Contingency Management for Smoking Cessation in Pregnant Minority Women

Cigarette Smoking Clinical Trial

Official title:

Contingency Management for Smoking Cessation in Pregnant Minority Women

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02195570
• Other study ID #: 20130654
• Secondary ID: R34DA031973
• Status: Withdrawn
• Phase: N/A
• Start date: October 2015
• Est. completion date: August 2018

Study information

• Verified date: May 2019
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

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.

Related Conditions & MeSH terms

• Cigarette Smoking

Intervention

Other:
• 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.

Behavioral:
• Prize-based Contingency Management (CM)
Women will earn chances to win prizes for biochemically verified abstinence from tobacco.

Locations

Country	Name	City	State
United States	University of Miami Miller School of Medicine	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abstinence Duration	-duration in days; --measured by self-report, carbon monoxide, salivary and urine cotinine levels	(from quit date through 6 months postpartum; assessed up to 52 weeks)
Primary	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.	delivery and 6 months postpartum
Primary	QSN attendance	cumulative attendance at QSN sessions (1-6 weeks); QSN attendance logs	(6 weeks)
Secondary	Smoking reduction	-change in the number of cigarettes smoked daily by self-report	Change (baseline and delivery; baseline and 6 months postpartum)
Secondary	Gestational Age	measured in weeks; documented through medical chart review	delivery
Secondary	Infant Respiratory Illnesses	number of episodes; documented through medical chart review	6 months postpartum
Secondary	Birth Weight	birth weight measured in grams; documented through medical chart review	delivery
Secondary	Neonatal Admissions	duration in days; documented through medical chart review	delivery