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.
Brief Title
The Effect of Electronic Cigarette Use on Smoking Behaviors Among Smokers Receiving Outpatient Psychiatric Treatment
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).
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).
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
(718) 817-3885
Central Contact Email
hminami@fordham.edu
Completion Date
Completion Date Type
Estimated
Conditions
Tobacco Smoking
Psychiatric Disorders
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
* 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
Inclusion 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.
* 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.
Gender
All
Gender Based
false
Keywords
electronic cigarette use
smoking behavior
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
21 Years
NCT Id
NCT04014322
Org Class
Other
Org Full Name
Fordham University
Org Study Id
1089
Overall Status
Recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
The Effect of Electronic Cigarette Use on Smoking Behaviors and Smoking-related Factors Among Smokers Receiving Outpatient Psychiatric Treatment
Primary Outcomes
Outcome Description
The average number of cigarettes smoked per day
Outcome Measure
Changes in the number of combustible cigarettes smoked per day
Outcome Time Frame
Baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks
Outcome Description
Changes in Carbon monoxide level measured with a breath carbon monoxide monitor
Outcome Measure
Changes in Carbon Monoxide Level
Outcome Time Frame
Baseline,2 weeks, 4 weeks, 8 weeks, 12 weeks
Outcome Description
Fagerstrom Test of Cigarette Dependence
Outcome Measure
Changes in Nicotine Dependence
Outcome Time Frame
Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks
Outcome Description
Changes in the use of e-cigarettes
Outcome Measure
Changes in the use of e-cigarettes
Outcome Time Frame
Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks
Outcome Description
Rates of those who completely switched to e-cigarettes
Outcome Measure
Rates of those who completely switched to e-cigarettes
Outcome Time Frame
Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks
Secondary Outcomes
Outcome Description
Thoughts about Abstinence Scale \& Contemplation Ladder
Outcome Time Frame
Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks
Outcome Measure
Changes in Motivation/Readiness to Quit Smoking
Outcome Description
Minnesota Nicotine Withdrawal Scale
Outcome Time Frame
Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks
Outcome Measure
Changes in Withdrawal Symptoms
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
21
Investigators
Investigator Type
Principal Investigator
Investigator Name
Shadi Nahvi
Investigator Email
snahvi@montefiore.org