Smoking During Pregnancy and PostpartumNCT07840118
Smartphone-based Incentives Intervention to Increase Smoking Cessation During Pregnancy
A study testing Best Practices and Financial Incentives in people with Smoking During Pregnancy and Postpartum and Perinatal Cigarette Smoking, run by University of Vermont at 1 site in United States.
Trial summary
Cigarette smoking is the leading preventable cause of poor pregnancy outcomes in the U.S. and a problem for which more effective and easy-to-access treatments are much needed. This study examines whether outcomes achieved with recommended clinical practices (referral to state tobacco Quitline with follow-up and… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Smoking During Pregnancy and Postpartum, Perinatal Cigarette Smoking
- What is being tested?
- Best Practices and Financial Incentives
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18 yrs of age
- Reports current pregnancy of </= 25 weeks gestational age
- Consents to allow us to confirm pregnancy with healthcare provider
- Reports current smoking when learned of current pregnancy
- Reports smoking in the 7 days prior to screening
- Reports of smoking in past 7 days is confirmed by a salivary cotinine test
- Owns a digital phone or tablet
- Sufficiently fluent in English to complete study tasks
Who cannot join
- Reports current or prior mental or medical condition that may interfere with study participation
- Reports current opioid agonist treatment for opioid use disorder
- Current use of prescribed opioid, antipsychotic, or stimulant medications
- Live with someone who is enrolled in the study
- Reside in a group home
- Currently participating in another study that provides financial incentives
- Legal problems that may result in incarceration within the next year
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Examining a Digital Perinatal Smoking-Cessation Intervention
Cigarette smoking is the leading preventable cause of poor pregnancy outcomes in the U.S. and a problem for which more effective and easy-to-access treatments are much needed. This study examines whether outcomes achieved with recommended clinical practices (referral to state tobacco Quitline with follow-up and further referrals for those continuing to smoke) can be improved by also offering financial incentives delivered through a smartphone for maternal smoking abstinence.
Read the detailed description
Pregnant women residing in the U.S. who currently smoke cigarettes and are interested in quitting will be recruited nationally and randomly assigned to what is considered clinical best practices (BP) (referral to state tobacco Quitline with follow-up and further referrals for those continuing to smoke) or best practices in combination with financial incentives (BP+FI). Women assigned to the BP+FI treatment will have opportunities to earn financial incentives by abstaining from smoking during pregnancy and for 3 months after delivering their baby (total possible incentives is $750.00). Women will demonstrate that they have abstained by taking brief salivary cotinine tests using a smartphone or equivalent device. Incentives for abstaining are electronically added to a study-provided debit card. Participation and all results are strictly confidential. Participants in both treatment conditions will be financially compensated for study participation with potential earnings of $525.00. Total potential earnings for those assigned to BP is $525.00 and for those assigned to BP+FI it is $1,275 ($525 for study participation and $750 in incentives for quitting smoking).
- Being tested
- Best Practices, Financial Incentives
- Keywords
- cigarettes, smoking, smoking cessation, pregnancy, postpartum, women, financial incentives
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticesBehavioural
Participants receive the 5As including a staff referral to the state tobacco quitline.
Financial IncentivesBehavioural
Participants receive financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum.
| Study group | Role | What they receive |
|---|---|---|
| Best Practices | Experimental | Best Practices (BP) entails the 5As including referral to the state tobacco Quitline and further referral for those continuing to smoke. Receives: Behavioral: Best Practices |
| Best Practices plus Financial Incentives | Experimental | Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum. Receives: Behavioral: Best Practices; Behavioral: Financial Incentives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antepartum smoking abstinence
The primary outcome is whether women randomly assigned to the two treatment groups differ in the percentage who abstain from smoking across an early (< 25 weeks gestation) and late (> 25 weeks gestation) antepartum assessments defined by the percentage of participants assigned to each condition who report no smoking in the past 7 days and submit of a salivary cotinine sample that tests negative for recent smoking.
Measured: Antepartum period is from study entry through infant delivery which is typically about 24 weeks duration.
Secondary outcomes (1)
Postpartum smoking abstinence
Smoking abstinence at 2, 6, and 12 weeks postpartum defined as the percent of participants randomly assigned to each of the two treatment conditions who report no smoking in the past 7 days and submit of a salivary cotinine test sample that is negative for recent smoking.
Measured: 2-weeks, 6-weeks, 12-weeks following delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking During Pregnancy and PostpartumStudies 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
- The design is a two parallel groups randomized clinical trial to assess if combining financial incentives with Best Practices improves outcomes above treatment with Best Practices alone.
- Masking
- None (open label)
- Enrolment
- 137 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- DynamiCare Health, National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Stephen T. Higgins, PhD, University of Vermont
- Investigators
- Stephen T Higgins, PhD, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840118
- Sponsor's protocol ID
- STUDY00004146
- Other IDs
- UG3DA065232
- Status last verified
- Sep 2026
- First submitted
- 27 Aug 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Investigators are willing to share data once the study is completed and results are published in a peer-reviewed journal. Sharing is conditional on those requesting having a scientific rationale for their request.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining a Digital Perinatal Smoking-Cessation Intervention
- ClinicalTrials.gov ID
- NCT07840118
- Acronym / sponsor ID
- STUDY00004146
- Keywords
- cigarettes, smoking, smoking cessation, pregnancy, postpartum, women, financial incentives
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 137 participants (estimated)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- DynamiCare Health, National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2026 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 24 Sep 2026 (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 is the leading preventable cause of poor pregnancy outcomes in the U.S. and a problem for which more effective and easy-to-access treatments are much needed. This study examines whether outcomes achieved with recommended clinical practices (referral to state tobacco Quitline with follow-up and further referrals for those continuing to smoke) can be improved by also offering financial incentives delivered through a smartphone for maternal smoking abstinence.
Detailed description
Pregnant women residing in the U.S. who currently smoke cigarettes and are interested in quitting will be recruited nationally and randomly assigned to what is considered clinical best practices (BP) (referral to state tobacco Quitline with follow-up and further referrals for those continuing to smoke) or best practices in combination with financial incentives (BP+FI). Women assigned to the BP+FI treatment will have opportunities to earn financial incentives by abstaining from smoking during pregnancy and for 3 months after delivering their baby (total possible incentives is $750.00). Women will demonstrate that they have abstained by taking brief salivary cotinine tests using a smartphone or equivalent device. Incentives for abstaining are electronically added to a study-provided debit card. Participation and all results are strictly confidential. Participants in both treatment conditions will be financially compensated for study participation with potential earnings of $525.00. Total potential earnings for those assigned to BP is $525.00 and for those assigned to BP+FI it is $1,275 ($525 for study participation and $750 in incentives for quitting smoking).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The design is a two parallel groups randomized clinical trial to assess if combining financial incentives with Best Practices improves outcomes above treatment with Best Practices alone.
| Arm | Type | Receives |
|---|---|---|
| Best Practices | Experimental | Behavioral: Best PracticesBest Practices (BP) entails the 5As including referral to the state tobacco Quitline and further referral for those continuing to smoke. |
| Best Practices plus Financial Incentives | Experimental | Behavioral: Best Practices, Behavioral: Financial IncentivesBest practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 18 yrs of age
- Reports current pregnancy of </= 25 weeks gestational age
- Consents to allow us to confirm pregnancy with healthcare provider
- Reports current smoking when learned of current pregnancy
- Reports smoking in the 7 days prior to screening
Key exclusion criteria (7 listed)
- Reports current or prior mental or medical condition that may interfere with study participation
- Reports current opioid agonist treatment for opioid use disorder
- Current use of prescribed opioid, antipsychotic, or stimulant medications
- Live with someone who is enrolled in the study
- Reside in a group home
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 |
|---|---|---|
| Best PracticesParticipants receive the 5As including a staff referral to the state tobacco quitline. | Behavioural | Best Practices, Best Practices plus Financial Incentives |
| Financial IncentivesParticipants receive financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum. | Behavioural | Best Practices plus Financial Incentives |
Primary outcome
Antepartum smoking abstinence
Time frame: Antepartum period is from study entry through infant delivery which is typically about 24 weeks duration.
The primary outcome is whether women randomly assigned to the two treatment groups differ in the percentage who abstain from smoking across an early (< 25 weeks gestation) and late (> 25 weeks gestation) antepartum assessments defined by the percentage of participants assigned to each condition who report no smoking in the past 7 days and submit of a salivary cotinine sample that tests negative for recent smoking.
1 secondary outcome
Postpartum smoking abstinence
Time frame: 2-weeks, 6-weeks, 12-weeks following delivery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: Yes. Investigators are willing to share data once the study is completed and results are published in a peer-reviewed journal. Sharing is conditional on those requesting having a scientific rationale for their request.
Related trials for Smoking During Pregnancy and Postpartum
Recruiting
Feasibility and Acceptability Trial to Reduce Tobacco and Cannabis Use During Pregnancy and Postpartum
Perinatal, Cannabis Use
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.
Stephen T Higgins, PhD principal investigator
University of Vermont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practices and Financial Incentives in people with Smoking During Pregnancy and Postpartum and Perinatal Cigarette Smoking, 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 8 inclusion and 7 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: opening soon, as of the sponsor's last update on 24 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephen T Higgins, PhD (802-656-9615, stephen.higgins@uvm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antepartum smoking abstinence (time frame: Antepartum period is from study entry through infant delivery which is typically about 24 weeks duration.). 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 24 Sep 2026.