Project 1, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Childbearing Age Women
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ClinicalTrials.gov Identifier: NCT02250534 |
Recruitment Status :
Completed
First Posted : September 26, 2014
Last Update Posted : June 11, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Tobacco Use Disorder | Other: Very low nicotine content cigarettes | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated 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 : | October 2016 |
Actual Primary Completion Date : | October 2019 |
Actual Study Completion Date : | October 2019 |

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 |
- Cigarettes per day [ Time Frame: 12 weeks ]

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Ages Eligible for Study: | 18 Years to 44 Years (Adult) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02250534
United States, Maryland | |
Johns Hopkins University | |
Baltimore, Maryland, United States, 21224 | |
United States, Vermont | |
University of Vermont | |
Burlington, Vermont, United States, 05401 |
Study Director: | Stephen T. Higgins, Ph.D. | University of Vermont | |
Principal Investigator: | Sarah H. Heil, Ph.D. | University of Vermont |
Responsible Party: | Stephen T. Higgins, PhD, Professor, University of Vermont |
ClinicalTrials.gov Identifier: | NCT02250534 |
Other Study ID Numbers: |
P50DA036114:P1S2 P50DA036114 ( U.S. NIH Grant/Contract ) |
First Posted: | September 26, 2014 Key Record Dates |
Last Update Posted: | June 11, 2020 |
Last Verified: | October 2016 |
Biomarkers of exposure Compensatory smoking Nicotine dependence Reduced nicotine cigarettes |
Tobacco withdrawal Women Health disparities Vulnerable populations |
Tobacco Use Disorder Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Nicotine Ganglionic Stimulants Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |