Phase 2 Study of the Efficacy of Voucher-Based Incentives to Treat Pregnant Smokers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 2
- 主要终点
- Biochemical verification of smoking status.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Women receiving opioid substitution therapy will be excluded. In Vermont, minorities comprise 4% of the general population. There will be no exclusion criteria concerning race or ethnicity. In our studies during the prior funding period, approximately 5% of participants were minorities. We anticipate a similar sample in the proposed studies. We shall do all that we can to assure that minorities are included in the research.
结局指标
主要结局
Biochemical verification of smoking status.
时间窗: 15 months
次要结局
- birth outcomes(9 months)
研究者
Stephen T. Higgins, PhD
Professor of Psychiatry and Psychology
University of Vermont
