Project 1, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Childbearing Age Women

Sponsor

University of Vermont (Other)

Overall Status

Completed

CT.gov ID

NCT02250534

Collaborator

National Institute on Drug Abuse (NIDA) (NIH), Johns Hopkins University (Other)

282

Enrollment

Locations

Arms

Duration (Months)

141

Patients Per Site

3.9

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Tobacco Use Disorder	Other: Very low nicotine content cigarettes	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

282 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

Project 1, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Childbearing Age Women

Study Start Date :

Oct 1, 2016

Actual Primary Completion Date :

Oct 1, 2019

Actual Study Completion Date :

Oct 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 0.8 mg nicotine 0.8 mg nicotine very low nicotine content cigarettes	Other: Very low nicotine content cigarettes
Experimental: 0.12 mg nicotine 0.12 mg nicotine very low nicotine content cigarettes	Other: Very low nicotine content cigarettes
Experimental: 0.03 mg nicotine 0.03 mg nicotine very low nicotine content cigarettes	Other: Very low nicotine content cigarettes

Arm

Intervention/Treatment

Experimental: 0.8 mg nicotine

0.8 mg nicotine very low nicotine content cigarettes

Other: Very low nicotine content cigarettes

Experimental: 0.12 mg nicotine

0.12 mg nicotine very low nicotine content cigarettes

Other: Very low nicotine content cigarettes

Experimental: 0.03 mg nicotine

0.03 mg nicotine very low nicotine content cigarettes

Other: Very low nicotine content cigarettes

Outcome Measures

Primary Outcome Measures

Cigarettes per day [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 44 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Female
Ages 18-44 years
Less than an Associate's degree
Report smoking ≥ 5 cigarettes per day
Provide an intake breath 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, 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 < 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