Project 1, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Childbearing Age Women
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Smoking Cessation, Tobacco Consumers |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 44 |
| Updated: | 4/2/2016 |
| Start Date: | August 2015 |
| End Date: | August 2019 |
| Contact: | Hanna Durand, MSN, RN |
| Email: | hanna.durand@uvm.edu |
| Phone: | 802-656-8859 |
This study will examine extended exposure to cigarettes varying in nicotine content among
disadvantaged women. Disadvantaged women are at increased risk for smoking, nicotine
dependence, and using high nicotine yield cigarettes and are also at significantly increased
risk for smoking-related adverse health consequences, including cervical cancer, thrombosis
related to hormone-based contraception, infertility, and early menopause. Studies testing an
innovative regulatory strategy of reducing the nicotine content of cigarettes to a
non-addictive level have shown promising beneficial effects (decreased smoking rate, reduced
toxicant exposure, and increased cessation) in the general population of smokers. However,
these studies have uniformly excluded vulnerable populations like disadvantaged worn who may
respond differently considering their greater vulnerability to smoking and nicotine
dependence. Thus, little is known scientifically about how this highly vulnerable subgroup
of smokers might respond to a nicotine reduction policy. This project is designed to address
that substantial knowledge gap.
disadvantaged women. Disadvantaged women are at increased risk for smoking, nicotine
dependence, and using high nicotine yield cigarettes and are also at significantly increased
risk for smoking-related adverse health consequences, including cervical cancer, thrombosis
related to hormone-based contraception, infertility, and early menopause. Studies testing an
innovative regulatory strategy of reducing the nicotine content of cigarettes to a
non-addictive level have shown promising beneficial effects (decreased smoking rate, reduced
toxicant exposure, and increased cessation) in the general population of smokers. However,
these studies have uniformly excluded vulnerable populations like disadvantaged worn who may
respond differently considering their greater vulnerability to smoking and nicotine
dependence. Thus, little is known scientifically about how this highly vulnerable subgroup
of smokers might respond to a nicotine reduction policy. This project is designed to address
that substantial knowledge gap.
Inclusion Criteria:
- Female
- Ages 18-44 years
- Less than or equal to 12 years of education
- Not interested in quitting smoking in the next three months
- Report smoking more than 10 cigarettes per day for the past year
- Provide an intake breath CO sample greater than 8ppm
- Without current serious mental illness or current substance abuse/dependence other
than nicotine
- Be sufficiently literate to complete research-related tasks
- Be in good physical health without serious illness or change in health in the past
three months
- Not pregnant or nursing
- Report no use of other tobacco or nicotine products within the past month
Exclusion Criteria:
- Any prior use of Spectrum cigarettes (i.e., research cigarettes with reduced nicotine
content)
- Exclusive use of roll-your-own cigarettes
- Taking anticonvulsant medications
- Positive toxicology screen for illicit drugs
- An expired breath sample that tests positive for recent alcohol use
- Regular binge drinking (greater than 9 days in past 30, 4 drinks in 2 hours in
females)
- Systolic blood pressure <90 or >160
- Diastolic blood pressure <50 or >100
- Breath CO >80
- Heart rate >115 bpm
- Heart rate <45 bpm and symptomatic
- Suicidal ideation in the past two weeks
- Suicide attempt in past ten years
- Score of >4 on MINI suicide sub scale
- Participation in another smoking study in the past 90 days
We found this trial at
2
sites
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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University of Vermont The University of Vermont combines faculty-student relationships most commonly found in a...
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