Trial Outcomes & Findings for Extended Cessation Treatment for Teen Smokers (NCT NCT00459953)
NCT ID: NCT00459953
Last Updated: 2016-05-30
Results Overview
Point prevalence abstinence is defined as a report of nonsmoking (not even a puff) for 7 consecutive days prior to assessment and an expired-air carbon monoxide level below 9 parts per million (ppm)
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
141 participants
Primary outcome timeframe
6 months
Results posted on
2016-05-30
Participant Flow
The enrollment number in the protocol section (141) differs from the number of participants started in the participant flow module (143) because 2 of those originally enrolled were discovered to be living in the same household and assigned to different treatments. Thus, they were excluded from analyses.
Participant milestones
| Measure |
Extended Treatment
extended cognitive behavioral treatment for smoking cessation; Participants receive an additional 9 sessions of cognitive behavior therapy
Extended treatment: All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The extended treatment group received an additional 9 sessions of cognitive and behavioral skills training.
|
Control Group
All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The control group received monthly follow-up phone calls for assessment purposes and to control for potential therapeutic effects associated with continued contact
|
|---|---|---|
|
Overall Study
STARTED
|
72
|
71
|
|
Overall Study
COMPLETED
|
71
|
70
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Extended Treatment
extended cognitive behavioral treatment for smoking cessation; Participants receive an additional 9 sessions of cognitive behavior therapy
Extended treatment: All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The extended treatment group received an additional 9 sessions of cognitive and behavioral skills training.
|
Control Group
All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The control group received monthly follow-up phone calls for assessment purposes and to control for potential therapeutic effects associated with continued contact
|
|---|---|---|
|
Overall Study
not analyzed-household member in study
|
1
|
1
|
Baseline Characteristics
Extended Cessation Treatment for Teen Smokers
Baseline characteristics by cohort
| Measure |
Extended Treatment
n=71 Participants
extended cognitive behavioral treatment for smoking cessation; Participants receive an additional 9 sessions of cognitive behavior therapy
Extended treatment: All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The extended treatment group received an additional 9 sessions of cognitive and behavioral skills training.
|
Control Group
n=70 Participants
All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The control group received monthly follow-up phone calls for assessment purposes and to control for potential therapeutic effects associated with continued contact
|
Total
n=141 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
71 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
141 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
88 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
47 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
97 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
71 participants
n=99 Participants
|
70 participants
n=107 Participants
|
141 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPoint prevalence abstinence is defined as a report of nonsmoking (not even a puff) for 7 consecutive days prior to assessment and an expired-air carbon monoxide level below 9 parts per million (ppm)
Outcome measures
| Measure |
Extended Treatment
n=71 Participants
extended cognitive behavioral treatment for smoking cessation; Participants receive an additional 9 sessions of cognitive behavior therapy
Extended treatment: All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The extended treatment group received an additional 9 sessions of cognitive and behavioral skills training.
|
Control Group
n=70 Participants
Monthly follow-up phone calls for assessment purposes and to control for potential therapeutic effects associated with continued contact
|
|---|---|---|
|
Point Prevalence Abstinence
|
15 participants
|
5 participants
|
Adverse Events
Extended Treatment
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Extended Treatment
n=71 participants at risk；n=72 participants at risk
extended cognitive behavioral treatment for smoking cessation; Participants receive an additional 9 sessions of cognitive behavior therapy
Extended treatment: All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The extended treatment group received an additional 9 sessions of cognitive and behavioral skills training.
|
Control Group
n=70 participants at risk；n=71 participants at risk
All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The control group received monthly follow-up phone calls for assessment purposes and to control for potential therapeutic effects associated with continued contact
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
16.9%
12/71 • Number of events 12
|
17.1%
12/70 • Number of events 12
|
|
General disorders
Lightheaded
|
15.5%
11/71 • Number of events 11
|
14.3%
10/70 • Number of events 10
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place