Trial Outcomes & Findings for Financial Incentives for Smoking Cessation Among Mothers (NCT NCT05740098)
NCT ID: NCT05740098
Last Updated: 2023-07-28
Results Overview
Point prevalence abstinence will be defined as self-report of no smoking in the past 7 days, not even a puff, with biochemical verification via breath carbon monoxide (CO) and urine cotinine. Abstinence at the 12-week (end of treatment) and 24-week assessment will be compared between the three treatment arms.
COMPLETED
NA
198 participants
Collected once per woman at approximately 12- and 24- weeks following quit date in each of the three smoking arms
2023-07-28
Participant Flow
Participant milestones
| Measure |
Best Practices
Participants will receive the Five As plus a referral to a quit line.
Best Practices: Five As plus referral to a quit line
|
Best Practices and Financial Incentives
Participants will receive the Five As, a referral to a quit line, and financial incentives contingent on biochemically confirmed smoking abstinence
Best Practices: Five As plus referral to a quit line
Financial Incentives: Financial incentives provided contingent on biochemically confirmed smoking abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks following quit date.
|
Best Practices, Financial Incentives, and NRT
Participants will receive the Five As, a referral to a quit line, financial incentives contingent on biochemically confirmed smoking abstinence, and nicotine replacement therapy (NRT) provided in the form of both nicotine patches and gum/lozenge for dual therapy.
Best Practices: Five As plus referral to a quit line
Financial Incentives: Financial incentives provided contingent on biochemically confirmed smoking abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks following quit date.
Nicotine Replacement Therapy: Nicotine patches and gum/lozenge provided together for dual therapy
|
|---|---|---|---|
|
Overall Study
STARTED
|
68
|
63
|
67
|
|
Overall Study
COMPLETED
|
42
|
46
|
46
|
|
Overall Study
NOT COMPLETED
|
26
|
17
|
21
|
Reasons for withdrawal
| Measure |
Best Practices
Participants will receive the Five As plus a referral to a quit line.
Best Practices: Five As plus referral to a quit line
|
Best Practices and Financial Incentives
Participants will receive the Five As, a referral to a quit line, and financial incentives contingent on biochemically confirmed smoking abstinence
Best Practices: Five As plus referral to a quit line
Financial Incentives: Financial incentives provided contingent on biochemically confirmed smoking abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks following quit date.
|
Best Practices, Financial Incentives, and NRT
Participants will receive the Five As, a referral to a quit line, financial incentives contingent on biochemically confirmed smoking abstinence, and nicotine replacement therapy (NRT) provided in the form of both nicotine patches and gum/lozenge for dual therapy.
Best Practices: Five As plus referral to a quit line
Financial Incentives: Financial incentives provided contingent on biochemically confirmed smoking abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks following quit date.
Nicotine Replacement Therapy: Nicotine patches and gum/lozenge provided together for dual therapy
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
26
|
17
|
21
|
Baseline Characteristics
Financial Incentives for Smoking Cessation Among Mothers
Baseline characteristics by cohort
| Measure |
Best Practices
n=68 Participants
Participants will receive the Five As plus a referral to a quit line.
Best Practices: Five As plus referral to a quit line
|
Best Practices and Financial Incentives
n=63 Participants
Participants will receive the Five As, a referral to a quit line, and financial incentives contingent on biochemically confirmed smoking abstinence
Best Practices: Five As plus referral to a quit line
Financial Incentives: Financial incentives provided contingent on biochemically confirmed smoking abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks following quit date.
|
Best Practices, Financial Incentives, and NRT
n=67 Participants
Participants will receive the Five As, a referral to a quit line, financial incentives contingent on biochemically confirmed smoking abstinence, and nicotine replacement therapy (NRT) provided in the form of both nicotine patches and gum/lozenge for dual therapy.
Best Practices: Five As plus referral to a quit line
Financial Incentives: Financial incentives provided contingent on biochemically confirmed smoking abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks following quit date.
Nicotine Replacement Therapy: Nicotine patches and gum/lozenge provided together for dual therapy
|
Total
n=198 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
32.95 years
STANDARD_DEVIATION 5.86 • n=5 Participants
|
31.82 years
STANDARD_DEVIATION 6.18 • n=7 Participants
|
32.88 years
STANDARD_DEVIATION 6.50 • n=5 Participants
|
32.56 years
STANDARD_DEVIATION 6.17 • n=4 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
198 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
60 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
177 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
68 participants
n=5 Participants
|
63 participants
n=7 Participants
|
67 participants
n=5 Participants
|
198 participants
n=4 Participants
|
|
Maternal smoking status
Smoking
|
68 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
198 Participants
n=4 Participants
|
|
Maternal smoking status
non-smoker
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Collected once per woman at approximately 12- and 24- weeks following quit date in each of the three smoking armsPoint prevalence abstinence will be defined as self-report of no smoking in the past 7 days, not even a puff, with biochemical verification via breath carbon monoxide (CO) and urine cotinine. Abstinence at the 12-week (end of treatment) and 24-week assessment will be compared between the three treatment arms.
Outcome measures
| Measure |
Best Practices
n=68 Participants
Participants will receive the Five As plus a referral to a quit line.
Best Practices: Five As plus referral to a quit line
|
Best Practices and Financial Incentives
n=63 Participants
Participants will receive the Five As, a referral to a quit line, and financial incentives contingent on biochemically confirmed smoking abstinence
Best Practices: Five As plus referral to a quit line
Financial Incentives: Financial incentives provided contingent on biochemically confirmed smoking abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks following quit date.
|
Best Practices, Financial Incentives, and NRT
n=67 Participants
Participants will receive the Five As, a referral to a quit line, financial incentives contingent on biochemically confirmed smoking abstinence, and nicotine replacement therapy (NRT) provided in the form of both nicotine patches and gum/lozenge for dual therapy.
Best Practices: Five As plus referral to a quit line
Financial Incentives: Financial incentives provided contingent on biochemically confirmed smoking abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks following quit date.
Nicotine Replacement Therapy: Nicotine patches and gum/lozenge provided together for dual therapy
|
|---|---|---|---|
|
7-day Point Prevalence Smoking Abstinence Levels
12 weeks
|
4 Participants
|
22 Participants
|
18 Participants
|
|
7-day Point Prevalence Smoking Abstinence Levels
24 weeks
|
6 Participants
|
14 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: Collected twice per child at baseline, and once at approximately 6-, 12- and 24-weeks following quit datePopulation: This analysis is based on only children who submitted a baseline and at least one valid urine specimen between Weeks 6-24. Note that numbers in the Overall Participant Flow pertains to mothers while those shown in this section pertain to children.
SHSe will be defined as the level of cotinine measured in the urine of the youngest child at baseline, 6-, 12-, and 24-weeks following the mother's quit date. SHSe outcomes will be compared between the three treatment arms and between children of abstainers versus smokers independent of treatment condition. We hypothesize being able to detect greater reductions from baseline levels in the incentives compared to Best Practices treatment conditions and among abstainers compared to smokers. We report main effects of treatment condition as geometric means (+/- SEM) collapsed across the three assessment times for each treatment condition controlling for baseline values.
Outcome measures
| Measure |
Best Practices
n=52 Participants
Participants will receive the Five As plus a referral to a quit line.
Best Practices: Five As plus referral to a quit line
|
Best Practices and Financial Incentives
n=47 Participants
Participants will receive the Five As, a referral to a quit line, and financial incentives contingent on biochemically confirmed smoking abstinence
Best Practices: Five As plus referral to a quit line
Financial Incentives: Financial incentives provided contingent on biochemically confirmed smoking abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks following quit date.
|
Best Practices, Financial Incentives, and NRT
n=51 Participants
Participants will receive the Five As, a referral to a quit line, financial incentives contingent on biochemically confirmed smoking abstinence, and nicotine replacement therapy (NRT) provided in the form of both nicotine patches and gum/lozenge for dual therapy.
Best Practices: Five As plus referral to a quit line
Financial Incentives: Financial incentives provided contingent on biochemically confirmed smoking abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks following quit date.
Nicotine Replacement Therapy: Nicotine patches and gum/lozenge provided together for dual therapy
|
|---|---|---|---|
|
Objective Measure of Child Secondhand Smoke Exposure (SHSe)
|
3.53 ng/ml
Standard Error 0.96
|
3.48 ng/ml
Standard Error 0.92
|
8.49 ng/ml
Standard Error 2.22
|
SECONDARY outcome
Timeframe: 24 weeks following quit dateContinuous abstinence will be defined as self-report of no smoking in the past 7 days at each time point, not even a puff, with biochemical verification via breath CO and urine cotinine. Continuous abstinence from quit date through 24 week assessment will be compared between the three treatment arms.
Outcome measures
| Measure |
Best Practices
n=68 Participants
Participants will receive the Five As plus a referral to a quit line.
Best Practices: Five As plus referral to a quit line
|
Best Practices and Financial Incentives
n=63 Participants
Participants will receive the Five As, a referral to a quit line, and financial incentives contingent on biochemically confirmed smoking abstinence
Best Practices: Five As plus referral to a quit line
Financial Incentives: Financial incentives provided contingent on biochemically confirmed smoking abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks following quit date.
|
Best Practices, Financial Incentives, and NRT
n=67 Participants
Participants will receive the Five As, a referral to a quit line, financial incentives contingent on biochemically confirmed smoking abstinence, and nicotine replacement therapy (NRT) provided in the form of both nicotine patches and gum/lozenge for dual therapy.
Best Practices: Five As plus referral to a quit line
Financial Incentives: Financial incentives provided contingent on biochemically confirmed smoking abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks following quit date.
Nicotine Replacement Therapy: Nicotine patches and gum/lozenge provided together for dual therapy
|
|---|---|---|---|
|
Continuous Abstinence
|
3 Participants
|
12 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 48 weeks following quit datePoint prevalence abstinence will be defined as self-report of no smoking in the past 7 days, not even a puff, with biochemical verification via breath CO and urine cotinine. We will use this data to estimate relapse rates across treatment arms and for use in comparing SHSe levels in children of abstainers versus smokers.
Outcome measures
| Measure |
Best Practices
n=68 Participants
Participants will receive the Five As plus a referral to a quit line.
Best Practices: Five As plus referral to a quit line
|
Best Practices and Financial Incentives
n=63 Participants
Participants will receive the Five As, a referral to a quit line, and financial incentives contingent on biochemically confirmed smoking abstinence
Best Practices: Five As plus referral to a quit line
Financial Incentives: Financial incentives provided contingent on biochemically confirmed smoking abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks following quit date.
|
Best Practices, Financial Incentives, and NRT
n=67 Participants
Participants will receive the Five As, a referral to a quit line, financial incentives contingent on biochemically confirmed smoking abstinence, and nicotine replacement therapy (NRT) provided in the form of both nicotine patches and gum/lozenge for dual therapy.
Best Practices: Five As plus referral to a quit line
Financial Incentives: Financial incentives provided contingent on biochemically confirmed smoking abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks following quit date.
Nicotine Replacement Therapy: Nicotine patches and gum/lozenge provided together for dual therapy
|
|---|---|---|---|
|
7-day Point Prevalence Abstinence at 48-week Follow-up Assessment
|
5 Participants
|
11 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Assessed once per woman at 6-, 12-, 24-, and 48-weeks following quit date.Population: Participants who completed a valid baseline delay-discounting assessment. Six participants did not have a valid assessment making total N 192 rather than 198 participants. Analyses tested for interactions of treatment and delay discounting. If there is a significant interaction (P \< 0.05) of treatment condition and baseline delay discounting, we report results separately by treatment condition. In the absence of significant interactions, we collapse results across treatment conditions.
Biochemically-verified 7-day point-prevalence smoking abstinence.
Outcome measures
| Measure |
Best Practices
n=192 Participants
Participants will receive the Five As plus a referral to a quit line.
Best Practices: Five As plus referral to a quit line
|
Best Practices and Financial Incentives
Participants will receive the Five As, a referral to a quit line, and financial incentives contingent on biochemically confirmed smoking abstinence
Best Practices: Five As plus referral to a quit line
Financial Incentives: Financial incentives provided contingent on biochemically confirmed smoking abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks following quit date.
|
Best Practices, Financial Incentives, and NRT
Participants will receive the Five As, a referral to a quit line, financial incentives contingent on biochemically confirmed smoking abstinence, and nicotine replacement therapy (NRT) provided in the form of both nicotine patches and gum/lozenge for dual therapy.
Best Practices: Five As plus referral to a quit line
Financial Incentives: Financial incentives provided contingent on biochemically confirmed smoking abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks following quit date.
Nicotine Replacement Therapy: Nicotine patches and gum/lozenge provided together for dual therapy
|
|---|---|---|---|
|
Smoking Abstinence
# abstinent 48-wks
|
22 Participants
|
—
|
—
|
|
Smoking Abstinence
# abstinent 6-wks
|
49 Participants
|
—
|
—
|
|
Smoking Abstinence
# abstinent 12-wks
|
44 Participants
|
—
|
—
|
|
Smoking Abstinence
# abstinent 24-wks
|
32 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Collected once per woman at baseline, 6-, 12-, 24-, and 48-weeks following quit date.Population: Participants who completed a valid baseline Cigarette-Purchase-Task (CPT) assessment. Ten participants did not have a valid assessment making total N 188 rather than 198 participants. Analyses tested for interactions of treatment and CPT Latent Factors. If there is a significant interaction (P \< 0.05) of treatment condition and CPT Latent Factors, we report results separately by treatment condition. In the absence of significant interactions, we collapse results across treatment conditions.
Biochemically-verified 7-day point-prevalence smoking abstinence.
Outcome measures
| Measure |
Best Practices
n=188 Participants
Participants will receive the Five As plus a referral to a quit line.
Best Practices: Five As plus referral to a quit line
|
Best Practices and Financial Incentives
Participants will receive the Five As, a referral to a quit line, and financial incentives contingent on biochemically confirmed smoking abstinence
Best Practices: Five As plus referral to a quit line
Financial Incentives: Financial incentives provided contingent on biochemically confirmed smoking abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks following quit date.
|
Best Practices, Financial Incentives, and NRT
Participants will receive the Five As, a referral to a quit line, financial incentives contingent on biochemically confirmed smoking abstinence, and nicotine replacement therapy (NRT) provided in the form of both nicotine patches and gum/lozenge for dual therapy.
Best Practices: Five As plus referral to a quit line
Financial Incentives: Financial incentives provided contingent on biochemically confirmed smoking abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks following quit date.
Nicotine Replacement Therapy: Nicotine patches and gum/lozenge provided together for dual therapy
|
|---|---|---|---|
|
Smoking Abstinence
# abstinent 6-wks
|
49 Participants
|
—
|
—
|
|
Smoking Abstinence
# abstinent 12-wks
|
44 Participants
|
—
|
—
|
|
Smoking Abstinence
# abstinent 24-wks
|
32 Participants
|
—
|
—
|
|
Smoking Abstinence
# abstinent 48-wks
|
22 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 48 weeks following quit date.Population: Data collection on this outcome was to occur following completion of data collection on treatment outcomes. The COVID pandemic prevented data collection on this outcome.
Number of outpatient child visits will be compared between the three treatment arms and between abstainers versus smokers, independent of treatment condition.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 48 weeks following quit date.Population: Data collection on this outcome was to occur following completion of data collection on treatment outcomes. The COVID pandemic prevented data collection on this outcome.
Number of inpatient child visits will be compared between the three treatment arms and between abstainers versus smokers, independent of treatment condition.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 48 weeks following quit date.Population: Data collection on this outcome was to occur following completion of data collection on treatment outcomes. The COVID pandemic prevented data collection on this outcome.
Number of times child received prescription medications will be compared between the three treatment arms and between abstainers versus smokers, independent of treatment condition.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Study entry through 48 weeks following quit date.Population: Cost-effectiveness analysis was not conducted because data collection on necessary outcomes was not completed due to the COVID pandemic.
Cost-effectiveness will include the cost of each intervention, measured by the Brief Drug Abuse Treatment Cost Analysis Program (Brief-DATCAP) and the economic cost of treatment (fixed costs based upon proportion of time and/or space utilized by the program). Estimated treatment costs will be combined with estimated child healthcare utilization costs to represent total costs per treatment condition. Treatment costs will be compared across the three treatment arms.
Outcome measures
Outcome data not reported
Adverse Events
Best Practices
Best Practices and Financial Incentives
Best Practices, Financial Incentives, and NRT
Serious adverse events
| Measure |
Best Practices
n=68 participants at risk
Participants will receive the Five As plus a referral to a quit line.
Best Practices: Five As plus referral to a quit line
|
Best Practices and Financial Incentives
n=63 participants at risk
Participants will receive the Five As, a referral to a quit line, and financial incentives contingent on biochemically confirmed smoking abstinence
Best Practices: Five As plus referral to a quit line
Financial Incentives: Financial incentives provided contingent on biochemically confirmed smoking abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks following quit date.
|
Best Practices, Financial Incentives, and NRT
n=67 participants at risk
Participants will receive the Five As, a referral to a quit line, financial incentives contingent on biochemically confirmed smoking abstinence, and nicotine replacement therapy (NRT) provided in the form of both nicotine patches and gum/lozenge for dual therapy.
Best Practices: Five As plus referral to a quit line
Financial Incentives: Financial incentives provided contingent on biochemically confirmed smoking abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks following quit date.
Nicotine Replacement Therapy: Nicotine patches and gum/lozenge provided together for dual therapy
|
|---|---|---|---|
|
Gastrointestinal disorders
Serious Adverse event
|
0.00%
0/68 • Adverse event data were collected across 48 weeks following study entry for each participant.
|
1.6%
1/63 • Number of events 1 • Adverse event data were collected across 48 weeks following study entry for each participant.
|
0.00%
0/67 • Adverse event data were collected across 48 weeks following study entry for each participant.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place