Phase 2
N=775
Project 1, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Childbearing Age Women
Tobacco Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02250534 ↗Enrolled (actual)
775
Serious AEs
3.9%
Results posted
Dec 2022
Primary outcome: Primary: Cigarettes Per Day (CPD) — 25.28; 19.95; 17.74 cigarettes per day — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Very low nicotine content cigarettes (Other)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Vermont
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cigarettes Per Day (CPD) |
25.28; 19.95; 17.74 | <0.0001 sig |
Summary
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 women 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. This same study was also conducted in two additional vulnerable populations under a similar protocol.
Eligibility Criteria
Inclusion Criteria
- Female
- Ages 18-44 years
- Less than an Associate's degree
- Report smoking ≥ 5 cigarettes per day
- Provide an intake breath carbon monoxide (CO) sample > 8 ppm
- Be without current (within the past year) serious mental disorder that would interfere with study results or completion as determined by the Licensed Medical Professional or PI
- Be without 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 or medication in the past three months as determined by the Licensed Medical Professional at each site
- Not pregnant or nursing and report using oral, implant, patch, ring, intrauterine device (IUD), injection, or barrier contraceptives or report being surgically sterile, or post menopausal
- Report no significant use of other tobacco or nicotine products within the past month (> 9 days in the past 30)
Exclusion Criteria
- Any prior regular use (used as primary cigarette outside of the laboratory) of Spectrum cigarettes (i.e., research cigarettes with reduced nicotine content)
- Exclusive use of roll-your-own cigarettes
- Planning to quit smoking in the next 30 days
- A quit attempt in the past 30 days resulting in > 3 days of abstinence
- Currently taking anticonvulsant medications
- Positive toxicology screen for illicit drugs not including marijuana (participants with valid prescriptions will not be excluded and participants with a positive toxicology screen will be allowed to re-screen once)
- Breath alcohol level > 0.01 (participants with a positive screen will be allowed to re-screen once)
- Self-report of binge drinking alcohol (> 9 days in past 30, 4 drinks in 2 hours )
- Systolic blood pressure 80 ppm
- Heart rate < 45 or ≥ 115 bpm (participants outside the range will be allowed to re-screen once)
- Currently seeking treatment for smoking cessation
- Have used nicotine replacement, bupropion or other pharmacotherapies as cessation aids in the past month (bupropion for treatment of depression will be allowed)
- Current symptoms of psychosis, dementia or mania
- Suicidal ideation in the past month
- Suicide attempt in past 6 months
- Participation in another research study in the past 30 days
Data sourced from ClinicalTrials.gov (NCT02250534). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.