RecruitingNot ApplicableNCT05815199

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

Sponsor

NYU Langone Health

Enrollment

60 participants

Start Date

Nov 13, 2023

Study Type

INTERVENTIONAL

Conditions

Cigarette Smoking

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.

Eligibility

Min Age: 21 Years

Inclusion Criteria7

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 Criteria6

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

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Interventions

OTHERE-cigarette (EC)

Fixed dose. Participants are to use the EC as replacement for smoking combustible cigarettes. Participants will vape the EC.

OTHERNicotine Replacement Therapy (NRT)

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

BEHAVIORALHarm-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.

BEHAVIORALEcological 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.