Trial Outcomes & Findings for Increasing Contingency Management Success in Smoking Cessation (NCT NCT00273793)

NCT ID: NCT00273793

Last Updated: 2012-06-21

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

328 participants

Primary outcome timeframe

daily for breath CO

Results posted on

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

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

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 CO

Population: all subjects randomized to condition

Outcome measures

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 entry

average number cigarettes reported smoked each day in the past week at follow up six months after study entry

Outcome measures

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Fixed Criterion Intervention for Hard-to-treat Smokers

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Non Contingent Incentives Available to Hard to Treat Smokers

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Ascending Incentives Values Used in Smokers With Early Success

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Fixed Value Incentives Are Used in Smokers With Early Success

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Non Contingent Incentives Are Available to Smokers With Early

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

Dr. RJ Lamb

UTexas_SanAntonio

Phone: 210-567-5480

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place