The Effect of Electronic Cigarette Use on Smoking Behaviors Among Smokers Receiving Outpatient Psychiatric Treatment

The Effect of Electronic Cigarette Use on Smoking Behaviors and Smoking-related Factors Among Smokers Receiving Outpatient Psychiatric Treatment

This study aims to establish the feasibility and acceptability of a project designed to investigate the impact of electronic cigarette use on combustible cigarette smoking and smoking-related factors among smokers with psychiatric disorders, a high-risk population, who are not yet ready to quit smoking. All participants will be instructed to switch completely from combustible cigarettes to e-cigarettes for the next 8 weeks. They will be assessed at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks.

Study Overview

• Status: Recruiting
• Conditions: Tobacco Smoking; Psychiatric Disorders
• Intervention / Treatment: Other: E-cigarette

Detailed Description

In recent years, the prevalence of e-cigarette use has rapidly increased, especially among those with psychiatric conditions, and the risks and potential benefits of e-cigarette use have been the topic of much debate. More research is needed to understand the impact of e-cigarette use on smoking behavior and smoking-related cognitions among individuals with psychiatric conditions.

This study will investigate the effects of e-cigarette use on cigarette smoking and motivation/readiness to quit among smokers with psychiatric disorders who are not yet ready to quit smoking. A total of 50 adult daily cigarette smokers who are receiving outpatient psychiatric treatment and not yet ready to quit smoking will be recruited. All participants will be instructed to switch completely from combustible cigarettes to e-cigarettes for the next 8 weeks. E-cigarettes will be provided to participants at no cost. Participants will also be asked to complete 5 (remote and in-person) assessment sessions (i.e., baseline, 2-week, 4-week, 8-week and 12-week follow-ups).

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Haruka Minami, Ph.D.; Phone Number: (718) 817-3885; Email: hminami@fordham.edu

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10461
      • Recruiting
      • Montefiore Behavioral Health Center
      • Contact: Haruka Minami, Ph.D.; Phone Number: 718-817-3885; Email: hminami@fordham.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 21 years of age or older
• English-speaking,
• current daily smokers (i.e., at least 5 cigarettes/day)
• have been daily smokers at least for 6 months
• attended a minimum of 2 treatment visits in the past 12 months at Montefiore Behavioral Health Center
• have at least one psychiatric disorder (other than substance use disorders),
• willing to try switching to use e-cigarettes (provided by the research team) exclusively for a total of 8 weeks,
• those who are not yet ready to quit smoking,
• for women of childbearing age, willingness to use contraception during the study.

Exclusion Criteria:

• acute psychiatric symptomatology which precludes study participation including current active suicidal ideation
• current diagnosis of dementia or cognitive impairment sufficient to impair provision of informed consent or study participation
• patient's inability to provide consent for study participation due to his/her inability to demonstrate an understanding of study procedures as contained in the statement of informed consent, after no more than two explanations
• current clinical diagnosis of intellectual development disorder
• current regular use of other tobacco products or combustible marijuana
• current (non-nicotine) substance use disorder and current substance use (in the past month)
• current effort to quit smoking or current use of pharmacotherapy (in the past month) to quit smoking,
• pregnant, breastfeeding, or planning to become pregnant within 6 months, current unstable cardiovascular disease,
• current unstable pulmonary disease (i.e., an ER visit or hospitalization due to pulmonary issues in the past 6 month or current use of oxygen therapy),
• patient does not have a stable home address where the research team could reliably reach patient
• household members are currently participating or have participated in this research study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: E-cigarette; All participants will be instructed to switch completely from combustible cigarettes to e-cigarettes for the next 8weeks. They will be assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.

Other: E-cigarette; All participants will be provided with 8 weeks of e-cigarettes at no cost based on self-report of regular cigarette use. All participants will receive a total of 8-10 remote counseling sessions (via phone or video conference) and during which they will discuss ways to switch from smoking cigarettes to exclusively using e-cigarettes, barriers and strategies to overcome them. (All participants will receive sessions at baseline, 2 days, 7 days, 2 weeks, 3 weeks, and 4 weeks, 6 weeks , and 8 weeks after the baseline assessment. Two additional sessions at 5 weeks and 7 weeks (after the baseline assessment) will be provided to those who are still smoking combustible cigarettes at 4-week assessment.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the number of combustible cigarettes smoked per day	The average number of cigarettes smoked per day	Baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks
Changes in Carbon Monoxide Level	Changes in Carbon monoxide level measured with a breath carbon monoxide monitor	Baseline,2 weeks, 4 weeks, 8 weeks, 12 weeks
Changes in Nicotine Dependence	Fagerstrom Test of Cigarette Dependence	Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks
Changes in the use of e-cigarettes	Changes in the use of e-cigarettes	Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks
Rates of those who completely switched to e-cigarettes	Rates of those who completely switched to e-cigarettes	Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Motivation/Readiness to Quit Smoking	Thoughts about Abstinence Scale & Contemplation Ladder	Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks
Changes in Withdrawal Symptoms	Minnesota Nicotine Withdrawal Scale	Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks

Collaborators and Investigators

• Sponsor: Fordham University
• Collaborators: Montefiore Medical Center; Dartmouth College
• Investigators: Principal Investigator: Haruka Minami, Ph.D., Fordham University

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2020
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: July 8, 2019
• First Submitted That Met QC Criteria: July 8, 2019
• First Posted (Actual): July 10, 2019

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: September 15, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: smoking behavior; electronic cigarette use
• Additional Relevant MeSH Terms: Behavioral Symptoms; Problem Behavior; Mental Disorders
• Other Study ID Numbers: 1089

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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