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Financial Incentive for Smoking Cessation in Pregnancy (FISCP)

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ClinicalTrials.gov Identifier: NCT02606227
Recruitment Status : Unknown
Verified January 2018 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
First Posted : November 17, 2015
Last Update Posted : January 12, 2018
Sponsor:
Collaborator:
National Cancer Institute, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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Brief Summary:

Maternal smoking during pregnancy (MSDP) increases the risk of adverse pregnancy and birth outcomes and may have long-lasting effects in the offspring.Financial incentives may increase smoking abstinence rate in pregnancy and therefore reduce MSDP related negative health effects. This is a randomized open label study comparing financial incentives for smoking abstinence with no financial incentives for smoking abstinence.Research objectives

  1. To test the efficacy of financial incentives on smoking abstinence rate among pregnant smokers;
  2. To explore the heterogeneity of efficacy according to individual characteristics: socioeconomic status, social background, smoking characteristics, personality traits, time and risk preferences to determine profiles of women which could benefit best from this kind of intervention;
  3. To provide a cost-benefit analysis based on the cost of newborn and children disease due to maternal smoking during pregnancy.

Condition or disease Intervention/treatment Phase
Pregnancy Smoking Behavioral: Financial incentive Other: No financial incentive Not Applicable

Detailed Description:

Multicenter, national study. Participants are pregnant smokers of at least 18 years old, smoking at least 5 manufactured or 3 rolled-on-their-own cigarettes per day. They will be randomly assigned according to a 1:1 ratio to receive either a financial incentive (20€/visit) to attend the 5 study visits (control group) or receive this show-up incentive plus an incentive for being abstinent at visit(s) on a progressive manner (treatment group). The incentives will be delivered as vouchers. Two hundred and forty pregnant smokers will be randomized into the control and treatment groups, respectively. The study will be run in several maternity wards across France all of whom routinely treat pregnant smokers.

Expected results

  • Financial incentives rewarding progressive abstinence from smoking will increase abstinence rate more than lack of financial incentives.
  • Forward looking and time consistent women will be more likely to stop smoking.
  • If the clinical efficacy and cost effectiveness are demonstrated, financial incentives can be introduced as a standard intervention in helping pregnant smokers quit.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Financial Incentive for Smoking Cessation in Pregnancy
Study Start Date : April 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental group:financial incentives
Vouchers for show up + Vouchers at increasing amount to reward tobacco abstinence
 Behavioral: Financial incentive
Vouchers
Control group:no financial intervention
Vouchers for show up only, no financial incentive for rewarding tobacco abstinence
 Other: No financial incentive
No financial intervention


Outcome Measures
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Primary Outcome Measures :
  1. Continuous smoking abstinence since target quit date until last visit before delivery. [ Time Frame: Last 6 months of pregnancy ]
    Self-report of no smoking confirmed by expired air carbon monoxyde ≤8 ppm at all visits.


Secondary Outcome Measures :
  1. Birth weight [ Time Frame: Newborns' weight at birth ]
  2. 7-day point prevalence abstinence [ Time Frame: Last 6 months of pregnancy ]
    Self-report of no smoking confirmed by expired air carbon monoxyde ≤8 ppm.

  3. Time to relapse to smoking [ Time Frame: Between quit date and last visit before delivery, a maximum time frame of 6 months. ]
    Time in days between predefined quit date and first cigarette smoked after quit date as ascertained at the presential visits and relapse confirmed by expired air CO higher than 8 ppm and self-report of smoking.

  4. Craving for tobacco [ Time Frame: Last 6 months of pregnancy ]
    12 item French Tobacco Craving questionnaire (FTCQ12)

  5. Tobacco withdrawal symptoms [ Time Frame: Last 6 months of pregnancy ]
    Updated Minnesota Nicotine Withdrawal Scale (NMWS)

  6. Urinary anabasine (ng/mL) [ Time Frame: At baseline and at a randomly chosen visit before delivery ]
    Biological markers of tobacco use (anabasine, anatabine) or nicotine uptake (cotinine)

  7. Urinary anatabine (ng/mL) [ Time Frame: At baseline and at a randomly chosen visit before delivery ]
    Biological markers of tobacco use (anabasine, anatabine) or nicotine uptake

  8. Urinary cotinine (ng/mL) [ Time Frame: At baseline and at a randomly chosen visit before delivery ]
    Biological markers of tobacco use (anabasine, anatabine) or nicotine uptake


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Pregnant women
  2. At least 18 years old
  3. Smoking at least 5 manufactured cigarettes or 3 rolled-on-your-own cigarettes
  4. Of <18 weeks of gestation
  5. Motivated to quit smoking
  6. Affiliated to social security system
  7. And who signed the written informed consent form

Exclusion Criteria:

  1. Psychiatric disorders
  2. Use of other tobacco products (pipe, cigar, oral tobacco) than cigarettes
  3. Use of bupropion or varenicline
  4. Use of electronic cigarettes during the current pregnancy
  5. Women already included in a biomedical research
Contacts and Locations
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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): NCT02606227


Contacts
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Contact: BERLIN Ivan, MD 33(0)142161678 ivan.berlin@aphp.fr

Locations
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France
Groupe Hospitalier Pitié-Salpétrière Recruiting
Paris, France, 75013
Contact: BERLIN Ivan         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
National Cancer Institute, France
Investigators
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Principal Investigator: BERLIN Ivan Assistance Publique - Hôpitaux de Paris
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02606227    
Other Study ID Numbers: P140106
First Posted: November 17, 2015    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Pregnant smokers
smoking cessation
financial incentives
control group
randomized study