Low Nicotine Content Cigarettes in Vulnerable Populations: Affective Disorders

NCT ID: NCT04090879

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 326 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-18
• Study Completion Date: 2023-11-27

Brief Summary

While the prevalence of smoking in the United States general population has declined over the past 50 years, there has been little to no decline among people with mental health conditions. Affective Disorders (ADs) are the most common mental health conditions in the US, and over 40% of people with ADs are current smokers. A national policy of reducing the nicotine content of cigarettes has the potential to reduce tobacco use, dependence, and related adverse health outcomes. Controlled trials in psychiatrically-stable smokers have shown that reducing the nicotine content in cigarettes can reduce cigarettes per day (CPD), dependence and tobacco toxicant exposure, with few adverse consequences.

The goal of the proposed trial is to experimentally model whether increasing the availability and appeal of an alternative, non-combusted source of nicotine (e-cigarettes) moderates the effect of altering the nicotine in cigarettes in smokers with ADs. 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 with current ADs will be recruited at Brown University and the University of Vermont.

Investigators will study two research cigarettes referred to here as Research Cigarette 1 (RC1) and Research Cigarette 2 (RC2). One of these cigarettes will be a normal nicotine content cigarette and the other will be 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 condition that e-liquid will be available in multiple flavors from which participants can choose based on personal taste preference. Participants will be assigned to one of the following four study 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, cigarette demand assessed by behavioral economics-based purchase tasks, craving, withdrawal, psychiatric symptoms, breath carbon monoxide (CO), biomarkers of tobacco toxicant exposure, brain function and structure, and airway inflammation (fractional nitric oxide concentration in exhaled breath [FeNO]).

Conditions

Tobacco Use Disorder

Study Design

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

Study Groups

RC 1 only

Research Cigarettes #1

Group Type: EXPERIMENTAL

Either normal nicotine content cigarettes (15.8mg/g) or reduced nicotine content cigarettes (0.4mg/g)

Intervention Type: OTHER

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

RC 2 only

Research Cigarettes #2

Group Type: EXPERIMENTAL

Either normal nicotine content cigarettes (15.8mg/g) or reduced nicotine content cigarettes (0.4mg/g)

Intervention Type: OTHER

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

RC 2 + EC 1

Research Cigarettes #2 plus E-cigarettes #1 (participants receive tobacco flavor only)

Group Type: EXPERIMENTAL

Either normal nicotine content cigarettes (15.8mg/g) or reduced nicotine content cigarettes (0.4mg/g)

Intervention Type: OTHER

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

E-Cigarettes

Intervention Type: OTHER

1\) Altering the availability of e-cigarettes; 2) Altering option to personalize the e-liquid in the e-cig condition

RC 2 + EC 2

Research Cigarettes #2 plus E-cigarettes #2 (participants can choose among varying flavors)

Group Type: EXPERIMENTAL

Either normal nicotine content cigarettes (15.8mg/g) or reduced nicotine content cigarettes (0.4mg/g)

Intervention Type: OTHER

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

E-Cigarettes

Intervention Type: OTHER

1\) Altering the availability of e-cigarettes; 2) Altering option to personalize the e-liquid in the e-cig condition

Interventions

Either normal nicotine content cigarettes (15.8mg/g) or reduced nicotine content cigarettes (0.4mg/g)

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

Intervention Type: OTHER

E-Cigarettes

1\) Altering the availability of e-cigarettes; 2) Altering option to personalize the e-liquid in the e-cig condition

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Between 21 years and 70 years old
• Must have current diagnosis of an Affective Disorder.

Exclusion Criteria

• Being without an Affective Disorder
• Younger than 21 years old
• Older than 70 years old

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Food and Drug Administration (FDA)

FED

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Vermont

OTHER

Sponsor Role: collaborator

Brown University

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Tidey

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer W Tidey, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Brown University

Locations

Brown University

Providence, Rhode Island, 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