Contingency Management for Smoking Cessation in Pregnant Minority Women

Not Applicable

Withdrawn

• Conditions: Cigarette Smoking
• Interventions: Other: Quit Smoking Now (QSN); Behavioral: Prize-based Contingency Management (CM)

• Registration Number: NCT02195570
• Lead Sponsor: University of Miami

Brief 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. 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-07-16
• Study First Submitted QC: 2014-07-17
• Study First Posted: 2014-07-21
• Study Start: 2015-10
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-06
• Last Update Posted: 2019-05-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
QSN with CM (QSN-CM).	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 with CM (QSN-CM).	Quit Smoking Now (QSN)	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	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.

Primary Outcome Measures

Name	Time	Method
Abstinence rate (%)	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.
Abstinence Duration	(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
QSN attendance	(6 weeks)	* cumulative attendance at QSN sessions (1-6 weeks); * QSN attendance logs

Secondary Outcome Measures

Name	Time	Method
Gestational Age	delivery	* measured in weeks; * documented through medical chart review
Birth Weight	delivery	* birth weight measured in grams; * documented through medical chart review
Neonatal Admissions	delivery	* duration in days; * documented through medical chart review
Smoking reduction	Change (baseline and delivery; baseline and 6 months postpartum)	-change in the number of cigarettes smoked daily by self-report
Infant Respiratory Illnesses	6 months postpartum	* number of episodes; * documented through medical chart review

Trial Locations

Locations (1)

University of Miami Miller School of Medicine; 🇺🇸 Miami, Florida, United States