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

Study Overview
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Brief Summary
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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, lozenges and gums to compare the efficacy in CC smoking reduction.

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

Conditions
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Cigarette Smoking

Intervention / Treatment
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* Other: E-cigarette (EC)
* Other: Nicotine Replacement Therapy (NRT)
* Behavioral: Harm-Reduction Counseling
* Behavioral: Ecological Momentary Intervention (EMI) Text Messaging


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E-cigarettes (EC)<br>Adult cigarette smokers with a SMI diagnosis randomized to the EC arm will receive NRT including nicotine patches, lozenges and gum. Participants will also receive telehealth motivational counseling during the intervention period of 8 weeks. | Other: E-cigarette (EC)<br>* Fixed dose. Participants are to use the EC as replacement for smoking combustible cigarettes. Participants will vape the EC.<br>* Other names: NJOY Ace Electronic Cigarette;Behavioral: Harm-Reduction Counseling<br>* 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.<br>Behavioral: Ecological Momentary Intervention (EMI) Text Messaging<br>* 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.<br>|
| Active Comparator: Nicotine Replacement Therapy (NRT)<br>Adult cigarette smokers with a SMI diagnosis randomized to the NRT arm will receive NRT including nicotine patches, lozenges and gum. Participants will also receive telehealth motivational counseling during the intervention period of 8 weeks. | Other: Nicotine Replacement Therapy (NRT)<br>* Includes nicotine patches, lozenges and gum. NRT use recommendations will follow the guidelines of the product, e.g. one patch per day.<br>Behavioral: Harm-Reduction Counseling<br>* 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.<br>Behavioral: Ecological Momentary Intervention (EMI) Text Messaging<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants who Achieve a 100% Reduction in Cigarettes Per Day (CPD) by Week 4 | Measured via self-report (daily diary about smoking behavior) and verified by exhaled carbon-monoxide (eCO) level (< 6 ppm). | Up to Week 4 | 
| Percentage of Participants who Achieve a 100% Reduction in Cigarettes Per Day (CPD) by Week 8 | Measured via self-report (daily diary about smoking behavior) and verified by exhaled carbon-monoxide (eCO) level (< 6 ppm). | Up to Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants who Achieve a 100% Reduction in Cigarettes Per Day (CPD) by Week 12 | Measured via self-report (daily diary about smoking behavior) and verified by exhaled carbon-monoxide (eCO) level (< 6 ppm). | Up to Week 12 | 
| Self-Reported Percent Change in CPD from Baseline to Week 8 | Measured via self-report (daily diary about smoking behavior). | Baseline, Week 8 | 
| Self-Reported Percent Change in CPD from Baseline to Week 12 | Measured via self-report (daily diary about smoking behavior). | Baseline, Week 12 | 
| Change in American Thoracic Questionnaire Score from Baseline to 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. | Baseline, Week 12 | 
| Change in Symptom Check Questionnaire Score from Baseline to 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. | Baseline, Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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E-cigarettes, Harm reduction, Cigarette smoking, Serious mental illness