Low Nicotine Content Cigarettes in Vulnerable Populations: Women of Reproductive Age

NCT04092387 | Completed Results DMC

• 2 other identifiers: CHRMS19-0129U54DA036114-06
• Study Type: interventional
• Target: 326
• Locations: 1 country
• Sites: 2

Brief Summary

Despite marked reductions in cigarette smoking in the general population, smoking among economically disadvantaged women has increased. Smoking among women of reproductive age is a particular concern because in addition to the usual health risks, there are additional risks should they become pregnant. A national nicotine reduction policy for cigarettes has considerable potential to reduce tobacco use, dependence, and improve health in this population. Controlled trials in general population samples have demonstrated that reducing the nicotine content in cigarettes can reduce cigarettes per day (CPD), dependence severity, and tobacco toxicant exposure. The goal of the proposed trial is to experimentally examine whether increasing the availability and appeal of an alternative, non-combusted source of nicotine (e-cigarettes) enhances the effect of altering the nicotine in cigarettes in non-pregnant female cigarette smokers of childbearing age. Additionally, investigators will test whether allowing participants to personalize the flavor of the e-liquid alters any moderating effects their availability may have on tobacco cigarette smoking. Daily smokers who are female, aged 21-44 years, and have a maximum educational attainment of graduating high school, will be recruited at Johns Hopkins University and the University of Vermont. Investigators will study two research cigarettes referred to here as Research Cigarettes 1 (RC1) and Research Cigarettes 2 (RC2). One will be a normal nicotine content cigarette and the other a reduced nicotine content cigarette. Investigators will study two e-cigarette conditions referred to here as E-Cigarette Condition 1 (EC1) and E-Cigarette Condition 2 (EC2). Both e-cigarette conditions will involve the same commercially available devices and same nicotine-containing e-liquid, but in one condition that e-liquid will be available only in tobacco flavor while in the other the e-liquid will be available in multiple flavors from which participants can choose three based on personal preference. Participants will be assigned to one of the following four conditions: (1) RC1 only; (2) RC2 only; (3) RC2 + EC1; (4) RC2 + EC2. Participants will be asked to use only their assigned study products for 16 weeks. Outcome measures include total CPD, craving, withdrawal, psychiatric symptoms, breath carbon monoxide (CO), other biomarkers of tobacco toxicant exposure, and cigarette demand assessed by behavioral economic purchase tasks.

Conditions

Tobacco Use Disorder

Keywords

Biomarkers of Exposure; Nicotine Dependence; Reduced Nicotine Cigarettes; Tobacco Withdrawal; Women; Health Disparities; Vulnerable Populations; E-Cigarettes

Outcome Measures

Primary Outcomes (1)

• Number of Cigarettes Smoked Per Day

  Cigarettes per day will be assessed for use of cigarettes with different nicotine content.

  16 weeks

Study Arms (4)

RC 1 only

EXPERIMENTAL

Research cigarettes #1

Other: Varying the nicotine content of cigarettes

RC 2 only

EXPERIMENTAL

Research Cigarettes #2

Other: Varying the nicotine content of cigarettes

RC 2 + EC 1

EXPERIMENTAL

Research Cigarettes #2 plus E-cigarettes #1

Other: Varying the nicotine content of cigarettes; Other: E-Cigarettes

RC 2 + EC 2

EXPERIMENTAL

Research Cigarettes #2 plus E-cigarettes #2

Other: Varying the nicotine content of cigarettes; Other: E-Cigarettes

Interventions

Varying the nicotine content of cigarettes OTHER

1\) Altering the nicotine content of the tobacco research cigarettes

Also known as: Comparing normal nicotine content (RC1) to very low nicotine content (RC2)

RC 1 only; RC 2 + EC 1; RC 2 + EC 2; RC 2 only

E-Cigarettes OTHER

Comparing effects of combining RC2 with EC 1 versus EC2

Also known as: e-cigarette with only tobacco flavor (EC 1); e-cigarette in multiple flavors ( EC2)

RC 2 + EC 1; RC 2 + EC 2

Eligibility Criteria

• Age: 21 Years - 44 Years
• Gender Eligibility Details: Participants must be female.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female
• to 44 years old

You may not qualify if:

• Male
• Under 21 years old
• Over 44 years old

Sponsors & Collaborators

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

Study Sites (2)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

University of Vermont

Burlington, Vermont, 05401, United States

Location

Related Publications (1)

• Higgins ST, Sigmon SC, Tidey JW, Heil SH, Gaalema DE, Lee DC, DeSarno MJ, Klemperer EM, Menson KE, Cioe PA, Plucinski S, Wiley RC, Orr E. Reduced Nicotine Cigarettes and E-Cigarettes in High-Risk Populations: 3 Randomized Clinical Trials. JAMA Netw Open. 2024 Sep 3;7(9):e2431731. doi: 10.1001/jamanetworkopen.2024.31731.

  PMID: 39240566 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder; Vaping

Interventions

Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

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

stephen.higgins@uvm.edu

802-735-6267

Study Officials

• Stephen T. Higgins, Ph.D.

  University of Vermont

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind dosing of tobacco cigarette nicotine content levels.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized parallel groups research design.

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: September 17, 2019
• Study Start: October 18, 2020
• Primary Completion: November 27, 2023
• Study Completion: November 27, 2023
• Last Updated: March 18, 2025
• Results First Posted: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be made available once we have published the results of the parent trials and manuscripts based on secondary analyses of those data, which we anticipate taking approximately three years
• Access Criteria: request data for stated scientific purpose

Locations

US (2)