Tobacco Use DisorderNCT03922360
Smartphone-based Financial Incentives
A study testing Smartphone-based Financial Incentives and Best Practices in people with Tobacco Use Disorder, run by University of Vermont at 1 site in United States.
Trial summary
Cigarette smoking during pregnancy increases risk for catastrophic pregnancy complications, growth retardation, other adverse fetal and infant health problems, and later-in-life chronic conditions among exposed offspring. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Smartphone-based Financial Incentives and Best Practices
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 16 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- > 18 years of age
- report being smokers at the time they learned of the current pregnancy
- report smoking in the 7 days prior to completing their preliminary eligibility screening,
- < 25 weeks pregnant
- speak English
- own a smartphone
Who cannot join
- current or prior mental or medical condition that may interfere with study participation (assessed via self-report during formal intake assessment completed online or by phone using a medical and psychosocial history questionnaire)
- smoke marijuana more than once each week and not willing to quit (marijuana smoking can inflate breath CO)
- exposed to unavoidable occupational sources of CO (e.g., car mechanic)
- report currently receiving opioid maintenance therapy (e.g., methadone, buprenorphine).
Trial locations and contacts
1 site in 1 country.
About this study
Cigarette smoking during pregnancy increases risk for catastrophic pregnancy complications, growth retardation, other adverse fetal and infant health problems, and later-in-life chronic conditions among exposed offspring. The most effective intervention for reducing smoking during pregnancy is financial incentives whereby participants earn incentives (e.g., gift cards, cash) contingent on objective evidence of smoking abstinence. However, financial incentives-based interventions are typically delivered in relatively intense protocols requiring frequent clinic visits, which limits the geographical range over which services can be delivered and potentially denies treatment to those residing in remote or otherwise difficult to reach settings.
The present study will examine the feasibility, efficacy, and cost-effectiveness of a smartphone-based financial incentives intervention whereby smoking monitoring and delivery of incentives are completed remotely using a mobile app (to be designed by DynamiCare Health, Inc.). Eligible participants who complete the informed consent process will be randomized to one of two conditions: an incentives condition wherein women will receive financial incentives contingent on the remote submission of breath and saliva specimens indicating abstinence from recent smoking (described below), or a best practices control condition in which women will receive usual care for smoking cessation that is provided at their obstetrical clinics, as well as three brief educational sessions and referral to the Vermont (or other state) pregnancy-specific quit line by our research staff.
Read more
For inclusion in the study, women must meet the following criteria: (a) > 18 years of age, (b) report being smokers at the time they learned of the current pregnancy, (c) report smoking in the 7 days prior to completing their phone eligibility screening, (c) < 25 weeks pregnant, (d) speak English, (e) own a smartphone (Android or iOS; 81.8% of pregnant women in wave 1 [2013-2014] of the Population Assessment of Tobacco and Health [PATH] reported owning a smartphone). Exclusion criteria include: (a) current or prior mental or medical condition that may interfere with study participation (assessed via self-report during phone eligibility screening), (b) smoke marijuana more than once each week and not willing to quit (marijuana smoking can inflate breath CO), (c) exposed to unavoidable occupational sources of CO (e.g., car mechanic), and (d) self-report currently being maintained on opioid maintenance therapy (e.g., methadone, buprenorphine).
Participants randomized to the incentives condition will select a quit date (either the first or second Monday following their enrollment), and will submit videos of themselves blowing into a breath CO monitor twice daily during week 1. They will receive incentives for every sample where expired breath CO is < 6 ppm. Beginning in week 2 and extending through week 6, participants will submit videos twice per week (Monday/Thursday) for which they will receive incentives for providing videos of themselves completing saliva cotinine tests indicating smoking abstinence. From week 7 until delivery, participants will submit videos once per week and will continue to receive incentives for saliva cotinine tests indicating no smoking. During the postpartum period, women will submit videos twice weekly for the first 4 weeks and once weekly from weeks 5-12. Women will receiving incentives for negative breath and saliva samples, and the value of incentives will increase with each consecutive sample indicating smoking abstinence. Participants will not receive incentives for missed samples or samples that indicate smoking, and the incentive schedule will be reset at its starting value. However two consecutive negative samples following a missed or positive sample will restore the incentive to its prior value.
Women in both conditions will complete seven formal assessments of their smoking status during their participation along with a treatment acceptability questionnaire and semi-structured interview on barriers and facilitators of treatment engagement.
We conducted a power analysis to estimate the number of participants required to detect treatment effects assuming late-pregnancy abstinence rates of approximately 40% vs. < 10% (incentives vs. best practices, respectively), and 24-week postpartum abstinence rates of approximately 20% vs. < 5%. The proposed sample size of 76 per treatment condition will result in at least 80% power to detect a difference between the two treatment conditions in abstinence rates of 40% vs. 10 % at late-pregnancy or 20% vs. 5% at 24-weeks postpartum assessments using a chi-square test and significance level of 0.05.
- Conditions
- Tobacco Use Disorder
- Being tested
- Smartphone-based Financial Incentives, Best Practices
- Keywords
- Nicotine Dependence, Financial Incentives, Pregnant Women, Smoking Cessation, mHealth, Smartphone
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone-based Financial IncentivesBehavioural
Also called Contingency Management
Best Practices- The 2008 Clinical Practice Guidelines for smoking cessation recommends that pregnant smokers be provided with the 5As. Research staff will implement the 5As at three assessments that take place during pregnancy.
Best Practices + Financial Incentive- Women assigned to this condition will receive the best practices treatment described above plus the remote incentives intervention.
Beginning on the quit date and extending for one week, participants will be required to submit twice daily CO samples. All samples < 6 ppm will be considered negative and those > 6 ppm will be considered positive. Participants will earn incentives for breath tests indicating smoking abstinence, and incentive values will increase with each consecutive negative sample. Following the initial quit week, the schedule of monitoring will be reduced and incentives will be contingent on submitting a negative saliva cotinine test.
Best PracticesBehavioural
Best Practices- The 2008 Clinical Practice Guidelines for smoking cessation recommends that pregnant smokers be provided with the 5As. Research staff will implement the 5As at three assessments that take place during pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| Best Practices | Active comparator | Not described Receives: Behavioral: Best Practices |
| Best Practices + Financial Incentives | Experimental | Not described Receives: Behavioral: Smartphone-based Financial Incentives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Pregnancy Quit Rate
Point prevalence smoking abstinence (defined as a cotinine-negative saliva test AND self-reported no smoking in the past seven days)
Measured: One month after participant's enrollment date
Late Pregnancy Quit Rate
Point prevalence smoking abstinence (defined as a cotinine-negative saliva test AND self-reported no smoking in the past seven days)
Measured: 28 weeks gestation or later
4-week Postpartum Quit Rate
Point prevalence smoking abstinence (defined as a cotinine-negative saliva test AND self-reported no smoking in the past seven days)
Measured: 4 weeks following the date that participants deliver their infant
8-week Postpartum Quit Rate
Point prevalence smoking abstinence (defined as a cotinine-negative saliva test AND self-reported no smoking in the past seven days)
Measured: 8 weeks following the date that participants deliver their infant
12-week Postpartum Quit Rate
Point prevalence smoking abstinence (defined as a cotinine-negative saliva test AND self-reported no smoking in the past seven days)
Measured: 12 weeks following the date that participants deliver their infant
24-week Postpartum Follow-up
Point prevalence smoking abstinence (defined as a cotinine-negative saliva test AND self-reported no smoking in the past seven days)
Measured: 24 weeks following the date that participants deliver their infant
Longest Duration of Abstinence (LDA)
Consecutive days of no smoking using biochemical verification (cotinine-negative saliva at the formal assessments described above) plus self-report (cigarettes per day from enrollment to 24 wks postpartum reported during timeline follow-back conducted over the phone)
Measured: LDA will be measured from participant's date of enrollment in the study to 24-wks postpartum
Mean birth weight
Mean birth weight (in grams) as reported on delivery reports among infants born to mothers enrolled in the study
Measured: Participants sign a medical release for their infant's birth report prior to study enrollment. Fax requests for infant birth reports are submitted upon confirming actual delivery dates/locations with them or within 1 month of expected delivery dates
Gestational age at delivery
Gestational age (in weeks) at delivery as reported on delivery reports among infants born to mothers enrolled in the study
Measured: Participants sign a medical release for their infant's birth report prior to study enrollment. Fax requests for infant birth reports are submitted upon confirming actual delivery dates/locations with them or within 1 month of expected delivery dates
NICU admissions
Yes/no regarding whether infant was admitted to the NICU, and number of days in the NICU, as reported on delivery reports among infants born to mothers enrolled in the study
Measured: Participants sign a medical release for their infant's birth report prior to study enrollment. Fax requests for infant birth reports are submitted upon confirming actual delivery dates/locations with them or within 1 month of expected delivery dates
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start1 Apr 2019
- Primary completion16 Jun 2021
- Study completion16 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We are proposing a two condition, parallel groups, randomized controlled trial (RCT) of a mobile-phone-based financial incentives intervention targeting economically disadvantaged pregnant cigarette smokers. The experimental group will receive electronic vouchers contingent on the remote submission of breath carbon monoxide (CO) samples indicating smoking abstinence whereas the control group will receive best practices for promoting smoking cessation. The use of a best practices control group reflects a real-world comparison condition in that all women will receive the treatment that practitioners in the community are instructed to provide (i.e., the 5As plus quit-line referral) thereby enhancing the ecological validity of the study, while also minimizing between-subject variability in the extent of participants' exposure to these practices by implementing these treatment components ourselves.
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allison N Kurti, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03922360
- Sponsor's protocol ID
- CHRMS 17-0604
- Status last verified
- May 2026
- First submitted
- 4 Apr 2019
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone-based Financial Incentives
- ClinicalTrials.gov ID
- NCT03922360
- Acronym / sponsor ID
- CHRMS 17-0604
- Conditions
- Tobacco Use Disorder
- Keywords
- Nicotine Dependence, Financial Incentives, Pregnant Women, Smoking Cessation, mHealth, Smartphone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 16 Jun 2021 (actual)
- Study completion
- 16 Jun 2021 (actual)
- First posted
- 19 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cigarette smoking during pregnancy increases risk for catastrophic pregnancy complications, growth retardation, other adverse fetal and infant health problems, and later-in-life chronic conditions among exposed offspring. The most effective intervention for reducing smoking during pregnancy is financial incentives whereby participants earn incentives (e.g., gift cards, cash) contingent on objective evidence of smoking abstinence. However, financial incentives-based interventions are typically delivered in relatively intense protocols requiring frequent clinic visits, which limits the geographical range over which services can be delivered and potentially denies treatment to those residing in remote or otherwise difficult to reach settings.
The present study will examine the feasibility, efficacy, and cost-effectiveness of a smartphone-based financial incentives intervention whereby smoking monitoring and delivery of incentives are completed remotely using a mobile app (to be designed by DynamiCare Health, Inc.). Eligible participants who complete the informed consent process will be randomized to one of two conditions: an incentives condition wherein women will receive financial incentives contingent on the remote submission of breath and saliva specimens indicating abstinence from recent smoking (described below), or a best practices control condition in which women will receive usual care for smoking cessation that is provided at their obstetrical clinics, as well as three brief educational sessions and referral to the Vermont (or other state) pregnancy-specific quit line by our research staff.
For inclusion in the study, women must meet the following criteria: (a) > 18 years of age, (b) report being smokers at the time they learned of the current pregnancy, (c) report smoking in the 7 days prior to completing their phone eligibility screening, (c) < 25 weeks pregnant, (d) speak English, (e) own a smartphone (Android or iOS; 81.8% of pregnant women in wave 1 [2013-2014] of the Population Assessment of Tobacco and Health [PATH] reported owning a smartphone). Exclusion criteria include: (a) current or prior mental or medical condition that may interfere with study participation (assessed via self-report during phone eligibility screening), (b) smoke marijuana more than once each week and not willing to quit (marijuana smoking can inflate breath CO), (c) exposed to unavoidable occupational sources of CO (e.g., car mechanic), and (d) self-report currently being maintained on opioid maintenance therapy (e.g., methadone, buprenorphine).
Participants randomized to the incentives condition will select a quit date (either the first or second Monday following their enrollment), and will submit videos of themselves blowing into a breath CO monitor twice daily during week 1. They will receive incentives for every sample where expired breath CO is < 6 ppm. Beginning in week 2 and extending through week 6, participants will submit videos twice per week (Monday/Thursday) for which they will receive incentives for providing videos of themselves completing saliva cotinine tests indicating smoking abstinence. From week 7 until delivery, participants will submit videos once per week and will continue to receive incentives for saliva cotinine tests indicating no smoking. During the postpartum period, women will submit videos twice weekly for the first 4 weeks and once weekly from weeks 5-12. Women will receiving incentives for negative breath and saliva samples, and the value of incentives will increase with each consecutive sample indicating smoking abstinence. Participants will not receive incentives for missed samples or samples that indicate smoking, and the incentive schedule will be reset at its starting value. However two consecutive negative samples following a missed or positive sample will restore the incentive to its prior value.
Women in both conditions will complete seven formal assessments of their smoking status during their participation along with a treatment acceptability questionnaire and semi-structured interview on barriers and facilitators of treatment engagement.
We conducted a power analysis to estimate the number of participants required to detect treatment effects assuming late-pregnancy abstinence rates of approximately 40% vs. < 10% (incentives vs. best practices, respectively), and 24-week postpartum abstinence rates of approximately 20% vs. < 5%. The proposed sample size of 76 per treatment condition will result in at least 80% power to detect a difference between the two treatment conditions in abstinence rates of 40% vs. 10 % at late-pregnancy or 20% vs. 5% at 24-weeks postpartum assessments using a chi-square test and significance level of 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We are proposing a two condition, parallel groups, randomized controlled trial (RCT) of a mobile-phone-based financial incentives intervention targeting economically disadvantaged pregnant cigarette smokers. The experimental group will receive electronic vouchers contingent on the remote submission of breath carbon monoxide (CO) samples indicating smoking abstinence whereas the control group will receive best practices for promoting smoking cessation. The use of a best practices control group reflects a real-world comparison condition in that all women will receive the treatment that practitioners in the community are instructed to provide (i.e., the 5As plus quit-line referral) thereby enhancing the ecological validity of the study, while also minimizing between-subject variability in the extent of participants' exposure to these practices by implementing these treatment components ourselves.
| Arm | Type | Receives |
|---|---|---|
| Best Practices | Active comparator | Behavioral: Best Practices |
| Best Practices + Financial Incentives | Experimental | Behavioral: Smartphone-based Financial Incentives |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- > 18 years of age
- report being smokers at the time they learned of the current pregnancy
- report smoking in the 7 days prior to completing their preliminary eligibility screening,
- < 25 weeks pregnant
- speak English
Key exclusion criteria (4 listed)
- current or prior mental or medical condition that may interfere with study participation (assessed via self-report during formal intake assessment completed online or by phone using a medical and psychosocial history questionnaire)
- smoke marijuana more than once each week and not willing to quit (marijuana smoking can inflate breath CO)
- exposed to unavoidable occupational sources of CO (e.g., car mechanic)
- report currently receiving opioid maintenance therapy (e.g., methadone, buprenorphine).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone-based Financial IncentivesAlso: Contingency ManagementBest Practices- The 2008 Clinical Practice Guidelines for smoking cessation recommends that pregnant smokers be provided with the 5As. Research staff will implement the 5As at three assessments that take place during pregnancy. Best Practices + Financial Incentive- Women assigned to this condition will receive the best practices treatment described above plus the remote incentives intervention. Beginning on the quit date and extending for one week, participants will be required to submit twice daily CO samples. All samples < 6 ppm will be considered negative and those > 6 ppm will be considered positive. Participants will earn incentives for breath tests indicating smoking abstinence, and incentive values will increase with each consecutive negative sample. Following the initial quit week, the schedule of monitoring will be reduced and incentives will be contingent on submitting a negative saliva cotinine test. | Behavioural | Best Practices + Financial Incentives |
| Best PracticesBest Practices- The 2008 Clinical Practice Guidelines for smoking cessation recommends that pregnant smokers be provided with the 5As. Research staff will implement the 5As at three assessments that take place during pregnancy. | Behavioural | Best Practices |
Primary outcome
Early Pregnancy Quit Rate
Time frame: One month after participant's enrollment date
Point prevalence smoking abstinence (defined as a cotinine-negative saliva test AND self-reported no smoking in the past seven days)
Late Pregnancy Quit Rate
Time frame: 28 weeks gestation or later
Point prevalence smoking abstinence (defined as a cotinine-negative saliva test AND self-reported no smoking in the past seven days)
4-week Postpartum Quit Rate
Time frame: 4 weeks following the date that participants deliver their infant
Point prevalence smoking abstinence (defined as a cotinine-negative saliva test AND self-reported no smoking in the past seven days)
8-week Postpartum Quit Rate
Time frame: 8 weeks following the date that participants deliver their infant
Point prevalence smoking abstinence (defined as a cotinine-negative saliva test AND self-reported no smoking in the past seven days)
12-week Postpartum Quit Rate
Time frame: 12 weeks following the date that participants deliver their infant
Point prevalence smoking abstinence (defined as a cotinine-negative saliva test AND self-reported no smoking in the past seven days)
24-week Postpartum Follow-up
Time frame: 24 weeks following the date that participants deliver their infant
Point prevalence smoking abstinence (defined as a cotinine-negative saliva test AND self-reported no smoking in the past seven days)
Longest Duration of Abstinence (LDA)
Time frame: LDA will be measured from participant's date of enrollment in the study to 24-wks postpartum
Consecutive days of no smoking using biochemical verification (cotinine-negative saliva at the formal assessments described above) plus self-report (cigarettes per day from enrollment to 24 wks postpartum reported during timeline follow-back conducted over the phone)
Mean birth weight
Time frame: Participants sign a medical release for their infant's birth report prior to study enrollment. Fax requests for infant birth reports are submitted upon confirming actual delivery dates/locations with them or within 1 month of expected delivery dates
Mean birth weight (in grams) as reported on delivery reports among infants born to mothers enrolled in the study
Gestational age at delivery
Time frame: Participants sign a medical release for their infant's birth report prior to study enrollment. Fax requests for infant birth reports are submitted upon confirming actual delivery dates/locations with them or within 1 month of expected delivery dates
Gestational age (in weeks) at delivery as reported on delivery reports among infants born to mothers enrolled in the study
NICU admissions
Time frame: Participants sign a medical release for their infant's birth report prior to study enrollment. Fax requests for infant birth reports are submitted upon confirming actual delivery dates/locations with them or within 1 month of expected delivery dates
Yes/no regarding whether infant was admitted to the NICU, and number of days in the NICU, as reported on delivery reports among infants born to mothers enrolled in the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone-based Financial Incentives and Best Practices in people with Tobacco Use Disorder, run by University of Vermont at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Pregnancy Quit Rate (time frame: One month after participant's enrollment date). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.