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

Tracking Information

• First Submitted Date: September 23, 2014
• First Posted Date: September 26, 2014
• Last Update Posted Date: June 11, 2020
• Study Start Date: October 2016
• Actual Primary Completion Date: October 2019 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 23, 2014): Cigarettes per day [ Time Frame: 12 weeks ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Project 1, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Childbearing Age Women
• Official Title: Project 1, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Childbearing Age Women
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Basic Science
• Condition: Tobacco Use Disorder
• Intervention: Other: Very low nicotine content cigarettes

Study Arms

• Experimental: 0.8 mg nicotine
  0.8 mg nicotine very low nicotine content cigarettes
  Intervention: Other: Very low nicotine content cigarettes
• Experimental: 0.12 mg nicotine
  0.12 mg nicotine very low nicotine content cigarettes
  Intervention: Other: Very low nicotine content cigarettes
• Experimental: 0.03 mg nicotine
  0.03 mg nicotine very low nicotine content cigarettes
  Intervention: Other: Very low nicotine content cigarettes

Publications *

• 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.

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: October 5, 2016): 282
• Original Estimated Enrollment (submitted: September 23, 2014): 405
• Actual Study Completion Date: October 2019
• Actual Primary Completion Date: October 2019 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 44 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02250534
• Other Study ID Numbers: P50DA036114:P1S2; P50DA036114 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Stephen T. Higgins, PhD, University of Vermont
• Study Sponsor: University of Vermont

Collaborators

• 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

• PRS Account: University of Vermont
• Verification Date: October 2016