Back to resultsE-cigarettes for Harm Reduction Among Smokers With Serious Mental Illness
Primary Purpose
Cigarette Smoking
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
E-cigarette (EC)
Nicotine Replacement Therapy (NRT)
Harm-Reduction Counseling
Ecological Momentary Intervention (EMI) Text Messaging
Sponsored by
About this trial
This is an interventional treatment trial for Cigarette Smoking focused on measuring E-cigarettes, Harm reduction, Cigarette smoking, Serious mental illness
Eligibility Criteria
Inclusion Criteria: Currently smokes 5 or more CPD Willingness and ability to provide informed consent Age of at least 21 years Has SMI diagnosis (such as Schizophrenia, Schizoaffective disorders, Bipolar disorder, Depressive disorders, Trauma and stressor related disorders etc.) as determined using the MINI tool Interested in reducing CC smoking but not necessarily trying to quit Own a mobile phone or have regular access to a mobile phone Able to provide an additional contact to improve follow-up rates Exclusion Criteria: Is pregnant or breastfeeding Used tobacco other than CC in the past 2 weeks (e.g., EC, cigarillo) Currently engaged in an attempt to quit CC Change in dose of their psychotropic medication(s) in the last 30 days Meeting DSM-V criteria for current alcohol or substance use disorder except for nicotine use disorder and active mild alcohol or substance use disorders. Past month suicidal ideation/suicide attempt and/or psychiatric hospitalization in the last 30 days
Sites / Locations
- NYU Langone Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
E-cigarettes (EC)
Nicotine Replacement Therapy (NRT)
Arm Description
Adult cigarette smokers with a SMI diagnosis randomized to the EC arm will receive NRT including nicotine patches, lozenges and gum. Participants will also receive telehealth motivational counseling during the intervention period of 8 weeks.
Adult cigarette smokers with a SMI diagnosis randomized to the NRT arm will receive NRT including nicotine patches, lozenges and gum. Participants will also receive telehealth motivational counseling during the intervention period of 8 weeks.
Outcomes
Primary Outcome Measures
Percentage of Participants who Achieve a 100% Reduction in Cigarettes Per Day (CPD) by Week 4
Measured via self-report (daily diary about smoking behavior) and verified by exhaled carbon-monoxide (eCO) level (< 6 ppm).
Percentage of Participants who Achieve a 100% Reduction in Cigarettes Per Day (CPD) by Week 8
Measured via self-report (daily diary about smoking behavior) and verified by exhaled carbon-monoxide (eCO) level (< 6 ppm).
Secondary Outcome Measures
Percentage of Participants who Achieve a 100% Reduction in Cigarettes Per Day (CPD) by Week 12
Measured via self-report (daily diary about smoking behavior) and verified by exhaled carbon-monoxide (eCO) level (< 6 ppm).
Self-Reported Percent Change in CPD from Baseline to Week 8
Measured via self-report (daily diary about smoking behavior).
Self-Reported Percent Change in CPD from Baseline to Week 12
Measured via self-report (daily diary about smoking behavior).
Change in American Thoracic Questionnaire Score from Baseline to Week 12
8-item questionnaire assessing general thoracic pain. Items are rated on a Likert scale from 1 (never) to 5 (every day). The total score is the sum of responses and ranges from 8-40; higher scores indicate more severe impact of general thoracic pain.
Change in Symptom Check Questionnaire Score from Baseline to Week 12
9-item assessment of chronic obstructive pulmonary disease (COPD) symptoms. Each item is marked as either "yes" or "no." The total score is the number of "yes" responses and ranges from 0-9; higher scores indicate more severe COPD symptoms.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05815199
Brief Title
E-cigarettes for Harm Reduction Among Smokers With Serious Mental Illness
Official Title
Effectiveness and Impact of Counseling Enhanced Using Electronic Cigarettes for Harm Reduction in People With Serious Mental Illness
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this open-label, randomized controlled trial study, participants who smoke combustible cigarettes (CC) and are diagnosed with Serious Mental Illness (SMI) will be randomized in two arms to receive harm-reduction counseling and Ecological Momentary Intervention text messaging (EMI) along with either e-cigarettes (EC) or nicotine replacement therapy (NRT) such as patch, lozenges and gums to compare the efficacy in CC smoking reduction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cigarette Smoking
Keywords
E-cigarettes, Harm reduction, Cigarette smoking, Serious mental illness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
E-cigarettes (EC)
Arm Type
Experimental
Arm Description
Adult cigarette smokers with a SMI diagnosis randomized to the EC arm will receive NRT including nicotine patches, lozenges and gum. Participants will also receive telehealth motivational counseling during the intervention period of 8 weeks.
Arm Title
Nicotine Replacement Therapy (NRT)
Arm Type
Active Comparator
Arm Description
Adult cigarette smokers with a SMI diagnosis randomized to the NRT arm will receive NRT including nicotine patches, lozenges and gum. Participants will also receive telehealth motivational counseling during the intervention period of 8 weeks.
Intervention Type
Other
Intervention Name(s)
E-cigarette (EC)
Other Intervention Name(s)
NJOY Ace Electronic Cigarette
Intervention Description
Fixed dose. Participants are to use the EC as replacement for smoking combustible cigarettes. Participants will vape the EC.
Intervention Type
Other
Intervention Name(s)
Nicotine Replacement Therapy (NRT)
Intervention Description
Includes nicotine patches, lozenges and gum. NRT use recommendations will follow the guidelines of the product, e.g. one patch per day.
Intervention Type
Behavioral
Intervention Name(s)
Harm-Reduction Counseling
Intervention Description
At baseline, after randomization, participants will receive their first telehealth session (20~25 minutes) from a counselor trained in motivational interviewing, harm reduction, and smoking cessation. Up to five additional sessions will be delivered, 15~20 minutes each.
Intervention Type
Behavioral
Intervention Name(s)
Ecological Momentary Intervention (EMI) Text Messaging
Intervention Description
EMI can be defined as delivering tailored interventions via electronic messages (i.e., regular text messages) that include personalized feedback based on real-time assessment responses and other contextual factors. EMI will take place throughout the intervention period.
Primary Outcome Measure Information:
Title
Percentage of Participants who Achieve a 100% Reduction in Cigarettes Per Day (CPD) by Week 4
Description
Measured via self-report (daily diary about smoking behavior) and verified by exhaled carbon-monoxide (eCO) level (< 6 ppm).
Time Frame
Up to Week 4
Title
Percentage of Participants who Achieve a 100% Reduction in Cigarettes Per Day (CPD) by Week 8
Description
Measured via self-report (daily diary about smoking behavior) and verified by exhaled carbon-monoxide (eCO) level (< 6 ppm).
Time Frame
Up to Week 8
Secondary Outcome Measure Information:
Title
Percentage of Participants who Achieve a 100% Reduction in Cigarettes Per Day (CPD) by Week 12
Description
Measured via self-report (daily diary about smoking behavior) and verified by exhaled carbon-monoxide (eCO) level (< 6 ppm).
Time Frame
Up to Week 12
Title
Self-Reported Percent Change in CPD from Baseline to Week 8
Description
Measured via self-report (daily diary about smoking behavior).
Time Frame
Baseline, Week 8
Title
Self-Reported Percent Change in CPD from Baseline to Week 12
Description
Measured via self-report (daily diary about smoking behavior).
Time Frame
Baseline, Week 12
Title
Change in American Thoracic Questionnaire Score from Baseline to Week 12
Description
8-item questionnaire assessing general thoracic pain. Items are rated on a Likert scale from 1 (never) to 5 (every day). The total score is the sum of responses and ranges from 8-40; higher scores indicate more severe impact of general thoracic pain.
Time Frame
Baseline, Week 12
Title
Change in Symptom Check Questionnaire Score from Baseline to Week 12
Description
9-item assessment of chronic obstructive pulmonary disease (COPD) symptoms. Each item is marked as either "yes" or "no." The total score is the number of "yes" responses and ranges from 0-9; higher scores indicate more severe COPD symptoms.
Time Frame
Baseline, Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Currently smokes 5 or more CPD
Willingness and ability to provide informed consent
Age of at least 21 years
Has SMI diagnosis (such as Schizophrenia, Schizoaffective disorders, Bipolar disorder, Depressive disorders, Trauma and stressor related disorders etc.) as determined using the MINI tool
Interested in reducing CC smoking but not necessarily trying to quit
Own a mobile phone or have regular access to a mobile phone
Able to provide an additional contact to improve follow-up rates
Exclusion Criteria:
Is pregnant or breastfeeding
Used tobacco other than CC in the past 2 weeks (e.g., EC, cigarillo)
Currently engaged in an attempt to quit CC
Change in dose of their psychotropic medication(s) in the last 30 days
Meeting DSM-V criteria for current alcohol or substance use disorder except for nicotine use disorder and active mild alcohol or substance use disorders.
Past month suicidal ideation/suicide attempt and/or psychiatric hospitalization in the last 30 days
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Omar El-Shahawy
Phone
646-501-3587
Email
Omar.ElShahawy@nyulangone.org
First Name & Middle Initial & Last Name or Official Title & Degree
Adetayo Fawole
Phone
646-501-3568
Email
Adetayo.fawole@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omar El-Shahawy
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request or for individual participant data meta-analysis beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data or researcher who provides a methodologically sound proposal executes a data use agreement with NYU Langone Health. Requests may be directed to: Omar.ElShahawy@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
The investigator who proposed to use the data or researchers who provide a methodologically sound proposal will be granted access upon reasonable request or for individual participant data meta-analysis. Requests should be directed to Omar.ElShahawy@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
Learn more about this trial
E-cigarettes for Harm Reduction Among Smokers With Serious Mental Illness
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