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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cigarette Smoking
• Intervention / Treatment: Other: E-cigarette (EC); Behavioral: Harm-Reduction Counseling; Behavioral: Ecological Momentary Intervention (EMI) Text Messaging; Other: Nicotine Replacement Therapy (NRT)

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Omar El-Shahawy; Phone Number: 646-501-3587; Email: Omar.ElShahawy@nyulangone.org
• Study Contact Backup: Name: Izamar Gallardo Castillo; Phone Number: 646-501-3602; Email: Izamar.gallardocastillo@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: E-cigarettes (EC); Adult cigarette smokers with a SMI diagnosis randomized to the EC arm will receive NRT including nicotine patches and lozenges. Participants will also receive telehealth motivational counseling during the intervention period of 8 weeks.	Other: E-cigarette (EC); Fixed dose. Participants are to use the EC as replacement for smoking combustible cigarettes. Participants will vape the EC.; Other Names: NJOY Ace or NJOY Daily Electronic Cigarette; 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.; Behavioral: 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.
Active Comparator: Nicotine Replacement Therapy (NRT); Adult cigarette smokers with a SMI diagnosis randomized to the NRT arm will receive NRT including nicotine patches and lozenges gum. Participants will also receive telehealth motivational counseling during the intervention period of 8 weeks.	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.; Behavioral: 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.; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Self-Reported Percent Change in CPD from Baseline to Week 8	Measured via self-report (daily diary about smoking behavior).	Baseline, Week 8
Self-Reported Percent Change in CPD from Baseline to Week 12	Measured via self-report (daily diary about smoking behavior).	Baseline, Week 12
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
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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Omar El-Shahawy, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: April 4, 2023
• First Submitted That Met QC Criteria: April 4, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Cigarette smoking; Harm reduction; Serious mental illness; E-cigarettes
• Additional Relevant MeSH Terms: Mental Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 23-00124

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No