E-cigarettes for Harm Reduction Among Smokers With Serious Mental Illness
Study Details
Study Description
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, lozenges and gums to compare the efficacy in CC smoking reduction.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: E-cigarettes (EC) 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)
Fixed dose. Participants are to use the EC as replacement for smoking combustible cigarettes. Participants will vape the EC.
Other Names:
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.
|
| Active Comparator: Nicotine Replacement Therapy (NRT) 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)
Includes nicotine patches, lozenges and gum. 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.
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants who Achieve a 100% Reduction in Cigarettes Per Day (CPD) by Week 4 [Up to Week 4]
Measured via self-report (daily diary about smoking behavior) and verified by exhaled carbon-monoxide (eCO) level (< 6 ppm).
- Percentage of Participants who Achieve a 100% Reduction in Cigarettes Per Day (CPD) by Week 8 [Up to Week 8]
Measured via self-report (daily diary about smoking behavior) and verified by exhaled carbon-monoxide (eCO) level (< 6 ppm).
Secondary Outcome Measures
- Percentage of Participants who Achieve a 100% Reduction in Cigarettes Per Day (CPD) by Week 12 [Up to Week 12]
Measured via self-report (daily diary about smoking behavior) and verified by exhaled carbon-monoxide (eCO) level (< 6 ppm).
- Self-Reported Percent Change in CPD from Baseline to Week 8 [Baseline, Week 8]
Measured via self-report (daily diary about smoking behavior).
- Self-Reported Percent Change in CPD from Baseline to Week 12 [Baseline, Week 12]
Measured via self-report (daily diary about smoking behavior).
- Change in American Thoracic Questionnaire Score from Baseline to Week 12 [Baseline, 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.
- Change in Symptom Check Questionnaire Score from Baseline to Week 12 [Baseline, 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Currently smokes 5 or more CPD
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Willingness and ability to provide informed consent
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Age of at least 21 years
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Has SMI diagnosis (such as Schizophrenia, Schizoaffective disorders, Bipolar disorder, Depressive disorders, Trauma and stressor related disorders etc.) as determined using the MINI tool
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Interested in reducing CC smoking but not necessarily trying to quit
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Own a mobile phone or have regular access to a mobile phone
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Able to provide an additional contact to improve follow-up rates
Exclusion Criteria:
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Is pregnant or breastfeeding
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Used tobacco other than CC in the past 2 weeks (e.g., EC, cigarillo)
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Currently engaged in an attempt to quit CC
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Change in dose of their psychotropic medication(s) in the last 30 days
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Meeting DSM-V criteria for current alcohol or substance use disorder except for nicotine use disorder and active mild alcohol or substance use disorders.
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Past month suicidal ideation/suicide attempt and/or psychiatric hospitalization in the last 30 days
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | NYU Langone Health | New York | New York | United States | 10016 |
Sponsors and Collaborators
- NYU Langone Health
Investigators
- Principal Investigator: Omar El-Shahawy, NYU Langone Health
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 23-00124