Clinical trial NCT04014322: The Effect of Electronic Cigarette Use on Smoking Behaviors Among Smokers Receiving Outpatient Psychiatric Treatment
Official title: The Effect of Electronic Cigarette Use on Smoking Behaviors and Smoking-related Factors Among Smokers Receiving Outpatient Psychiatric Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tobacco Smoking
Psychiatric Disorders
Keywords: electronic cigarette use
smoking behavior
Lead sponsor: Fordham University
Sponsor class: OTHER
Collaborators: name: Montefiore Medical Center
name: Dartmouth College
First posted: 2019-07-10
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Changes in the number of combustible cigarettes smoked per day
timeFrame: Baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks
measure: Changes in Carbon Monoxide Level
timeFrame: Baseline,2 weeks, 4 weeks, 8 weeks, 12 weeks
measure: Changes in Nicotine Dependence
timeFrame: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks
measure: Changes in the use of e-cigarettes
timeFrame: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks
measure: Rates of those who completely switched to e-cigarettes
timeFrame: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks
Secondary outcomes:
measure: Changes in Motivation/Readiness to Quit Smoking
timeFrame: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks
measure: Changes in Withdrawal Symptoms
timeFrame: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Behavioral Health Center
state: New York
Study officials:
affiliation: Fordham University
name: Haruka Minami, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: