Clinical trial NCT02195570: Contingency Management for Smoking Cessation in Pregnant Minority Women
Official title: Contingency Management for Smoking Cessation in Pregnant Minority Women
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cigarette Smoking
Keywords: contingency management
smoking cessation
prenatal tobacco exposure
maternal smoking
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2014-07-21
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Abstinence Duration
timeFrame: (from quit date through 6 months postpartum; assessed up to 52 weeks)
measure: Abstinence rate (%)
timeFrame: delivery and 6 months postpartum
measure: QSN attendance
timeFrame: (6 weeks)
Secondary outcomes:
measure: Smoking reduction
timeFrame: Change (baseline and delivery; baseline and 6 months postpartum)
measure: Gestational Age
timeFrame: delivery
measure: Infant Respiratory Illnesses
timeFrame: 6 months postpartum
measure: Birth Weight
timeFrame: delivery
measure: Neonatal Admissions
timeFrame: delivery
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
Study officials:
affiliation: University of Miami
name: Veronica H Accornero, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: