Trial Outcomes & Findings for Internet-Administered Smoking Cessation Treatment for Overweight and Obese Smokers (NCT NCT01259466)
NCT ID: NCT01259466
Last Updated: 2015-09-28
Results Overview
Continuous abstinence during the last 14 days of treatment, confirmed by biologically verified abstinence (CO level \<10ppm)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
54 participants
Primary outcome timeframe
Post-treatment (12-weeks)
Results posted on
2015-09-28
Participant Flow
Participant milestones
| Measure |
Cognitive Behavioral Treatment + Nicotine Replacement
Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
|
Health Education + Nicotine Replacement
Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
27
|
|
Overall Study
COMPLETED
|
26
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
9
|
Reasons for withdrawal
| Measure |
Cognitive Behavioral Treatment + Nicotine Replacement
Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
|
Health Education + Nicotine Replacement
Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
9
|
Baseline Characteristics
Internet-Administered Smoking Cessation Treatment for Overweight and Obese Smokers
Baseline characteristics by cohort
| Measure |
Cognitive Behavioral Treatment + Nicotine Replacement
n=27 Participants
Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
|
Health Education + Nicotine Replacement
n=27 Participants
Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
54 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
46.4 years
STANDARD_DEVIATION 11.6 • n=93 Participants
|
45.4 years
STANDARD_DEVIATION 9.6 • n=4 Participants
|
45.9 years
STANDARD_DEVIATION 10.5 • n=27 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=93 Participants
|
27 participants
n=4 Participants
|
54 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Post-treatment (12-weeks)Continuous abstinence during the last 14 days of treatment, confirmed by biologically verified abstinence (CO level \<10ppm)
Outcome measures
| Measure |
Cognitive Behavioral Treatment + Nicotine Replacement
n=27 Participants
Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
|
Health Education + Nicotine Replacement
n=27 Participants
Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
|
|---|---|---|
|
Number of Participants With Verified Smoking Cessation (Abstinence)
|
7 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Post-treatment (12 weeks)% Weight change: ((post-treatment weight - pre-treatment weight)/ pre-treatment weight) \* 100
Outcome measures
| Measure |
Cognitive Behavioral Treatment + Nicotine Replacement
n=26 Participants
Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
|
Health Education + Nicotine Replacement
n=18 Participants
Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
|
|---|---|---|
|
Percent Weight Change
|
1.47 Percent weight change
Standard Deviation 2.9
|
1.79 Percent weight change
Standard Deviation 2.8
|
Adverse Events
Cognitive Behavioral Treatment + Nicotine Replacement
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Health Education + Nicotine Replacement
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place