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

Official title

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

Overview

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.

Interventions

• Other E-cigarette (EC)
  Fixed dose. Participants are to use the EC as replacement for smoking combustible cigarettes. Participants will vape the EC.
• 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.
• 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.

Primary outcome measures

• 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]

Secondary outcome measures (5)

• Percentage of Participants who Achieve a 100% Reduction in Cigarettes Per Day (CPD) by Week 12 [Time frame: Up to Week 12]
• Self-Reported Percent Change in CPD from Baseline to Week 8 [Time frame: Baseline, Week 8]
• Self-Reported Percent Change in CPD from Baseline to Week 12 [Time frame: Baseline, Week 12]
• Change in American Thoracic Questionnaire Score from Baseline to Week 12 [Time frame: Baseline, Week 12]
• Change in Symptom Check Questionnaire Score from Baseline to Week 12 [Time frame: Baseline, Week 12]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• NYU Langone Health — New York

Identifiers

NCT: NCT05815199 · 23-00124

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗