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

NCT02250534 | Completed Phase 1 Results DMC

• 2 other identifiers: P50DA036114:P1S2P50DA036114
• Study Type: interventional
• Target: 775
• Locations: 1 country
• Sites: 2

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 women 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. This same study was also conducted in two additional vulnerable populations under a similar protocol.

Conditions

Tobacco Use Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Cigarettes Per Day (CPD)

  Participant reported number of cigarettes smoked per day at Week 12.

  12 weeks

Study Arms (3)

0.8 mg nicotine

EXPERIMENTAL

0.8 mg nicotine very low nicotine content cigarettes

Other: Very low nicotine content cigarettes

0.12 mg nicotine

EXPERIMENTAL

0.12 mg nicotine very low nicotine content cigarettes

Other: Very low nicotine content cigarettes

0.03 mg nicotine

EXPERIMENTAL

0.03 mg nicotine very low nicotine content cigarettes

Other: Very low nicotine content cigarettes

Interventions

Very low nicotine content cigarettes OTHER

0.03 mg nicotine; 0.12 mg nicotine; 0.8 mg nicotine

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female
• Ages 18-44 years
• Less than an Associate's degree
• Report smoking ≥ 5 cigarettes per day
• Provide an intake breath carbon monoxide (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, intrauterine device (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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Vermont: lead
• Johns Hopkins University: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

University of Vermont

Burlington, Vermont, 05401, United States

Location

Related Publications (6)

• Harfmann RF, Heil SH, Bunn JY, Snell LM, Tidey JW, Sigmon SC, Gaalema DE, Lee DC, Streck JM, Bergeria CL, Davis DR, Plucinski S, Higgins ST. Changes in weight among individuals with psychiatric conditions or socioeconomic disadvantage assigned to smoke very low nicotine content cigarettes. Exp Clin Psychopharmacol. 2024 Apr;32(2):181-188. doi: 10.1037/pha0000700. Epub 2024 Jan 18.

  PMID: 38236223 DERIVED

• Gaalema DE, Snell LM, Tidey JW, Sigmon SC, Heil SH, Lee DC, Bunn JY, Park C, Hughes JR, Higgins ST. Potential effects of nicotine content in cigarettes on use of other substances. Prev Med. 2022 Dec;165(Pt B):107290. doi: 10.1016/j.ypmed.2022.107290. Epub 2022 Oct 5.

  PMID: 36208817 DERIVED

• 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.

  PMID: 34255068 DERIVED

• 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.

  PMID: 34242666 DERIVED

• 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.

  PMID: 33079196 DERIVED

• 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.

  PMID: 32628945 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Stephen T. Higgins, PhD, Professor, Department of Psychiatry
• Organization: University of Vermont

stephen.higgins@uvm.edu

802-735-6267

Study Officials

• Stephen T. Higgins, Ph.D.

  University of Vermont

  STUDY DIRECTOR

• Sarah H. Heil, Ph.D.

  University of Vermont

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This study was one of three multi-site clinical trials conducted in three different vulnerable populations under a similar protocol, with differences between protocols consisting of data collection specific to that vulnerable population. This included information such as use and timing of opioid maintenance therapy for individuals with opioid-use disorder or additional assessments of anxiety and depression for individuals with affective disorders. In order to explore potential differences across individuals with different vulnerabilities, data from all three studies were combined for analysis. A vulnerable population-by-condition or population-by- condition-by-time interaction term was included in all analyses. In the event that these interaction terms were statistically significant, all pairwise comparisons were conducted using a Bonferroni multiple comparison adjustment. Please see Statistical Analysis Plan for more details.

Study Record Dates

• First Submitted: September 23, 2014
• First Posted: September 26, 2014
• Study Start: October 1, 2016
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: December 1, 2022
• Results First Posted: December 1, 2022

Record last verified: 2022-11

Locations

US (2)