Trial Outcomes & Findings for An Effectiveness Trial of Maintenance Therapy for Nicotine Dependence (NCT NCT01047527)
NCT ID: NCT01047527
Last Updated: 2015-07-08
Results Overview
self-reported abstinence from smoking for 7 days prior to the assessment and biochemically confirmed with breath carbon monoxide
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
525 participants
Primary outcome timeframe
52-week
Results posted on
2015-07-08
Participant Flow
Participant milestones
| Measure |
8 Weeks Transdermal Nicotine
8 weeks of transdermal nicotine
Transdermal nicotine patch: Transdermal nicotine, 21mg/day
|
24 Weeks Transdermal Nicotine
24 weeks of transdermal nicotine
Transdermal nicotine patch: Transdermal nicotine, 21mg/day
|
52 Weeks Transdermal Nicotine
52 weeks of transdermal nicotine
Transdermal nicotine patch: Transdermal nicotine, 21mg/day
|
|---|---|---|---|
|
Overall Study
STARTED
|
180
|
173
|
172
|
|
Overall Study
8 Weeks
|
148
|
142
|
138
|
|
Overall Study
24 Weeks
|
111
|
123
|
119
|
|
Overall Study
COMPLETED
|
95
|
112
|
107
|
|
Overall Study
NOT COMPLETED
|
85
|
61
|
65
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Effectiveness Trial of Maintenance Therapy for Nicotine Dependence
Baseline characteristics by cohort
| Measure |
8 Weeks Transdermal Nicotine
n=180 Participants
8 weeks of transdermal nicotine
Transdermal nicotine patch: Transdermal nicotine, 21mg/day
|
24 Weeks Transdermal Nicotine
n=173 Participants
24 weeks of transdermal nicotine
Transdermal nicotine patch: Transdermal nicotine, 21mg/day
|
52 Weeks Transdermal Nicotine
n=172 Participants
52 weeks of transdermal nicotine
Transdermal nicotine patch: Transdermal nicotine, 21mg/day
|
Total
n=525 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45.9 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
46.9 years
STANDARD_DEVIATION 12.2 • n=7 Participants
|
46.4 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
46.4 years
STANDARD_DEVIATION 12.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
90 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
266 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
90 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
259 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 52-weekPopulation: The primary objective of this study was to examine the benefits in terms of cessation of 52-weeks of treatment compared to 8 or 24 weeks.
self-reported abstinence from smoking for 7 days prior to the assessment and biochemically confirmed with breath carbon monoxide
Outcome measures
| Measure |
Standard + Extended
n=353 Participants
participants on standard or extended therapy
|
Maintenance
n=172 Participants
Participants on 52 weeks of therapy
|
|---|---|---|
|
Point Prevalence Abstinence
|
84 participants
|
35 participants
|
PRIMARY outcome
Timeframe: 24-weekPopulation: This analysis was planned to replicate the previous study (Schnoll et al., 2010; Annals of Internal Medicine).
self-reported abstinence from smoking for 7 days prior to the assessment and biochemically confirmed with breath carbon monoxide
Outcome measures
| Measure |
Standard + Extended
n=180 Participants
participants on standard or extended therapy
|
Maintenance
n=345 Participants
Participants on 52 weeks of therapy
|
|---|---|---|
|
Week 24 Point Prevalence Abstinence
|
39 participants
|
94 participants
|
Adverse Events
8 Weeks Transdermal Nicotine
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
24 Weeks Transdermal Nicotine
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
52 Weeks Transdermal Nicotine
Serious events: 8 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
8 Weeks Transdermal Nicotine
n=180 participants at risk
8 weeks of transdermal nicotine
Transdermal nicotine patch: Transdermal nicotine, 21mg/day
|
24 Weeks Transdermal Nicotine
n=173 participants at risk
24 weeks of transdermal nicotine
Transdermal nicotine patch: Transdermal nicotine, 21mg/day
|
52 Weeks Transdermal Nicotine
n=172 participants at risk
52 weeks of transdermal nicotine
Transdermal nicotine patch: Transdermal nicotine, 21mg/day
|
|---|---|---|---|
|
Infections and infestations
Leg infection
|
0.00%
0/180 • 1 year
|
0.00%
0/173 • 1 year
|
0.58%
1/172 • Number of events 1 • 1 year
|
|
Reproductive system and breast disorders
Ovarian cysts
|
0.00%
0/180 • 1 year
|
0.58%
1/173 • Number of events 1 • 1 year
|
0.00%
0/172 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ductal Carcinoma In Situ
|
0.56%
1/180 • Number of events 1 • 1 year
|
0.00%
0/173 • 1 year
|
0.00%
0/172 • 1 year
|
|
Renal and urinary disorders
Kidney Disease
|
0.00%
0/180 • 1 year
|
0.00%
0/173 • 1 year
|
0.58%
1/172 • Number of events 1 • 1 year
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/180 • 1 year
|
0.00%
0/173 • 1 year
|
0.58%
1/172 • Number of events 1 • 1 year
|
|
Cardiac disorders
High Blood pressure/cholesterol/blood clots
|
0.00%
0/180 • 1 year
|
0.00%
0/173 • 1 year
|
0.58%
1/172 • Number of events 1 • 1 year
|
|
Cardiac disorders
COPD/Pneumonia
|
0.00%
0/180 • 1 year
|
0.00%
0/173 • 1 year
|
0.58%
1/172 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/180 • 1 year
|
0.00%
0/173 • 1 year
|
0.58%
1/172 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Kidney Stones
|
0.56%
1/180 • Number of events 1 • 1 year
|
0.00%
0/173 • 1 year
|
0.00%
0/172 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Cancer
|
0.00%
0/180 • 1 year
|
0.58%
1/173 • Number of events 1 • 1 year
|
0.00%
0/172 • 1 year
|
|
Renal and urinary disorders
Calculus of Galbladder; chlecystits; pneumonia
|
0.56%
1/180 • Number of events 1 • 1 year
|
0.00%
0/173 • 1 year
|
0.00%
0/172 • 1 year
|
|
Gastrointestinal disorders
Severe Abdominal Pain
|
0.00%
0/180 • 1 year
|
0.00%
0/173 • 1 year
|
0.58%
1/172 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Death
|
0.56%
1/180 • Number of events 1 • 1 year
|
0.00%
0/173 • 1 year
|
0.58%
1/172 • Number of events 1 • 1 year
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place