Financial Incentive for Smoking Cessation in Pregnancy (FISCP)

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

Tracking Information

• First Submitted Date: November 5, 2015
• First Posted Date: November 17, 2015
• Last Update Posted Date: January 12, 2018
• Study Start Date: April 2016
• Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 16, 2015)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 19, 2015)

• Birth weight [ Time Frame: Newborns' weight at birth ]
• 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.
• 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.
• Craving for tobacco [ Time Frame: Last 6 months of pregnancy ]
  12 item French Tobacco Craving questionnaire (FTCQ12)
• Tobacco withdrawal symptoms [ Time Frame: Last 6 months of pregnancy ]
  Updated Minnesota Nicotine Withdrawal Scale (NMWS)
• 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)
• 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
• 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

Original Secondary Outcome Measures (submitted: November 16, 2015)

• Birth weight [ Time Frame: Newborns' weight at birth ]
• 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.
• Time to relapse [ Time Frame: Between quit date and last visit before delivery. ]
  Time in days between predefined quit date and first cigarette smoked after quit date.
• Craving for tobacco [ Time Frame: Last 6 months of pregnancy ]
  12 item French Tobacco Craving questionnaire (FTCQ12)
• Tobacco withdrawal symptoms [ Time Frame: Last 6 months of pregnancy ]
  Updated Minnesota Nicotine Withdrawal Scale (NMWS)
• 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)
• 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
• 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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Financial Incentive for Smoking Cessation in Pregnancy
• Official Title: Financial Incentive for Smoking Cessation in Pregnancy

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.

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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Pregnancy
• Smoking

Intervention

• Behavioral: Financial incentive
  Vouchers
• Other: No financial incentive
  No financial intervention

Study Arms

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

Publications *

• Berlin I, Berlin N, Malecot M, Breton M, Jusot F, Goldzahl L. Financial incentives for smoking cessation in pregnancy: multicentre randomised controlled trial. BMJ. 2021 Dec 1;375:e065217. doi: 10.1136/bmj-2021-065217. Erratum In: BMJ. 2021 Dec 3;375:n3012. BMJ. 2022 Feb 22;376:o448.
• Berlin N, Goldzahl L, Jusot F, Berlin I. Protocol for study of financial incentives for smoking cessation in pregnancy (FISCP): randomised, multicentre study. BMJ Open. 2016 Jul 26;6(7):e011669. doi: 10.1136/bmjopen-2016-011669.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: November 16, 2015): 480
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2019
• Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT02606227
• Other Study ID Numbers: P140106
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Assistance Publique - Hôpitaux de Paris
• Original Responsible Party: Same as current
• Current Study Sponsor: Assistance Publique - Hôpitaux de Paris
• Original Study Sponsor: Same as current
• Collaborators: National Cancer Institute, France

Investigators

• Principal Investigator: BERLIN Ivan; Assistance Publique - Hôpitaux de Paris

• PRS Account: Assistance Publique - Hôpitaux de Paris
• Verification Date: January 2018