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

NCT ID: NCT04092387

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 326 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-18
• Study Completion Date: 2023-11-27

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

RC 1 only

Research cigarettes #1

Group Type: EXPERIMENTAL

Varying the nicotine content of cigarettes

Intervention Type: OTHER

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

RC 2 only

Research Cigarettes #2

Group Type: EXPERIMENTAL

Varying the nicotine content of cigarettes

Intervention Type: OTHER

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

RC 2 + EC 1

Research Cigarettes #2 plus E-cigarettes #1

Group Type: EXPERIMENTAL

Varying the nicotine content of cigarettes

Intervention Type: OTHER

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

E-Cigarettes

Intervention Type: OTHER

Comparing effects of combining RC2 with EC 1 versus EC2

RC 2 + EC 2

Research Cigarettes #2 plus E-cigarettes #2

Group Type: EXPERIMENTAL

Varying the nicotine content of cigarettes

Intervention Type: OTHER

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

E-Cigarettes

Intervention Type: OTHER

Comparing effects of combining RC2 with EC 1 versus EC2

Interventions

Varying the nicotine content of cigarettes

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

Intervention Type: OTHER

E-Cigarettes

Comparing effects of combining RC2 with EC 1 versus EC2

Intervention Type: OTHER

Other Intervention Names

Comparing normal nicotine content (RC1) to very low nicotine content (RC2); e-cigarette with only tobacco flavor (EC 1); e-cigarette in multiple flavors ( EC2)

Eligibility Criteria

Inclusion Criteria

• Female
• 21 to 44 years old

Exclusion Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Food and Drug Administration (FDA)

FED

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: collaborator

University of Vermont

OTHER

Sponsor Role: lead

Responsible Party

Stephen T. Higgins, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen T. Higgins, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Vermont

Locations

Johns Hopkins University

Baltimore, Maryland, United States

University of Vermont

Burlington, Vermont, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39240566 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

U54DA036114-06

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CHRMS19-0129

Identifier Type: -

Identifier Source: org_study_id