Effectiveness and Impact of Counseling Enhanced Using Electronic Cigarettes for Harm Reduction in People With Serious Mental Illness
NYU Langone Health
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
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
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 th…
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.
Location
- NYU Langone HealthNew York, New York