Trial Outcomes & Findings for Behavioral Activation Intervention, Reward Processing, and Youth Smoking Cessation (NCT NCT01351766)
NCT ID: NCT01351766
Last Updated: 2022-05-18
Results Overview
7 days of smoking abstinence confirmed via expired carbon monoxide at 12 weeks
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
39 participants
Primary outcome timeframe
12 weeks post quit date
Results posted on
2022-05-18
Participant Flow
Participant milestones
| Measure |
Behavioral Activation for Smoking
* Eight, 60-minute group sessions over an 8 week period
* Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking, and will continue after treatment sessions have ended
|
|---|---|
|
Overall Study
STARTED
|
39
|
|
Overall Study
COMPLETED
|
36
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Behavioral Activation Intervention, Reward Processing, and Youth Smoking Cessation
Baseline characteristics by cohort
| Measure |
Behavioral Activation for Smoking
n=39 Participants
Behavioral Activation for Smoking (BATSY) includes standard smoking cessation strategies and identifying life areas, values, and daily activities to help manage mood. Participants will complete between group exercises and will also monitor and plan daily activities in line with their values. Treatment will be delivered in 8, 60-minute group sessions over an 8-week period. Participants will also be provided 8 weeks of the transdermal nicotine patch.
Transdermal Nicotine Patch: 8 weeks of the Transdermal Nicotine Patch Nicoderm CQ at 24 hour doses of 21, 14, and 7 mg respectively depending on participant's initial level of nicotine use. Nicotine patch dose will decrease at 2 or 4 week increments also specific to participant's initial nicotine level.
|
|---|---|
|
Age, Categorical
<=18 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
20.00 years
STANDARD_DEVIATION 1.32 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks post quit date7 days of smoking abstinence confirmed via expired carbon monoxide at 12 weeks
Outcome measures
| Measure |
Behavioral Activation for Smoking
n=39 Participants
* Eight, 60-minute group sessions over an 8 week period
* Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking, and will continue after treatment sessions have ended
|
|---|---|
|
Number of Participants Smoking-Abstinent for 7 Days, 12 Weeks Post Quit Date
|
7 Participants
|
Adverse Events
Behavioral Activation for Smoking
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