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

Sponsor:

Collaborators:

National Institute on Drug Abuse (NIDA)

Johns Hopkins University

Information provided by (Responsible Party):

Stephen T. Higgins, PhD, University of Vermont

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

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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

Resource links provided by the National Library of Medicine

Drug Information available for: Nicotine tartrate Nicotine polacrilex

U.S. FDA Resources

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

Outcome Measures

Primary Outcome Measures :

Cigarettes per day [ Time Frame: 12 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 44 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

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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

Locations

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United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21224
United States, Vermont
University of Vermont
Burlington, Vermont, United States, 05401

Sponsors and Collaborators

University of Vermont

National Institute on Drug Abuse (NIDA)

Johns Hopkins University

Investigators

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Study Director:	Stephen T. Higgins, Ph.D.	University of Vermont
Principal Investigator:	Sarah H. Heil, Ph.D.	University of Vermont

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Oliver AC, DeSarno M, Irvin CG, Kaminsky D, Tidey JW, Sigmon SC, Heil SH, Gaalema DE, Lee D, Bunn JY, Davis DR, Streck JM, Gallagher T, Higgins ST. Effects of Reduced Nicotine Content Cigarettes on Fractional Exhaled Nitric Oxide and Self-Reported Respiratory Health Outcomes Among Smokers With Psychiatric Conditions or Socioeconomic Disadvantage. Nicotine Tob Res. 2022 Jan 1;24(1):135-140. doi: 10.1093/ntr/ntab145.

Higgins ST, DeSarno M, Bunn JY, Gaalema DE, Leventhal AM, Davis DR, Streck JM, Harfmann RF, Markesich C, Orr E, Sigmon SC, Heil SH, Tidey JW, Lee D, Hughes JR. Cumulative vulnerabilities as a potential moderator of response to reduced nicotine content cigarettes. Prev Med. 2021 Nov;152(Pt 2):106714. doi: 10.1016/j.ypmed.2021.106714. Epub 2021 Jul 7.

Higgins ST, Tidey JW, Sigmon SC, Heil SH, Gaalema DE, Lee D, Hughes JR, Villanti AC, Bunn JY, Davis DR, Bergeria CL, Streck JM, Parker MA, Miller ME, DeSarno M, Priest JS, Cioe P, MacLeod D, Barrows A, Markesich C, Harfmann RF. Changes in Cigarette Consumption With Reduced Nicotine Content Cigarettes Among Smokers With Psychiatric Conditions or Socioeconomic Disadvantage: 3 Randomized Clinical Trials. JAMA Netw Open. 2020 Oct 1;3(10):e2019311. doi: 10.1001/jamanetworkopen.2020.19311.

Higgins ST, DeSarno M, Davis DR, Nighbor T, Streck JM, Adise S, Harfmann R, Nesheim-Case R, Markesich C, Reed D, Tyndale RF, Gaalema DE, Heil SH, Sigmon SC, Tidey JW, Villanti AC, Lee D, Hughes JR, Bunn JY. Relating individual differences in nicotine dependence severity to underpinning motivational and pharmacological processes among smokers from vulnerable populations. Prev Med. 2020 Nov;140:106189. doi: 10.1016/j.ypmed.2020.106189. Epub 2020 Jul 3.

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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

Keywords provided by Stephen T. Higgins, PhD, University of Vermont:


Biomarkers of exposure Compensatory smoking Nicotine dependence Reduced nicotine cigarettes	Tobacco withdrawal Women Health disparities Vulnerable populations

Additional relevant MeSH terms:

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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

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