Cigarette SmokingNCT02195570
Contingency Management for Smoking Cessation in Pregnant Minority Women
A study testing Quit Smoking Now (QSN) and Prize-based Contingency Management (CM) in people with Cigarette Smoking, run by University of Miami at 1 site in United States.
Trial summary
The long-term goal of this research is to reduce tobacco-related disparities in maternal and infant health outcomes by improving smoking cessation and relapse prevention interventions for minority pregnant and postpartum women, who have been significantly underrepresented in smoking cessation research. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cigarette Smoking
- What is being tested?
- Quit Smoking Now (QSN) and Prize-based Contingency Management (CM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Aug 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- self-identified daily smoker (at least 1 cigarette/day)
- <28 weeks gestation
- 18 years or older
- resident of Miami-Dade County, Florida
- able to read and speak in English or Spanish
- plans to continue prenatal care with Jackson Health System
- plans to remain in the Miami-Dade County metropolitan area for at least 6 months following delivery.
Who cannot join
- participation in another smoking cessation intervention within the past year
- use of nicotine replacement therapy (NRT) anytime during pregnancy
- inability to give informed consent
- incarceration
- reported regular use of alcohol (>3 times/week) or marijuana (>weekly); any cocaine or opiates in past year; or a positive toxicology for these drugs.
- Study withdrawal will occur in the case of pregnancy termination, fetal demise or by participant request.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Miller School of Medicine
Miami, Florida, 33138
About this study
The long-term goal of this research is to reduce tobacco-related disparities in maternal and infant health outcomes by improving smoking cessation and relapse prevention interventions for minority pregnant and postpartum women, who have been significantly underrepresented in smoking cessation research. This study will examine the feasibility and efficacy of a prize-based contingency management approach for increasing smoking cessation and preventing relapse among socioeconomically disadvantaged minority pregnant smokers. First, the intervention will be pretested with 10 pregnant low-income minority smokers and then refined based on acceptability survey and focus group data. Next, a pilot study will be conducted. 60 highly disadvantaged minority women, recruited from the outpatient obstetric clinics at a large teaching hospital, who report daily smoking and who meet other eligibility criteria will be enrolled and randomized to one of two study conditions: 1) Standard Psychoeducational Intervention (6-week, individually-administered, pregnancy-specific Quit Smoking Now curriculum, as currently implemented in the clinic; QSN Only); 2) Standard Psychoeducational Intervention plus Contingency Management (provision of incentives contingent on biochemically-verified abstinence; QSN-CM). Abstinence monitoring via expired carbon monoxide and salivary cotinine levels will occur in both groups beginning on the first quit day and continuing through 3-months postpartum. Only participants in the QSN-CM group will be reinforced for biochemically-verified abstinence with chances to win prizes ranging in value from approximately $1 to $100 ('fishbowl' or 'prize bowl' method). Study outcomes will be assessed through follow-up research exams (delivery and 6-months postpartum) and hospital chart reviews. The primary hypothesis is that that women randomized to the QSN-CM condition will have higher rates of abstinence during pregnancy and postpartum compared to women receiving standard of care alone. Results should advance scientific knowledge regarding effective methods for promoting and maintaining smoking abstinence among pregnant disadvantaged women and provide preliminary feasibility and efficacy data needed to support a larger randomized controlled trial.
- Conditions
- Cigarette Smoking
- Being tested
- Quit Smoking Now (QSN), Prize-based Contingency Management (CM)
- Keywords
- contingency management, smoking cessation, prenatal tobacco exposure, maternal smoking
- Medical subject headings
- Cigarette Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quit Smoking Now (QSN)Other
The Quit Smoking Now (QSN) program, offered by the Florida Area Health Education Center, was developed based on principles of the Centers for Disease Control and Prevention's "Best Practices for Comprehensive Tobacco Control", and the U.S. Department of Health and Human Services' "Treating Tobacco Use and Dependence Clinical Guidelines" with an emphasis on reaching medically-underserved populations. The QSN curriculum will be delivered in 6 one-hour sessions . Pregnancy-specific session goals and content cover the effects of smoking on the developing fetus, secondhand smoke exposure, the importance of social support, and postpartum relapse.
Prize-based Contingency Management (CM)Behavioural
Women will earn chances to win prizes for biochemically verified abstinence from tobacco.
| Study group | Role | What they receive |
|---|---|---|
| QSN with CM (QSN-CM). | Experimental | Women will receive standard of care Quit Smoking Now tobacco education and support plus prize-based contingency management. Their smoking status will be monitored from quit date through 3 months postpartum via carbon monoxide and salivary cotinine levels. Women will earn chances to win prizes each time they test negative for smoking according to biochemical measures. Receives: Other: Quit Smoking Now (QSN); Behavioral: Prize-based Contingency Management (CM) |
| QSN Only | Active comparator | Women receive the standard of care Quit Smoking Now tobacco education and support only. Smoking status will be monitored from quit date through 3 months postpartum via carbon monoxide and salivary cotinine levels. Incentives are given for providing breath and salivary samples but are not contingent on smoking status. Receives: Other: Quit Smoking Now (QSN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abstinence Duration
-duration in days
--measured by self-report, carbon monoxide, salivary and urine cotinine levels
Measured: (from quit date through 6 months postpartum; assessed up to 52 weeks)
Abstinence rate (%)
- 7-day point prevalence abstinence at delivery and 6 months postpartum defined by no smoking in the 7 days prior to assessment.
- measured by self-report, carbon monoxide and salivary cotinine levels.
Measured: delivery and 6 months postpartum
QSN attendance
- cumulative attendance at QSN sessions (1-6 weeks)
- QSN attendance logs
Measured: (6 weeks)
Secondary outcomes (5)
Smoking reduction
-change in the number of cigarettes smoked daily by self-report
Measured: Change (baseline and delivery; baseline and 6 months postpartum)
Gestational Age
- measured in weeks
- documented through medical chart review
Measured: delivery
Infant Respiratory Illnesses
- number of episodes
- documented through medical chart review
Measured: 6 months postpartum
Birth Weight
- birth weight measured in grams
- documented through medical chart review
Measured: delivery
Neonatal Admissions
- duration in days
- documented through medical chart review
Measured: delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2014 (estimated)
- Study startOct 2015
- Primary completionAug 2018
- Study completionAug 2018
Why it stopped: Unable to identify and recruit eligible participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette SmokingStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Veronica Accornero, University of Miami
- Investigators
- Veronica H Accornero, Ph.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02195570
- Sponsor's protocol ID
- 20130654
- Other IDs
- R34DA031973
- Status last verified
- May 2019
- First submitted
- 16 Jul 2014
- Last updated
- 9 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contingency Management for Smoking Cessation in Pregnant Minority Women
- ClinicalTrials.gov ID
- NCT02195570
- Acronym / sponsor ID
- 20130654
- Conditions
- Cigarette Smoking
- Keywords
- contingency management, smoking cessation, prenatal tobacco exposure, maternal smoking
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to identify and recruit eligible participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Oct 2015
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 21 Jul 2014 (estimated)
- 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.
The long-term goal of this research is to reduce tobacco-related disparities in maternal and infant health outcomes by improving smoking cessation and relapse prevention interventions for minority pregnant and postpartum women, who have been significantly underrepresented in smoking cessation research. This study will examine the feasibility and efficacy of a prize-based contingency management approach for increasing smoking cessation and preventing relapse among socioeconomically disadvantaged minority pregnant smokers. First, the intervention will be pretested with 10 pregnant low-income minority smokers and then refined based on acceptability survey and focus group data. Next, a pilot study will be conducted. 60 highly disadvantaged minority women, recruited from the outpatient obstetric clinics at a large teaching hospital, who report daily smoking and who meet other eligibility criteria will be enrolled and randomized to one of two study conditions: 1) Standard Psychoeducational Intervention (6-week, individually-administered, pregnancy-specific Quit Smoking Now curriculum, as currently implemented in the clinic; QSN Only); 2) Standard Psychoeducational Intervention plus Contingency Management (provision of incentives contingent on biochemically-verified abstinence; QSN-CM). Abstinence monitoring via expired carbon monoxide and salivary cotinine levels will occur in both groups beginning on the first quit day and continuing through 3-months postpartum. Only participants in the QSN-CM group will be reinforced for biochemically-verified abstinence with chances to win prizes ranging in value from approximately $1 to $100 ('fishbowl' or 'prize bowl' method). Study outcomes will be assessed through follow-up research exams (delivery and 6-months postpartum) and hospital chart reviews. The primary hypothesis is that that women randomized to the QSN-CM condition will have higher rates of abstinence during pregnancy and postpartum compared to women receiving standard of care alone. Results should advance scientific knowledge regarding effective methods for promoting and maintaining smoking abstinence among pregnant disadvantaged women and provide preliminary feasibility and efficacy data needed to support a larger randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QSN with CM (QSN-CM). | Experimental | Other: Quit Smoking Now (QSN), Behavioral: Prize-based Contingency Management (CM)Women will receive standard of care Quit Smoking Now tobacco education and support plus prize-based contingency management. Their smoking status will be monitored from quit date through 3 months postpartum via carbon monoxide and salivary cotinine levels. Women will earn chances to win prizes each time they test negative for smoking according to biochemical measures. |
| QSN Only | Active comparator | Other: Quit Smoking Now (QSN)Women receive the standard of care Quit Smoking Now tobacco education and support only. Smoking status will be monitored from quit date through 3 months postpartum via carbon monoxide and salivary cotinine levels. Incentives are given for providing breath and salivary samples but are not contingent on smoking status. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- self-identified daily smoker (at least 1 cigarette/day)
- <28 weeks gestation
- 18 years or older
- resident of Miami-Dade County, Florida
- able to read and speak in English or Spanish
Key exclusion criteria (6 listed)
- participation in another smoking cessation intervention within the past year
- use of nicotine replacement therapy (NRT) anytime during pregnancy
- inability to give informed consent
- incarceration
- reported regular use of alcohol (>3 times/week) or marijuana (>weekly); any cocaine or opiates in past year; or a positive toxicology for these drugs.
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 |
|---|---|---|
| Quit Smoking Now (QSN)The Quit Smoking Now (QSN) program, offered by the Florida Area Health Education Center, was developed based on principles of the Centers for Disease Control and Prevention's "Best Practices for Comprehensive Tobacco Control", and the U.S. Department of Health and Human Services' "Treating Tobacco Use and Dependence Clinical Guidelines" with an emphasis on reaching medically-underserved populations. The QSN curriculum will be delivered in 6 one-hour sessions . Pregnancy-specific session goals and content cover the effects of smoking on the developing fetus, secondhand smoke exposure, the importance of social support, and postpartum relapse. | Other | QSN Only, QSN with CM (QSN-CM). |
| Prize-based Contingency Management (CM)Women will earn chances to win prizes for biochemically verified abstinence from tobacco. | Behavioural | QSN with CM (QSN-CM). |
Primary outcome
Abstinence Duration
Time frame: (from quit date through 6 months postpartum; assessed up to 52 weeks)
-duration in days --measured by self-report, carbon monoxide, salivary and urine cotinine levels
Abstinence rate (%)
Time frame: delivery and 6 months postpartum
* 7-day point prevalence abstinence at delivery and 6 months postpartum defined by no smoking in the 7 days prior to assessment. * measured by self-report, carbon monoxide and salivary cotinine levels.
QSN attendance
Time frame: (6 weeks)
* cumulative attendance at QSN sessions (1-6 weeks) * QSN attendance logs
5 secondary outcomes
Smoking reduction
Time frame: Change (baseline and delivery; baseline and 6 months postpartum)
Gestational Age
Time frame: delivery
Infant Respiratory Illnesses
Time frame: 6 months postpartum
Birth Weight
Time frame: delivery
Neonatal Admissions
Time frame: delivery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2019.
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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.
Veronica H Accornero, Ph.D. principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quit Smoking Now (QSN) and Prize-based Contingency Management (CM) in people with Cigarette Smoking, run by University of Miami 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 7 inclusion and 6 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: withdrawn, as of the sponsor's last update on 9 May 2019. 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 was withdrawn before enrolling participants, so there are no results.
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?
Abstinence Duration (time frame: (from quit date through 6 months postpartum; assessed up to 52 weeks)). The study lists 3 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 9 May 2019.