Low Nicotine Content Cigarettes in Vulnerable Populations: Affective Disorders

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]).

Study Overview

• Status: Active, not recruiting
• Conditions: Tobacco Use Disorder
• Intervention / Treatment: Other: Either normal nicotine content cigarettes (15.8mg/g) or reduced nicotine content cigarettes (0.4mg/g); Other: E-Cigarettes

• Study Type: Interventional
• Enrollment (Estimated): 232
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Shirley Plucinski; Phone Number: 9788752361; Email: shirley.plucinski@uvm.edu

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02912
      • Brown University
  • Vermont
    • Burlington, Vermont, United States, 05401
      • University of Vermont

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RC 1 only; Research Cigarettes #1	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
Experimental: RC 2 only; Research Cigarettes #2	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
Experimental: RC 2 + EC 1; 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); 1) Altering the nicotine content of the tobacco research cigarette; Other: E-Cigarettes; 1) Altering the availability of e-cigarettes; 2) Altering option to personalize the e-liquid in the e-cig condition
Experimental: RC 2 + EC 2; 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); 1) Altering the nicotine content of the tobacco research cigarette; Other: E-Cigarettes; 1) Altering the availability of e-cigarettes; 2) Altering option to personalize the e-liquid in the e-cig condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cigarettes Per Day	16 weeks

Collaborators and Investigators

• Sponsor: Brown University
• Collaborators: National Institute on Drug Abuse (NIDA); University of Vermont; Food and Drug Administration (FDA)
• Investigators: Principal Investigator: Jennifer W Tidey, Ph.D., Brown University

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2019
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): January 1, 2024

Study Registration Dates

• First Submitted: September 13, 2019
• First Submitted That Met QC Criteria: September 13, 2019
• First Posted (Actual): September 16, 2019

Study Record Updates

• Last Update Posted (Actual): August 18, 2023
• Last Update Submitted That Met QC Criteria: August 16, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Nicotine Dependence; Affective Disorders; Biomarkers of Exposure; Compensatory Smoking; Reduced Nicotine Cigarettes; Tobacco Withdrawal; Vulnerable Populations; E-Cigarettes
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Mood Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: CHRMS19-0129; U54DA036114-06 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No