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NCT Number: NCT05815199

E-cigarettes for Harm Reduction Among Smokers 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.

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Key information

Conditions

Cigarette Smoking Behavior Harm Reduction Smoking Tobacco Smoking Tobacco Use Vaping

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

E-Cigarette (EC)

Other

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

Nicotine replacement therapy (NRT)

Other

Includes nicotine patches and lozenges. NRT use recommendations will follow the guidelines of the product, e.g. one patch per day.

Harm-Reduction Counseling

Behavioral

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

Behavioral

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 outcomes

  1. Percentage of Participants who Achieve a 100% Reduction in Cigarettes Per Day (CPD) by Week 4

    Time frame: Up to Week 4

    Measured via self-report (daily diary about smoking behavior) and verified by exhaled carbon-monoxide (eCO) level (< 6 ppm).

  2. Percentage of Participants who Achieve a 100% Reduction in Cigarettes Per Day (CPD) by Week 8

    Time frame: Up to Week 8

    Measured via self-report (daily diary about smoking behavior) and verified by exhaled carbon-monoxide (eCO) level (< 6 ppm).

Secondary outcomes

  1. Percentage of Participants who Achieve a 100% Reduction in Cigarettes Per Day (CPD) by Week 12

    Time frame: Up to Week 12

    Measured via self-report (daily diary about smoking behavior) and verified by exhaled carbon-monoxide (eCO) level (< 6 ppm).

  2. Self-Reported Percent Change in CPD from Baseline to Week 8

    Time frame: Baseline, Week 8

    Measured via self-report (daily diary about smoking behavior).

  3. Self-Reported Percent Change in CPD from Baseline to Week 12

    Time frame: Baseline, Week 12

    Measured via self-report (daily diary about smoking behavior).

  4. Change in American Thoracic Questionnaire Score from Baseline to Week 12

    Time frame: Baseline, 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.

  5. Change in Symptom Check Questionnaire Score from Baseline to Week 12

    Time frame: Baseline, 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Izamar Gallardo Castillo

CONTACT

[email protected]

646-501-3602

Omar El-Shahawy

CONTACT

[email protected]

646-501-3587

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 18, 2023
Registry last updated
Oct 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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