Trial Outcomes & Findings for Low-Cost Contingency Management for Smoking Cessation (NCT NCT01040260)
NCT ID: NCT01040260
Last Updated: 2018-06-06
Results Overview
Number of participants who abstained from smoking during the 7 day period verified by CO testing
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
103 participants
Primary outcome timeframe
52 weeks
Results posted on
2018-06-06
Participant Flow
Participant milestones
| Measure |
Contingency Management
Use of tangible rewards for verified abstinence
|
Counseling Plus Nicotine Patches
Counseling plus nicotine patches, carbon monoxide (CO) testing without contingency management
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
50
|
|
Overall Study
COMPLETED
|
38
|
39
|
|
Overall Study
NOT COMPLETED
|
15
|
11
|
Reasons for withdrawal
| Measure |
Contingency Management
Use of tangible rewards for verified abstinence
|
Counseling Plus Nicotine Patches
Counseling plus nicotine patches, carbon monoxide (CO) testing without contingency management
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
12
|
6
|
|
Overall Study
Lost to Follow-up
|
3
|
5
|
Baseline Characteristics
Low-Cost Contingency Management for Smoking Cessation
Baseline characteristics by cohort
| Measure |
Contingency Management
n=53 Participants
Use of tangible rewards for verified abstinence
|
Counseling Plus Nicotine Patches
n=50 Participants
Counseling plus nicotine patches, CO testing without contingency management
|
Total
n=103 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
|
|
Age, Categorical
Between 18 and 65 years
|
51 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
45.4 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
47.3 years
STANDARD_DEVIATION 12.0 • n=7 Participants
|
46.3 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
53 participants
n=5 Participants
|
50 participants
n=7 Participants
|
103 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 52 weeksNumber of participants who abstained from smoking during the 7 day period verified by CO testing
Outcome measures
| Measure |
Contingency Management
n=53 Participants
Use of tangible rewards for verified abstinence
|
Counseling Plus Nicotine Patches
n=50 Participants
Counseling plus nicotine patches, CO testing without contingency management
|
|---|---|---|
|
Abstinence Rate
|
8 participants
|
10 participants
|
Adverse Events
Contingency Management
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Counseling Plus Nicotine Patches
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Contingency Management
n=53 participants at risk
Use of tangible rewards for verified abstinence
|
Counseling Plus Nicotine Patches
n=50 participants at risk
Counseling plus nicotine patches, CO testing without contingency management
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
skin irritation
|
3.8%
2/53 • Number of events 2 • Participants are asked about adverse at each follow-up assessment visit.
|
4.0%
2/50 • Number of events 2 • Participants are asked about adverse at each follow-up assessment visit.
|
Additional Information
Dr. Timothy Carmody
University of California, San Francisco
Phone: (415) 221-4810
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place