Smoking Reduction In Gravid Substance Use Disorders

Tobacco Use Disorder Clinical Trial

— SIGS  

Official title:

Smoking Reduction In Gravid Women With Substance Use Disorders (SIGS): A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04132232
• Other study ID #: SIGS
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: December 2022
• Source: University of Alabama at Birmingham
• Contact: Lisa Dimperio
• Phone: 205-934-3276
• Email: ldimperio[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This is a randomized controlled trial. Pregnant smokers who are substances users who meet inclusion criteria will be offered participation in the study at their first obstetrical appointment. Patients who consent to participate will be randomized.

At the enrollment/randomization visit, women will be randomized to either the intervention (knowledge of and interpretation carbon monoxide levels and associated percent fetal carboxyhemoglobin) or control group (no information on carbon monoxide and associated percent fetal carboxyhemoglobin). Allocation will be computer generated. This will be done after the patient meets all inclusion criteria. If randomization to the intervention arm, the patient will be notified of carbon monoxide and associated fetal carboxyhemoglobin levels at each obstetrical visit and counseled on how it affects maternal and fetal health.

If randomized to the control arm, the patient will have expired carbon monoxide and associated fetal carboxyhemoglobin levels measured at each obstetrical visit but blinded to these results. These patients will not be notified of the levels, nor counseled on what levels mean for maternal or fetal health.

See below for intervention and control protocols.

Maternal demographic (age, race, socioeconomic status), medical history (other medical problems, medications, height, weight) and obstetric history (parity, gestational age) data will be abstracted from the patient's chart and supplemented with a patient questionnaire at the enrollment/randomization visit. The primary outcome is the expired maternal carbon monoxide level at the last obstetric visit or at delivery. This will be determined by the Smokerlyzer device used to measure this. Secondary aims of the study will be to evaluate how maternal carbon monoxide levels correlate with fetal growth, cigarette use per day, patient satisfaction and neonatal birth weight.

All patients will have the following performed at the enrollment/randomization visit and subsequent prenatal visits:

a. The order of events for all patients will be as follows: i. Blood pressure evaluation ii. Weight iii. Fundal height iv. Patient will be asked the number of cigarettes used per day v. Patient will exhale into Smokerlyzer device to obtain expired carbon monoxide and associated percent fetal carboxyhemoglobin vi. Patients will be provided smoking cessation resources and counseling on smoking cessation in pregnancy

Intervention Protocol

1. Intervention group will undergo Smokerlyzer ® exhaled carbon monoxide measurements at enrollment, each prenatal visit, and at their last (>36 week) prenatal visit or at delivery if not captured in clinic.

2. Women will be informed of their exhaled carbon monoxide measurement at each visit as well as the correlation to fetal carboxyhemoglobin.

3. At each visit, the intervention group will receive counseling on fetal impact of smoking based on fetal carboxyhemoglobin level and institutional and state information on smoking cessation will be provided.

4. The patient will then proceed to the remainder of the obstetrical visit.

Control Protocol

1. Women in the control group will undergo Smokerlyzer ® exhaled carbon monoxide measurements at enrollment, each prenatal visit and at their final (>36 week) prenatal visit or at delivery if not captured in clinic.

2. Both levels (maternal carbon monoxide and fetal carboxyhemoglobin) will be recorded by the co-investigatory, but NOT disclosed to the patient

3. At each visit, control group will be provided institutional and state information on smoking cessation if they report continued smoking.

4. The patient will then proceed to remainder of the obstetrical visit.

For both groups:

At the time of delivery, maternal and neonatal outcome data will be recorded from the chart, including gestational age at delivery, mode of delivery, indications for delivery, birth weight, Apgar score, cord blood gas, length of stay, and neonatal complications, if any. A survey will be completed for both intervention and standard care groups after delivery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 45 Years

Eligibility

Inclusion Criteria:

i. Age 16-45

ii. Singleton gestation

iii. Gestational age at enrollment <24 weeks

iv. Substance use disorder defined as modified National Institute on Drug Abuse ASSIST =4

v. Cigarette smoker using =10 cigarettes/day interested in quitting

Exclusion criteria:

i. Known or suspected fetal growth restriction at enrollment

ii. Known fetal anomaly, aneuploidy, or demise

iii. Not interested in smoking cessation or reduction during pregnancy

iv. E-cigarette use

Related Conditions & MeSH terms

• Disease
• Pregnancy Complications
• Substance-Related Disorders
• Tobacco Smoking
• Tobacco Smoking in Mother Complicating Pregnancy
• Tobacco Use Disorder

Intervention

Diagnostic Test:
• knowledge of expired maternal carbon monoxide and fetal carboxyhemoglobin levels
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.

Locations

Country	Name	City	State
United States	University of Alabama	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

References & Publications (14)

11. Bedfont. Smokerlyzer range user manual. http://www.bedfont.com/file.php?f=ZmlsZSMjMTgxMg. Updated 2019. Accessed Sept 16, 2019.

Bedfont. Smokerlyzer range user manual. http://www.bedfont.com/file.php?f=ZmlsZSMjMTgxMg. Updated 2019. Accessed Sept 16, 2016.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expired maternal carbon monoxide level	1. 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	Through study completion, an average of 10 months
Primary	Expired maternal carbon monoxide level at delivery	2. Prevalence of smoking = 10 cigarettes/day in each group at final measurement by exhaled carbon monoxide level at delivery, as measured by exhaled carbon monoxide	Through study completion, an average of 10 months
Secondary	Infant birthweight		Through study completion, an average of 10 months
Secondary	APGAR at 5 minutes		Through study completion, an average of 10 months
Secondary	Average number of cigarettes smoked/day in each group, as measured by exhaled carbon monoxide at final measurement		Through study completion, an average of 10 months
Secondary	Prevalence of smoking =10 cigarettes/day in each group at delivery, per patient report		Through study completion, an average of 10 months
Secondary	Average number of cigarettes smoked/day in each group, per patient report		At delivery
Secondary	Average exhaled carbon monoxide at final measurement		Through study completion, an average of 10 months
Secondary	Average percent fetal carboxyhemoglobin at final measurement		At delivery
Secondary	Small for gestational age at birth (<10th percentile)		Through study completion, an average of 10 months
Secondary	Infant birth weight as a function of carboxyhemoglobin in pregnancy (first and last measured; average of all measurements in intervention group)		Through study completion, an average of 10 months
Secondary	Patient satisfaction at final prenatal visit, measured by PANAS scales (positive and negative affect scales) and select questions at last visit or delivery on Stop Smoking Service Client Satisfaction Survey		Through study completion, an average of 10 months

External Links

•   Smokerlyzer product website