Clinical trial NCT04090879: Low Nicotine Content Cigarettes in Vulnerable Populations: Affective Disorders
Official title: Low Nicotine Content Cigarettes in Vulnerable Populations: Affective Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tobacco Use Disorder
Keywords: Biomarkers of Exposure
Compensatory Smoking
Nicotine Dependence
Reduced Nicotine Cigarettes
Affective Disorders
Tobacco Withdrawal
Vulnerable Populations
E-Cigarettes
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: Food and Drug Administration (FDA)
name: National Institute on Drug Abuse (NIDA)
name: University of Vermont
First posted: 2019-09-16
Enrollment: 326
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized parallel groups research design
Primary purpose: BASIC_SCIENCE

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 \[FeNO\]).


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

Primary outcomes:
measure: Cigarettes Per Day
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown University
state: Rhode Island
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
affiliation: Brown University
name: Jennifer W Tidey, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: