/76 • Number of events 20
|
8.8%
7/80 • Number of events 14
|
|
Gastrointestinal disorders
Diarrhea
|
5.1%
4/79 • Number of events 4
|
9.2%
7/76 • Number of events 8
|
6.2%
5/80 • Number of events 6
|
|
General disorders
Shakiness
|
7.6%
6/79 • Number of events 6
|
7.9%
6/76 • Number of events 7
|
5.0%
4/80 • Number of events 4
|
|
General disorders
Belching
|
6.3%
5/79 • Number of events 7
|
2.6%
2/76 • Number of events 2
|
10.0%
8/80 • Number of events 10
|
|
General disorders
Sore Throat
|
17.7%
14/79 • Number of events 26
|
14.5%
11/76 • Number of events 14
|
6.2%
5/80 • Number of events 9
|
|
Psychiatric disorders
Anxiety
|
16.5%
13/79 • Number of events 15
|
7.9%
6/76 • Number of events 8
|
16.2%
13/80 • Number of events 15
|
|
General disorders
Sleep Disturbance
|
24.1%
19/79 • Number of events 28
|
50.0%
38/76 • Number of events 100
|
53.8%
43/80 • Number of events 90
|
|
Musculoskeletal and connective tissue disorders
Muscle Aches
|
7.6%
6/79 • Number of events 7
|
10.5%
8/76 • Number of events 29
|
18.8%
15/80 • Number of events 20
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place