A Randomized Clinical Trial of Trans-Dermal Nicotine Replacement in Pregnant African-American Smokers
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We compared acceptability, adherence and efficacy of trans-dermal nicotine patches and cognitive behavioral therapy (Group 1) to cognitive behavioral therapy alone (Group 2) in minority pregnant smokers. This is a randomized controlled trial. 52 women were recruited during pregnancy with a mean gestational age 18.5 ± 5.0 weeks and followed through delivery. Randomization was by site and initial cotinine levels. Interventionists and interviewers were blinded to group assignment. Two different nicotine replacement therapy dosing regiments were administered according to the baseline salivary cotinine level. A process evaluation model summarized patient adherence. The main outcome measure was self-report of cessation since last visit, confirmed by exhaled carbon monoxide. Analyses of categorical and continuous measures were conducted as well as linear trend tests of salivary cotinine levels. Women lost to follow-up were considered treatment failures. Participants were on average 27.5 ± 5.4 years old, 81 % were single, 69 % unemployed and 96 % were Medicaid eligible. A process evaluation indicated patients in both groups were adherent to scheduled program procedures through Visit 4, but not for Visits 5 and 6. Confirmed quit rates were: at visit 3, 23 (Group 1) and 0 % (Group 2) (p = 0.02); at visits 4 and 5, no difference; at visit 6, 19 (Group 1) and 0 % (Group 2) (p = 0.05). Group 1 delivered infants with a mean gestational age of 39.4 weeks versus 38.4 weeks in Group 2 (p = 0.02). 73 % (52/71) of the eligible smokers agreed to participate and 65 % (17/26) of Group 1 completed the protocol (i.e. attended 6 visits). A comparison of Group 1 and 2 quit rates confirmed a non-significant difference.
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- A Randomized Clinical Trial of Trans-Dermal Nicotine Replacement in Pregnant African-American Smokers
Maternal and Child Health Journal
Volume 17, Issue 5 , pp 897-906
- Cover Date
- Print ISSN
- Online ISSN
- Springer US
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- Nicotine replacement therapy
- Industry Sectors
- Author Affiliations
- 1. College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA
- 2. School of Public Health, George Washington University, Washington, DC, USA
- 3. RTI International, Rockville, MD, USA
- 4. Department of Pharmacology and Physiology, George Washington University, Washington, DC, USA
- 5. Epidemiology Branch, Division of Epidemiology, Statistics and Prevention Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, 6100 Executive Blvd, Rm. 7B-05, Rockville, MD, 20852-7510, USA