Status:
COMPLETED
Project 1, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Childbearing Age Women
Lead Sponsor:
University of Vermont
Collaborating Sponsors:
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Conditions:
Tobacco Use Disorder
Eligibility:
FEMALE
18-44 years
Phase:
PHASE1
PHASE2
Brief 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 hig...
Detailed Description
The primary overall objective of these studies is to evaluate the effects of extended exposure to cigarettes differing in nicotine content in socioeconomically disadvantaged (\< high school educationa...
Eligibility Criteria
Inclusion
- 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
- 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 \< 90 or ≥ 160 mmHg (participants outside the range will be allowed to re-screen once)
- Diastolic blood pressure \< 50 or ≥ 100 mmHg (participants outside the range will be allowed to re-screen once)
- Breath CO \> 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
Key Trial Info
Start Date :
October 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2019
Estimated Enrollment :
775 Patients enrolled
Trial Details
Trial ID
NCT02250534
Start Date
October 1 2016
End Date
October 1 2019
Last Update
December 1 2022
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Johns Hopkins University
Baltimore, Maryland, United States, 21224
2
University of Vermont
Burlington, Vermont, United States, 05401