Trial Outcomes & Findings for Increasing Contingency Management Success in Smoking Cessation (NCT NCT00273793)
NCT ID: NCT00273793
Last Updated: 2012-06-21
Results Overview
COMPLETED
NA
328 participants
daily for breath CO
2012-06-21
Participant Flow
Individuals smoking at least 15 cigarettes per day that are at least 18 years old, and deliver a breath CO level greater than or equal to 15 ppm were recruited in a University setting from the general community.
Five weekdaily visits that took about 5 minutes occurred before randomization. 328 individuals consented and of these 239 completed baseline and were randomized. Which set of three study arms individuals were randomly assigned to depended on whether they successfully delivered a C) \< 3 ppm during this baseline for which they earned an incentive.
Participant milestones
| Measure |
Shaping Intervention for Hard-to-treat Smokers
Shaping intervention for hard-to-treat smokers: Smokers who did not deliver a breath CO \< 3 ppm in first five weekday sessions randomly assigned to receive incentives based upon a percentile schedule.
|
Fixed Criterion Intervention for Hard-to-treat Smokers
fixed criterion intervention for hard-to-treat smokers: Smokers who did not deliver a breath CO \< 3 ppm in first five weekday sessions randomly assigned to receive incentives for COs \< 3 ppm.
|
Non Contingent Incentives Available to Hard to Treat Smokers
Non contingent incentives available to hard to treat smokers: Smokers who did not deliver a breath CO \< 3 ppm in first five weekday sessions randomly assigned to receive incentives non-contingently on a random basis.
|
Ascending Incentives Values Used in Smokers With Early Success
Ascending incentives values used in Smokers with Early Success: Smokers who did deliver a breath CO \< 3 ppm in first five weekday sessions randomly assigned to receive incentives that escalate in value with each delivery.
|
Fixed Value Incentives Are Used in Smokers With Early Success
fixed value incentives are used in Smokers with Early Success: Smokers who did deliver a breath CO \< 3 ppm in first five weekday sessions randomly assigned to receive incentives that are fixed in value
|
Non Contingent Incentives Are Available to Smokers With Early
Non contingent incentives are available to Smokers with Early Success: Smokers who did deliver a breath CO \< 3 ppm in first five weekday sessions randomly assigned to receive incentives that are non-contingently delivered on a random basis.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
36
|
38
|
18
|
60
|
58
|
29
|
|
Overall Study
COMPLETED
|
36
|
38
|
18
|
60
|
58
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Increasing Contingency Management Success in Smoking Cessation
Baseline characteristics by cohort
| Measure |
Shaping Intervention for Hard-to-treat Smokers
n=36 Participants
Shaping intervention for hard-to-treat smokers: Smokers who did not deliver a breath CO \< 3 ppm in first five weekday sessions randomly assigned to receive incentives based upon a percentile schedule.
|
Fixed Criterion Intervention for Hard-to-treat Smokers
n=38 Participants
fixed criterion intervention for hard-to-treat smokers: Smokers who did not deliver a breath CO \< 3 ppm in first five weekday sessions randomly assigned to receive incentives for COs \< 3 ppm.
|
Non Contingent Incentives Available to Hard to Treat Smokers
n=18 Participants
Non contingent incentives available to hard to treat smokers: Smokers who did not deliver a breath CO \< 3 ppm in first five weekday sessions randomly assigned to receive incentives non-contingently on a random basis.
|
Ascending Incentives Values Used in Smokers With Early Success
n=60 Participants
Ascending incentives values used in Smokers with Early Success: Smokers who did deliver a breath CO \< 3 ppm in first five weekday sessions randomly assigned to receive incentives that escalate in value with each delivery.
|
Fixed Value Incentives Are Used in Smokers With Early Success
n=58 Participants
fixed value incentives are used in Smokers with Early Success: Smokers who did deliver a breath CO \< 3 ppm in first five weekday sessions randomly assigned to receive incentives that are fixed in value
|
Non Contingent Incentives Are Available to Smokers With Early
n=29 Participants
Non contingent incentives are available to Smokers with Early Success: Smokers who did deliver a breath CO \< 3 ppm in first five weekday sessions randomly assigned to receive incentives that are non-contingently delivered on a random basis.
|
Total
n=239 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
36 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
58 Participants
n=21 Participants
|
29 Participants
n=8 Participants
|
237 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Age Continuous
|
44.8 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
43.3 years
STANDARD_DEVIATION 12.8 • n=7 Participants
|
43.1 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
41.9 years
STANDARD_DEVIATION 12.9 • n=4 Participants
|
41.3 years
STANDARD_DEVIATION 11.8 • n=21 Participants
|
40.6 years
STANDARD_DEVIATION 10.0 • n=8 Participants
|
42.5 years
STANDARD_DEVIATION 12.0 • n=8 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
16 Participants
n=8 Participants
|
98 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
141 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=5 Participants
|
38 participants
n=7 Participants
|
18 participants
n=5 Participants
|
60 participants
n=4 Participants
|
58 participants
n=21 Participants
|
29 participants
n=8 Participants
|
239 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: daily for breath COPopulation: all subjects randomized to condition
Outcome measures
| Measure |
Shaping Intervention for Hard-to-Treat Smokers
n=36 Participants
|
Fixed Criterion Intervention for Hard-to-Treat Smokers
n=38 Participants
|
Non Contingent Incentives Available to Hard-to-Treat Smokers
n=18 Participants
|
Ascending Incentive Values Used in Smokers With Early Success
n=60 Participants
|
Fixed Value Incentives Are Used in Smokers With Early Success
n=58 Participants
|
Non Contingent Incentives Are Available to Smokers With Early
n=29 Participants
|
|---|---|---|---|---|---|---|
|
Breath Carbon Monoxide Levels Indicating Smoking Abstinence During the Study, i.e., the Number of Breath Samples With Carbon Monoxide (CO) Levels Less Than 3 Parts Per Million (Ppm)
|
2 number breath samples < 3 ppm CO
Interval 0.0 to 12.5
|
3.5 number breath samples < 3 ppm CO
Interval 0.0 to 39.0
|
0 number breath samples < 3 ppm CO
Interval 0.0 to 12.0
|
58.5 number breath samples < 3 ppm CO
Interval 15.0 to 64.0
|
49.5 number breath samples < 3 ppm CO
Interval 25.0 to 61.0
|
28 number breath samples < 3 ppm CO
Interval 6.0 to 59.0
|
SECONDARY outcome
Timeframe: past week at follow-up six months after study entryaverage number cigarettes reported smoked each day in the past week at follow up six months after study entry
Outcome measures
| Measure |
Shaping Intervention for Hard-to-Treat Smokers
n=34 Participants
|
Fixed Criterion Intervention for Hard-to-Treat Smokers
n=28 Participants
|
Non Contingent Incentives Available to Hard-to-Treat Smokers
n=14 Participants
|
Ascending Incentive Values Used in Smokers With Early Success
n=41 Participants
|
Fixed Value Incentives Are Used in Smokers With Early Success
n=43 Participants
|
Non Contingent Incentives Are Available to Smokers With Early
n=23 Participants
|
|---|---|---|---|---|---|---|
|
Average Number Cigarettes Reported Smoked Each Day in the Past Week Measured at Follow-up Six Months After Entry Into the Study
|
12.8 cigarettes per day
Standard Deviation 12.0
|
12.6 cigarettes per day
Standard Deviation 7.7
|
15.1 cigarettes per day
Standard Deviation 8.2
|
11.5 cigarettes per day
Standard Deviation 9.9
|
11.1 cigarettes per day
Standard Deviation 8.2
|
8.2 cigarettes per day
Standard Deviation 7.2
|
Adverse Events
Shaping Intervention for Hard-to-treat Smokers
Fixed Criterion Intervention for Hard-to-treat Smokers
Non Contingent Incentives Available to Hard to Treat Smokers
Ascending Incentives Values Used in Smokers With Early Success
Fixed Value Incentives Are Used in Smokers With Early Success
Non Contingent Incentives Are Available to Smokers With Early
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