E-cigarettes for Harm Reduction Among Smokers With Serious Mental Illness

Cigarette Smoking Clinical Trial

Official title:

Effectiveness and Impact of Counseling Enhanced Using Electronic Cigarettes for Harm Reduction in People With Serious Mental Illness

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05815199
• Other study ID #: 23-00124
• Status: Recruiting
• Phase: N/A
• Start date: November 13, 2023
• Est. completion date: August 2024

Study information

• Verified date: January 2024
• Source: NYU Langone Health
• Contact: Omar El-Shahawy
• Phone: 646-501-3587
• Email: Omar.ElShahawy[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 and lozenges to compare the efficacy in CC smoking reduction.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cigarette Smoking
• Mental Disorders

Intervention

Other:
• E-cigarette (EC)
Fixed dose. Participants are to use the EC as replacement for smoking combustible cigarettes. Participants will vape the EC.
• Nicotine Replacement Therapy (NRT)
Includes nicotine patches and lozenges. NRT use recommendations will follow the guidelines of the product, e.g. one patch per day.

Behavioral:
• Harm-Reduction Counseling
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.
• Ecological Momentary Intervention (EMI) Text Messaging
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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Up to Week 4
Primary	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).	Up to Week 8
Secondary	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).	Up to Week 12
Secondary	Self-Reported Percent Change in CPD from Baseline to Week 8	Measured via self-report (daily diary about smoking behavior).	Baseline, Week 8
Secondary	Self-Reported Percent Change in CPD from Baseline to Week 12	Measured via self-report (daily diary about smoking behavior).	Baseline, Week 12
Secondary	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.	Baseline, Week 12
Secondary	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.	Baseline, Week 12