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

• ClinicalTrials.gov Identifier: NCT02250534
• Recruitment Status: Completed
• First Posted: September 26, 2014
• Last Update Posted: June 11, 2020
• Sponsor: University of Vermont
• 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

• 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

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 :

1. Cigarettes per day [ Time Frame: 12 weeks ]

Eligibility Criteria

• 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

Locations

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

• 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):

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.

• 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
• 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:

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