Low Nicotine Content Cigarettes in Vulnerable Populations: Affective Disorders

Tobacco Use Disorder Clinical Trial

Official title:

Low Nicotine Content Cigarettes in Vulnerable Populations: Affective Disorders

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04090879
• Other study ID #: CHRMS19-0129
• Secondary ID: U54DA036114-06
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 18, 2019
• Est. completion date: January 2024

Study information

• Verified date: August 2023
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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]).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 232
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Mood Disorders
• Tobacco Use Disorder

Intervention

Other:
• 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
• E-Cigarettes
1) Altering the availability of e-cigarettes; 2) Altering option to personalize the e-liquid in the e-cig condition

Locations

Country	Name	City	State
United States	University of Vermont	Burlington	Vermont
United States	Brown University	Providence	Rhode Island

Sponsors (4)

Lead Sponsor	Collaborator
Brown University	Food and Drug Administration (FDA), National Institute on Drug Abuse (NIDA), University of Vermont

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cigarettes Per Day		16 weeks