Trial Outcomes & Findings for Small Financial Incentives to Promote Smoking Cessation (NCT NCT02737566)
NCT ID: NCT02737566
Last Updated: 2024-07-17
Results Overview
The primary outcome measure is carbon monoxide (CO)-verified 7-day point prevalence abstinence at 26 weeks post-quit (intent-to-treat; missing=smoking).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
320 participants
Primary outcome timeframe
26 weeks post-quit
Results posted on
2024-07-17
Participant Flow
Participant milestones
| Measure |
Standard Care + Financial Incentives
Participants randomized to Standard Care + Financial Incentives for Abstinence will be offered smoking cessation counseling and pharmacotherapy (standard care) and they will have the opportunity to earn small gift cards for biochemically-verified abstinence through 12 weeks post-quit. The amount of the gift cards will escalate each week from the quit date through 4 weeks post-quit with continuous abstinence. Participants who are non-abstinent at any visit may earn incentives for abstinence at the next visit, but the amount will reset to the starting level. Participants may additionally earn an additional gift card for abstinence at the 8 and 12 weeks post-quit visits.
Standard Care + Financial Incentives: Tobacco cessation counseling plus pharmacotherapy and financial incentives for quitting.
|
Standard Care
Participants randomized to Standard Care will be offered weekly smoking cessation counseling and pharmacotherapy.
Standard Care: Tobacco cessation counseling plus pharmacotherapy.
|
|---|---|---|
|
Overall Study
STARTED
|
159
|
161
|
|
Overall Study
COMPLETED
|
104
|
105
|
|
Overall Study
NOT COMPLETED
|
55
|
56
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Missing age for 1 participant.
Baseline characteristics by cohort
| Measure |
Standard Care + Financial Incentives
n=159 Participants
Participants randomized to Standard Care + Financial Incentives for Abstinence will be offered smoking cessation counseling and pharmacotherapy (standard care) and they will have the opportunity to earn small gift cards for biochemically-verified abstinence through 12 weeks post-quit. The amount of the gift cards will escalate each week from the quit date through 4 weeks post-quit with continuous abstinence. Participants who are non-abstinent at any visit may earn incentives for abstinence at the next visit, but the amount will reset to the starting level. Participants may additionally earn an additional gift card for abstinence at the 8 and 12 weeks post-quit visits.
Standard Care + Financial Incentives: Tobacco cessation counseling plus pharmacotherapy and financial incentives for quitting.
|
Standard Care
n=161 Participants
Participants randomized to Standard Care will be offered weekly smoking cessation counseling and pharmacotherapy.
Standard Care: Tobacco cessation counseling plus pharmacotherapy.
|
Total
n=320 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.0 years
STANDARD_DEVIATION 11.1 • n=158 Participants • Missing age for 1 participant.
|
48.9 years
STANDARD_DEVIATION 12.2 • n=161 Participants • Missing age for 1 participant.
|
48.9 years
STANDARD_DEVIATION 11.6 • n=319 Participants • Missing age for 1 participant.
|
|
Sex: Female, Male
Female
|
106 Participants
n=159 Participants
|
96 Participants
n=161 Participants
|
202 Participants
n=320 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=159 Participants
|
65 Participants
n=161 Participants
|
118 Participants
n=320 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=159 Participants
|
8 Participants
n=161 Participants
|
15 Participants
n=320 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
152 Participants
n=159 Participants
|
153 Participants
n=161 Participants
|
305 Participants
n=320 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=159 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=320 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
9 Participants
n=159 Participants
|
4 Participants
n=161 Participants
|
13 Participants
n=320 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=159 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=320 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=159 Participants
|
1 Participants
n=161 Participants
|
2 Participants
n=320 Participants
|
|
Race (NIH/OMB)
Black or African American
|
36 Participants
n=159 Participants
|
46 Participants
n=161 Participants
|
82 Participants
n=320 Participants
|
|
Race (NIH/OMB)
White
|
101 Participants
n=159 Participants
|
99 Participants
n=161 Participants
|
200 Participants
n=320 Participants
|
|
Race (NIH/OMB)
More than one race
|
12 Participants
n=159 Participants
|
11 Participants
n=161 Participants
|
23 Participants
n=320 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=159 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=320 Participants
|
|
Region of Enrollment
United States
|
159 participants
n=159 Participants
|
161 participants
n=161 Participants
|
320 participants
n=320 Participants
|
|
Cigarettes Smoked Per Day (pre-quit)
|
19.1 Cigarettes smoked per day
STANDARD_DEVIATION 10.2 • n=158 Participants • Missing cigarettes smoked per day for 1 participant.
|
19.2 Cigarettes smoked per day
STANDARD_DEVIATION 10.1 • n=161 Participants • Missing cigarettes smoked per day for 1 participant.
|
19.1 Cigarettes smoked per day
STANDARD_DEVIATION 10.1 • n=319 Participants • Missing cigarettes smoked per day for 1 participant.
|
PRIMARY outcome
Timeframe: 26 weeks post-quitThe primary outcome measure is carbon monoxide (CO)-verified 7-day point prevalence abstinence at 26 weeks post-quit (intent-to-treat; missing=smoking).
Outcome measures
| Measure |
Standard Care + Financial Incentives
n=159 Participants
Participants randomized to Standard Care + Financial Incentives for Abstinence will be offered smoking cessation counseling and pharmacotherapy (standard care) and they will have the opportunity to earn small gift cards for biochemically-verified abstinence through 12 weeks post-quit. The amount of the gift cards will escalate each week from the quit date through 4 weeks post-quit with continuous abstinence. Participants who are non-abstinent at any visit may earn incentives for abstinence at the next visit, but the amount will reset to the starting level. Participants may additionally earn an additional gift card for abstinence at the 8 and 12 weeks post-quit visits.
Standard Care + Financial Incentives: Tobacco cessation counseling plus pharmacotherapy and financial incentives for quitting.
|
Standard Care
n=161 Participants
Participants randomized to Standard Care will be offered weekly smoking cessation counseling and pharmacotherapy.
Standard Care: Tobacco cessation counseling plus pharmacotherapy.
|
|---|---|---|
|
Biochemically-verified Smoking Cessation
|
22 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 12 weeks post-quitThe secondary outcome measure is Carbon Monoxide (CO)-verified 7-day point prevalence abstinence at 12 weeks post-quit (intent-to-treat; missing=smoking).
Outcome measures
| Measure |
Standard Care + Financial Incentives
n=159 Participants
Participants randomized to Standard Care + Financial Incentives for Abstinence will be offered smoking cessation counseling and pharmacotherapy (standard care) and they will have the opportunity to earn small gift cards for biochemically-verified abstinence through 12 weeks post-quit. The amount of the gift cards will escalate each week from the quit date through 4 weeks post-quit with continuous abstinence. Participants who are non-abstinent at any visit may earn incentives for abstinence at the next visit, but the amount will reset to the starting level. Participants may additionally earn an additional gift card for abstinence at the 8 and 12 weeks post-quit visits.
Standard Care + Financial Incentives: Tobacco cessation counseling plus pharmacotherapy and financial incentives for quitting.
|
Standard Care
n=161 Participants
Participants randomized to Standard Care will be offered weekly smoking cessation counseling and pharmacotherapy.
Standard Care: Tobacco cessation counseling plus pharmacotherapy.
|
|---|---|---|
|
Biochemically-verified Smoking Cessation
|
45 Participants
|
18 Participants
|
Adverse Events
Standard Care + Financial Incentives
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Standard Care
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 |
Standard Care + Financial Incentives
n=159 participants at risk
Participants randomized to Standard Care + Financial Incentives for Abstinence will be offered smoking cessation counseling and pharmacotherapy (standard care) and they will have the opportunity to earn small gift cards for biochemically-verified abstinence through 12 weeks post-quit. The amount of the gift cards will escalate each week from the quit date through 4 weeks post-quit with continuous abstinence. Participants who are non-abstinent at any visit may earn incentives for abstinence at the next visit, but the amount will reset to the starting level. Participants may additionally earn an additional gift card for abstinence at the 8 and 12 weeks post-quit visits.
Standard Care + Financial Incentives: Tobacco cessation counseling plus pharmacotherapy and financial incentives for quitting.
|
Standard Care
n=161 participants at risk
Participants randomized to Standard Care will be offered weekly smoking cessation counseling and pharmacotherapy.
Standard Care: Tobacco cessation counseling plus pharmacotherapy.
|
|---|---|---|
|
Renal and urinary disorders
Blood in Urine
|
0.00%
0/159 • 27 weeks (1 week pre-quit-date through 26 weeks post-quit-date)
|
0.62%
1/161 • 27 weeks (1 week pre-quit-date through 26 weeks post-quit-date)
|
|
Product Issues
Fatigue
|
0.63%
1/159 • 27 weeks (1 week pre-quit-date through 26 weeks post-quit-date)
|
0.00%
0/161 • 27 weeks (1 week pre-quit-date through 26 weeks post-quit-date)
|
|
Social circumstances
Dissatisfaction with compensation
|
0.63%
1/159 • 27 weeks (1 week pre-quit-date through 26 weeks post-quit-date)
|
0.00%
0/161 • 27 weeks (1 week pre-quit-date through 26 weeks post-quit-date)
|
|
Social circumstances
Study smartphone was stolen
|
0.00%
0/159 • 27 weeks (1 week pre-quit-date through 26 weeks post-quit-date)
|
0.62%
1/161 • 27 weeks (1 week pre-quit-date through 26 weeks post-quit-date)
|
Additional Information
Dr. Darla Kendzor
The University of Oklahoma Health Sciences Center
Phone: (405) 271-8001
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place