Trial record 4 of 6 for:    anatabine

Financial Incentive for Smoking Cessation in Pregnancy (FISCP)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2015 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Collaborator:
National Cancer Institute, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT02606227
First received: November 5, 2015
Last updated: November 19, 2015
Last verified: November 2015
  Purpose

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 Intervention
Pregnancy
Smoking
Behavioral: Financial incentive
Other: No financial incentive

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Financial Incentive for Smoking Cessation in Pregnancy

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

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


Secondary Outcome Measures:
  • Birth weight [ Time Frame: Newborns' weight at birth ] [ Designated as safety issue: Yes ]
  • 7-day point prevalence abstinence [ Time Frame: Last 6 months of pregnancy ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    12 item French Tobacco Craving questionnaire (FTCQ12)

  • Tobacco withdrawal symptoms [ Time Frame: Last 6 months of pregnancy ] [ Designated as safety issue: No ]
    Updated Minnesota Nicotine Withdrawal Scale (NMWS)

  • Urinary anabasine (ng/mL) [ Time Frame: At baseline and at a randomly chosen visit before delivery ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Biological markers of tobacco use (anabasine, anatabine) or nicotine uptake


Estimated Enrollment: 480
Study Start Date: December 2015
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02606227

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

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
National Cancer Institute, France
Investigators
Principal Investigator: BERLIN Ivan Assistance Publique - Hôpitaux de Paris
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02606227     History of Changes
Other Study ID Numbers: P140106 
Study First Received: November 5, 2015
Last Updated: November 19, 2015
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Pregnant smokers
smoking cessation
financial incentives
control group
randomized study

ClinicalTrials.gov processed this record on April 27, 2016