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Voucher Based Incentives to Treat Pregnant Smokers

Phase 2 Study of the Efficacy of Voucher-Based Incentives to Treat Pregnant Smokers

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01801384
Enrollment
166
Registered
2013-02-28
Start date
2006-04-30
Completion date
2011-05-31
Last updated
2023-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Efficacy of Financial Incentives

Keywords

pregnancy, cigarette smoking, incentives, smoking cessation, birth outcomes

Brief summary

The major goal of this project is to examine the efficacy of a voucher-based incentive program for promoting smoking cessation (Study 1) and preventing relapse (Study 2) during pregnancy and postpartum. Identifying efficacious interventions to increase cessation rates and decrease relapse among those who are able to quit is important to improving U.S. public health.

Detailed description

Maternal cigarette smoking is the leading preventable cause of poor pregnancy outcomes and pediatric morbidity and mortality in the U.S. Efficacious interventions have been developed for smoking cessation during pregnancy, but cessation rates are low, typically under 20%. Efficacious interventions to prevent postpartum relapse remain to be developed. This application seeks support for a Stage II behavioral therapies development project to continue examining interventions to increase smoking cessation above the low levels noted above and to decrease postpartum relapse. With regard to cessation, we conducted studies during the prior funding period showing that voucher-based incentives delivered contingent on biochemically-verified abstinence promote smoking cessation in approximately 40% of women who were still smoking at their 1st prenatal visit compared to only 9% in a control condition. Comparable studies on decreasing postpartum relapse among women who were smokers upon learning of their pregnancy but quit by their 1st prenatal visit (spontaneous quitters) supported the efficacy of abstinence-contingent vouchers for preventing antepartum but not postpartum relapse. We also completed secondary studies on appropriate cutpoints for biochemically verifying smoking status in pregnant women, characterizing the quantitative relationship between smoking exposure and fetal growth, the time-course of depressive symptoms during pregnancy in smokers and abstainers, and the incidence and severity of nicotine withdrawal. While the treatment effect on smoking cessation during pregnancy noted above is at least two-fold greater than usual outcomes, the majority of women, especially heavier smokers (\> 10 cigs/day), failed to quit. In Study 1 of this application we propose to experimentally examine whether a revised voucher program designed to increase initial abstinence and encourage additional quit attempts among those who initially fail can promote cessation at the end-of-pregnancy assessment in the majority of women treated (\> 60%). Considering that nobody has succeeded in decreasing postpartum relapse among spontaneous quitters, we are not surprised that our first effort was unsuccessful. In Study 2 of this application we propose to experimentally test whether a revised voucher-based incentive program designed to more effectively reinforce sustained abstinence will decrease postpartum relapse. We are also proposing to continue secondary studies on biochemical verification of smoking status, fetal growth, and predictors of postpartum relapse. Overall, the proposed studies have the potential to contribute important new information on effective treatments for one of our nation's most daunting drug abuse problems.

Interventions

BEHAVIORALVoucher-based incentives

Sponsors

University of Vermont
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

Only women will participate in the proposed study, because the overarching aim is to develop efficacious treatments for smoking cessation and relapse prevention during pregnancy and early postpartum. All participants will be currently pregnant and report being smokers at the time of conception. Those in Study 1 will report continuing to smoke upon entering prenatal care. Those in Study 2 will report having already quit smoking upon entering prenatal care. Women must reside in the county in which the clinic is located, plan to reside in this geographical area through 6 months postpartum, be \< 25 weeks gestation, not be living in a group residence, English speaking, and not regularly receiving psychotropics other than antidepressants. \-

Exclusion criteria

Women receiving opioid substitution therapy will be excluded. In Vermont, minorities comprise 4% of the general population. There will be no

Design outcomes

Primary

MeasureTime frame
Biochemical verification of smoking status.15 months

Secondary

MeasureTime frameDescription
birth outcomes9 monthsAssessing the impact of smoking cessation on birth outcomes.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026