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

Primary Purpose

Tobacco Smoking, Psychiatric Disorders

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

E-cigarette

About this trial

This is an interventional other trial for Tobacco Smoking focused on measuring electronic cigarette use, smoking behavior

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Montefiore Behavioral Health CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

E-cigarette

Arm Description

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.

Outcomes

Primary Outcome Measures

Changes in the number of combustible cigarettes smoked per day

The average number of cigarettes smoked per day

Changes in Carbon Monoxide Level

Changes in Carbon monoxide level measured with a breath carbon monoxide monitor

Changes in Nicotine Dependence

Fagerstrom Test of Cigarette Dependence

Changes in the use of e-cigarettes

Rates of those who completely switched to e-cigarettes

Secondary Outcome Measures

Changes in Motivation/Readiness to Quit Smoking

Thoughts about Abstinence Scale & Contemplation Ladder

Changes in Withdrawal Symptoms

Minnesota Nicotine Withdrawal Scale

Full Information

NCT ID

NCT04014322

First Posted

July 8, 2019

Last Updated

September 15, 2023

Sponsor

Fordham University

Collaborators

Montefiore Medical Center, Dartmouth College

1. Study Identification

Unique Protocol Identification Number

NCT04014322

Brief Title

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

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 12, 2020 (Actual)

Primary Completion Date

September 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fordham University

Collaborators

Montefiore Medical Center, Dartmouth College

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tobacco Smoking, Psychiatric Disorders

Keywords

electronic cigarette use, smoking behavior

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

E-cigarette

Arm Type

Experimental

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

E-cigarette

Intervention Description

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 Information:

Title

Changes in the number of combustible cigarettes smoked per day

Description

The average number of cigarettes smoked per day

Time Frame

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

Title

Changes in Carbon Monoxide Level

Description

Changes in Carbon monoxide level measured with a breath carbon monoxide monitor

Time Frame

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

Title

Changes in Nicotine Dependence

Description

Fagerstrom Test of Cigarette Dependence

Time Frame

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

Title

Changes in the use of e-cigarettes

Description

Changes in the use of e-cigarettes

Time Frame

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

Title

Rates of those who completely switched to e-cigarettes

Description

Rates of those who completely switched to e-cigarettes

Time Frame

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

Secondary Outcome Measure Information:

Title

Changes in Motivation/Readiness to Quit Smoking

Description

Thoughts about Abstinence Scale & Contemplation Ladder

Time Frame

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

Title

Changes in Withdrawal Symptoms

Description

Minnesota Nicotine Withdrawal Scale

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Haruka Minami, Ph.D.

Phone

(718) 817-3885

hminami@fordham.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Haruka Minami, Ph.D.

Organizational Affiliation

Fordham University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Montefiore Behavioral Health Center

City

Bronx

State/Province

New York

ZIP/Postal Code

10461

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Haruka Minami, Ph.D.

Phone

718-817-3885

hminami@fordham.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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