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Voucher Based Incentives to Treat Pregnant Smokers

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ClinicalTrials.gov Identifier: NCT01801384
Recruitment Status : Unknown
Verified March 2013 by Stephen T. Higgins, University of Vermont.
Recruitment status was:  Active, not recruiting
First Posted : February 28, 2013
Last Update Posted : March 28, 2013
Sponsor:
Information provided by (Responsible Party):
Stephen T. Higgins, University of Vermont

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.

Condition or disease Intervention/treatment Phase
Cigarette Smoking Antepartum and Early Postpartum. Behavioral: Voucher-based incentives Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of the Efficacy of Voucher-Based Incentives to Treat Pregnant Smokers
Study Start Date : April 2006
Actual Primary Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Experimental: Original contingent vouchers schedule
Women will receive an abstinence-contingent voucher-based incentives intervention (Contingency Management) for smoking cessation and relapse prevention.
Behavioral: Voucher-based incentives
Other Name: Contingency Management

Experimental: Revised contingent vouchers schedule
Women receive abstinence-contingent voucher-based incentives (Contingency Management) intervention designed to further increase cessation and relapse prevention rates.
Behavioral: Voucher-based incentives
Other Name: Contingency Management

Sham Comparator: Non-contingent vouchers schedule
This serves as a control condition wherein women earn incentives independent of smoking status.
Behavioral: Voucher-based incentives
Other Name: Contingency Management




Primary Outcome Measures :
  1. Biochemical verification of smoking status. [ Time Frame: 15 months ]

Secondary Outcome Measures :
  1. birth outcomes [ Time Frame: 9 months ]
    Assessing the impact of smoking cessation on birth outcomes.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

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Exclusion Criteria: 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.

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01801384


Locations
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United States, Vermont
Substance Abuse Treatment Center, University of Vermont; UHC
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
University of Vermont
Investigators
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Principal Investigator: Stephen T Higgins, Ph.D. University of Vermont
Publications of Results:
Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Stephen T. Higgins, Professor of Psychiatry and Psychology, University of Vermont
ClinicalTrials.gov Identifier: NCT01801384    
Other Study ID Numbers: R01DA014028 ( U.S. NIH Grant/Contract )
First Posted: February 28, 2013    Key Record Dates
Last Update Posted: March 28, 2013
Last Verified: March 2013
Keywords provided by Stephen T. Higgins, University of Vermont:
pregnancy
cigarette smoking
incentives
smoking cessation
birth outcomes