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

NCT04014322 | Unknown

• 1 other identifier: 1089
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tobacco Smoking; Psychiatric Disorders

Keywords

electronic cigarette use; smoking behavior

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Changes in Motivation/Readiness to Quit Smoking

  Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks

• Changes in Withdrawal Symptoms

  Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks

Study Arms (1)

E-cigarette

EXPERIMENTAL

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

Interventions

E-cigarette OTHER

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.)

E-cigarette

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fordham University: lead
• Montefiore Medical Center: collaborator
• Dartmouth College: collaborator

Study Sites (1)

Montefiore Behavioral Health Center

The Bronx, New York, 10461, United States

RECRUITING

MeSH Terms

Conditions

Tobacco Smoking; Mental Disorders; Vaping; Smoking

Interventions

Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Haruka Minami, Ph.D.

  Fordham University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haruka Minami, Ph.D.

CONTACT

(718) 817-3885; hminami@fordham.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 10, 2019
• Study Start: December 12, 2020
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 18, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)