Recruiting

Observational Study

Sponsor:

Fordham University

Code:

NCT04014322

Conditions

Tobacco Smoking

Psychiatric Disorders

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

E-cigarette

Study Details

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

Study ID

NCT04014322

Start date

Dec 12, 2020

Status verified date

Sep, 2023

Completion date

Dec, 2024

Anticipated

Primary completion date

Sep, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

Interventions

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.)

Primary outcome measure

  • Changes in the number of combustible cigarettes smoked per day [ Time Frame: Baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks ]
  • Changes in Carbon Monoxide Level [ Time Frame: Baseline,2 weeks, 4 weeks, 8 weeks, 12 weeks ]
  • Changes in Nicotine Dependence [ Time Frame: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks ]
  • Changes in the use of e-cigarettes [ Time Frame: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks ]
  • Rates of those who completely switched to e-cigarettes [ Time Frame: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks ]

Central Contacts and Locations

Central contacts

Haruka Minami, Ph.D.

(718) 817-3885hminami@fordham.edu

Locations

Montefiore Behavioral Health Center

Recruiting

Bronx, New York, United States, 10461

Contacts

Haruka Minami, Ph.D.

718-817-3885hminami@fordham.edu

More Information

Sponsor

Fordham University

Last update posted

Sep 18, 2023

Last verified

Sep, 2023

Keywords

  • electronic cigarette use
  • smoking behavior

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Fordham University on 2023-09-18.