NCT04132232|CompletedResults
Smoking Reduction In Gravid Substance Use Disorders
SIGS
Smoking Reduction In Gravid Women With Substance Use Disorders (SIGS): A Randomized Controlled Trial
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Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Jefferson County Health Fund
OTHER_GRANT · University of Alabama Ob/Gyn Fund for Excellence in Education
interventional
74
1 country
1
Study Start
February 15, 2021
Actual (reported)Primary Completion
December 1, 2023
Actual (reported)Study Completion
December 1, 2023
Actual (reported)The aim of this study is to encourage smoking cessation in women with substance use disorders by providing knowledge of expired carbon monoxide. We hypothesize that women who are provided knowledge of their expired carbon monoxide and the associated percent fetal carboxyhemoglobin will have a greater success at quitting smoking during pregnancy than women who are not provided this information. A secondary aim of the study is to correlate expired carbon monoxide throughout pregnancy with infant birth weight.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 1, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 12, 2019
Actual (reported)October 18, 2019
Actual (reported)February 15, 2021
Actual (reported)December 1, 2023
Actual (reported)December 1, 2023
Actual (reported)August 5, 2024
Actual (reported)Prevalence of Smoking ≥ 10 Cigarettes/Day in Each Group at Final Measurement by Exhaled Carbon Monoxide Level
Prevalence of smoking ≥ 10 cigarettes/day in each group at final measurement by exhaled carbon monoxide level at last prenatal visit prior to delivery, as measured by exhaled carbon monoxide
Final measurement (last prenatal care visit or at delivery)
1. The patient will exhaled into the Smokerlyzer® device will at each visit 2. Exhaled carbon monoxide and fetal carboxyhemoglobin levels will be disclosed to the patient 3. Risks of adverse perinatal outcomes related to maternal carboxyhemoglobin and fetal carboxyhemoglobin level will be provided.
1. The patient will exhale into the Smokerlyzer® device at each visit. 2. Exhaled carbon monoxide and fetal carboxyhemoglobin level will NOT be disclosed to the patient 3. No risks of adverse perinatal outcomes related to maternal carbon monoxide and fetal carboxyhemoglobin levels will be provided
Will use the Smokerlyzer® device at each visit and be provided information on exhaled carbon monoxide and fetal carboxyhemoglobin. Risks of adverse perinatal outcomes related to maternal carbon monoxide and fetal carboxyhemoglobin level will be provided.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Alabama
Birmingham, Alabama, 35233, United States
Sandberg A, Skold CM, Grunewald J, Eklund A, Wheelock AM. Assessing recent smoking status by measuring exhaled carbon monoxide levels. PLoS One. 2011;6(12):e28864. doi: 10.1371/journal.pone.0028864. Epub 2011 Dec 16.
Bedfont. Smokerlyzer range user manual. http://www.bedfont.com/file.php?f=ZmlsZSMjMTgxMg. Updated 2019. Accessed Sept 16, 2016.
Gomez C, Berlin I, Marquis P, Delcroix M. Expired air carbon monoxide concentration in mothers and their spouses above 5 ppm is associated with decreased fetal growth. Prev Med. 2005 Jan;40(1):10-5. doi: 10.1016/j.ypmed.2004.04.049.
Rachel G Sinkey, MD
University of Alabama at Birmingham
74 participants (actual enrollment reported by the registry).
First Submitted
October 12, 2019
First Posted
October 18, 2019
Study Start
Adapt2Quit - An Adaptive Motivational System for Socio-Economically Disadvantaged Smokers
Contact the study team to confirm eligibility.
Goldstein AO, Gans SP, Ripley-Moffitt C, Kotsen C, Bars M. Use of Expired Air Carbon Monoxide Testing in Clinical Tobacco Treatment Settings. Chest. 2018 Feb;153(2):554-562. doi: 10.1016/j.chest.2017.11.002. Epub 2017 Nov 11.
Riaz M, Lewis S, Coleman T, Aveyard P, West R, Naughton F, Ussher M. Which measures of cigarette dependence are predictors of smoking cessation during pregnancy? Analysis of data from a randomized controlled trial. Addiction. 2016 Sep;111(9):1656-65. doi: 10.1111/add.13395. Epub 2016 May 6.
Jha P, Ramasundarahettige C, Landsman V, Rostron B, Thun M, Anderson RN, McAfee T, Peto R. 21st-century hazards of smoking and benefits of cessation in the United States. N Engl J Med. 2013 Jan 24;368(4):341-50. doi: 10.1056/NEJMsa1211128.
QuickStats: Number of Deaths from 10 Leading Causes,* by Sex - National Vital Statistics System, United States, 2015. MMWR Morb Mortal Wkly Rep. 2017 Apr 21;66(15):413. doi: 10.15585/mmwr.mm6615a8.
Middleton ET, Morice AH. Breath carbon monoxide as an indication of smoking habit. Chest. 2000 Mar;117(3):758-63. doi: 10.1378/chest.117.3.758.
McClure JB. Are biomarkers a useful aid in smoking cessation? A review and analysis of the literature. Behav Med. 2001 Spring;27(1):37-47. doi: 10.1080/08964280109595770.
11. Bedfont. Smokerlyzer range user manual. http://www.bedfont.com/file.php?f=ZmlsZSMjMTgxMg. Updated 2019. Accessed Sept 16, 2019.
Shahab L, West R, McNeill A. A randomized, controlled trial of adding expired carbon monoxide feedback to brief stop smoking advice: evaluation of cognitive and behavioral effects. Health Psychol. 2011 Jan;30(1):49-57. doi: 10.1037/a0021821.
Bize R, Burnand B, Mueller Y, Rege-Walther M, Camain JY, Cornuz J. Biomedical risk assessment as an aid for smoking cessation. Cochrane Database Syst Rev. 2012 Dec 12;12:CD004705. doi: 10.1002/14651858.CD004705.pub4.
Reynolds CME, Egan B, Kennedy RA, O'Malley E, Sheehan SR, Turner MJ. The implications of high carbon monoxide levels in early pregnancy for neonatal outcomes. Eur J Obstet Gynecol Reprod Biol. 2019 Feb;233:6-11. doi: 10.1016/j.ejogrb.2018.11.020. Epub 2018 Nov 30.
Ecker J, Abuhamad A, Hill W, Bailit J, Bateman BT, Berghella V, Blake-Lamb T, Guille C, Landau R, Minkoff H, Prabhu M, Rosenthal E, Terplan M, Wright TE, Yonkers KA. Substance use disorders in pregnancy: clinical, ethical, and research imperatives of the opioid epidemic: a report of a joint workshop of the Society for Maternal-Fetal Medicine, American College of Obstetricians and Gynecologists, and American Society of Addiction Medicine. Am J Obstet Gynecol. 2019 Jul;221(1):B5-B28. doi: 10.1016/j.ajog.2019.03.022. Epub 2019 Mar 27. No abstract available.
February 15, 2021
Actual (reported)Primary Completion
December 1, 2023
Actual (reported)Study Completion
December 1, 2023
Actual (reported)Last Updated
August 5, 2024
Results First Posted
August 5, 2024
Record last verified: 2024-02
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