Financial Incentive for Smoking Cessation in Pregnancy

Pregnancy Clinical Trial

— FISCP  

Official title:

Financial Incentive for Smoking Cessation in Pregnancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02606227
• Other study ID #: P140106
• Status: Recruiting
• Phase: N/A
• First received: November 5, 2015
• Last updated: January 11, 2018
• Start date: April 2016
• Est. completion date: December 2019

Study information

• Verified date: January 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: BERLIN Ivan, MD
• Phone: 33(0)142161678
• Email: ivan.berlin[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy
• Smoking

Intervention

Behavioral:
• Financial incentive
Vouchers

Other:
• No financial incentive
No financial intervention

Locations

Country	Name	City	State
France	Groupe Hospitalier Pitié-Salpétrière	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	National Cancer Institute, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Continuous smoking abstinence since target quit date until last visit before delivery.	Self-report of no smoking confirmed by expired air carbon monoxyde =8 ppm at all visits.	Last 6 months of pregnancy
Secondary	Birth weight		Newborns' weight at birth
Secondary	7-day point prevalence abstinence	Self-report of no smoking confirmed by expired air carbon monoxyde =8 ppm.	Last 6 months of pregnancy
Secondary	Time to relapse to smoking	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.	Between quit date and last visit before delivery, a maximum time frame of 6 months.
Secondary	Craving for tobacco	12 item French Tobacco Craving questionnaire (FTCQ12)	Last 6 months of pregnancy
Secondary	Tobacco withdrawal symptoms	Updated Minnesota Nicotine Withdrawal Scale (NMWS)	Last 6 months of pregnancy
Secondary	Urinary anabasine (ng/mL)	Biological markers of tobacco use (anabasine, anatabine) or nicotine uptake (cotinine)	At baseline and at a randomly chosen visit before delivery
Secondary	Urinary anatabine (ng/mL)	Biological markers of tobacco use (anabasine, anatabine) or nicotine uptake	At baseline and at a randomly chosen visit before delivery
Secondary	Urinary cotinine (ng/mL)	Biological markers of tobacco use (anabasine, anatabine) or nicotine uptake	At baseline and at a randomly chosen visit before delivery