Low Nicotine Content Cigarettes in Vulnerable Populations: Affective Disorders

Study Overview
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Brief Summary
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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]).

Official Title
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Low Nicotine Content Cigarettes in Vulnerable Populations: Affective Disorders

Conditions
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Tobacco Use Disorder

Intervention / Treatment
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* Other: Either normal nicotine content cigarettes (15.8mg/g) or reduced nicotine content cigarettes (0.4mg/g)
* Other: E-Cigarettes


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized parallel groups research design
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RC 1 only<br>Research Cigarettes #1 | Other: Either normal nicotine content cigarettes (15.8mg/g) or reduced nicotine content cigarettes (0.4mg/g)<br>* 1) Altering the nicotine content of the tobacco research cigarette<br>|
| Experimental: RC 2 only<br>Research Cigarettes #2 | Other: Either normal nicotine content cigarettes (15.8mg/g) or reduced nicotine content cigarettes (0.4mg/g)<br>* 1) Altering the nicotine content of the tobacco research cigarette<br>|
| Experimental: RC 2 + EC 1<br>Research Cigarettes #2 plus E-cigarettes #1 (participants receive tobacco flavor only) | Other: Either normal nicotine content cigarettes (15.8mg/g) or reduced nicotine content cigarettes (0.4mg/g)<br>* 1) Altering the nicotine content of the tobacco research cigarette<br>Other: E-Cigarettes<br>* 1) Altering the availability of e-cigarettes; 2) Altering option to personalize the e-liquid in the e-cig condition<br>|
| Experimental: RC 2 + EC 2<br>Research Cigarettes #2 plus E-cigarettes #2 (participants can choose among varying flavors) | Other: Either normal nicotine content cigarettes (15.8mg/g) or reduced nicotine content cigarettes (0.4mg/g)<br>* 1) Altering the nicotine content of the tobacco research cigarette<br>Other: E-Cigarettes<br>* 1) Altering the availability of e-cigarettes; 2) Altering option to personalize the e-liquid in the e-cig condition<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cigarettes Per Day |  | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biomarkers of Exposure, Compensatory Smoking, Nicotine Dependence, Reduced Nicotine Cigarettes, Affective Disorders, Tobacco Withdrawal, Vulnerable Populations, E-Cigarettes