Tobacco SmokingNCT04014322
The Effect of Electronic Cigarette Use on Smoking Behaviors Among Smokers Receiving Outpatient Psychiatric Treatment
A study testing E-cigarette in people with Tobacco Smoking and Psychiatric Disorders, run by Fordham University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Tobacco Smoking, Psychiatric Disorders
- What is being tested?
- E-cigarette
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2020to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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),
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- 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.
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Montefiore Behavioral Health Center
The Bronx, New York, 10461
Haruka Minami, Ph.D., 718-817-3885, hminami@fordham.edu
About this study
Official title: 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.
Read the 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).
- Conditions
- Tobacco Smoking, Psychiatric Disorders
- Being tested
- E-cigarette
- Keywords
- electronic cigarette use, smoking behavior
- Medical subject headings
- Tobacco Smoking, Mental Disorders, Vaping, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-cigaretteOther
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.)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: E-cigarette |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the number of combustible cigarettes smoked per day
The average number of cigarettes smoked per day
Measured: 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
Measured: Baseline,2 weeks, 4 weeks, 8 weeks, 12 weeks
Changes in Nicotine Dependence
Fagerstrom Test of Cigarette Dependence
Measured: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks
Changes in the use of e-cigarettes
Changes in the use of e-cigarettes
Measured: 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
Measured: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks
Secondary outcomes (2)
Changes in Motivation/Readiness to Quit Smoking
Thoughts about Abstinence Scale \& Contemplation Ladder
Measured: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks
Changes in Withdrawal Symptoms
Minnesota Nicotine Withdrawal Scale
Measured: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start12 Dec 2020
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fordham University
- Sponsor type
- University, hospital or other
- Collaborators
- Montefiore Medical Center, Dartmouth College
- Responsible party
- Sponsor
- Investigators
- Haruka Minami, Ph.D., Principal investigator, Fordham University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04014322
- Sponsor's protocol ID
- 1089
- Status last verified
- Sep 2023
- First submitted
- 8 Jul 2019
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Electronic Cigarette Use on Smoking Behaviors and Smoking-related Factors Among Smokers Receiving Outpatient Psychiatric Treatment
- ClinicalTrials.gov ID
- NCT04014322
- Acronym / sponsor ID
- 1089
- Conditions
- Tobacco Smoking, Psychiatric Disorders
- Keywords
- electronic cigarette use, smoking behavior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fordham UniversityUniversity, hospital or other
- Collaborators
- Montefiore Medical Center, Dartmouth College
- Study start
- 12 Dec 2020 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 10 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| E-cigarette | Experimental | Other: E-cigaretteAll 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-cigaretteAll 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.) | Other | E-cigarette |
Primary outcome
Changes in the number of combustible cigarettes smoked per day
Time frame: Baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks
The average number of cigarettes smoked per day
Changes in Carbon Monoxide Level
Time frame: Baseline,2 weeks, 4 weeks, 8 weeks, 12 weeks
Changes in Carbon monoxide level measured with a breath carbon monoxide monitor
Changes in Nicotine Dependence
Time frame: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks
Fagerstrom Test of Cigarette Dependence
Changes in the use of e-cigarettes
Time frame: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks
Changes in the use of e-cigarettes
Rates of those who completely switched to e-cigarettes
Time frame: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks
Rates of those who completely switched to e-cigarettes
2 secondary outcomes
Changes in Motivation/Readiness to Quit Smoking
Time frame: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks
Changes in Withdrawal Symptoms
Time frame: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haruka Minami, Ph.D. principal investigator
Fordham University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-cigarette in people with Tobacco Smoking and Psychiatric Disorders, run by Fordham University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haruka Minami, Ph.D. ((718) 817-3885, hminami@fordham.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023.