Recruiting

E-Cigarettes

Sponsor:

NYU Langone Health

Code:

NCT05815199

Conditions

Cigarette Smoking

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

E-cigarette (EC)

Nicotine Replacement Therapy (NRT)

Harm-Reduction Counseling

Ecological Momentary Intervention (EMI) Text Messaging

Study Details

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 and lozenges to compare the efficacy in CC smoking reduction.

Conditions

Cigarette Smoking

Study ID

NCT05815199

Start date

Nov 13, 2023

Status verified date

Oct, 2025

Completion date

Mar, 2026

Anticipated

Primary completion date

Mar, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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.

Primary outcome measure

  • Percentage of Participants who Achieve a 100% Reduction in Cigarettes Per Day (CPD) by Week 4 [ Time Frame: Up to Week 4 ]
  • Percentage of Participants who Achieve a 100% Reduction in Cigarettes Per Day (CPD) by Week 8 [ Time Frame: Up to Week 8 ]

Central Contacts and Locations

Central contacts

Omar El-Shahawy

646-501-3587Omar.ElShahawy@nyulangone.org

Izamar Gallardo Castillo

646-501-3602Izamar.gallardocastillo@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Oct 10, 2025

Last verified

Oct, 2025

Keywords

  • E-cigarettes
  • Harm reduction
  • Cigarette smoking
  • Serious mental illness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2025-10-10.