Cigarette Smoking
Conditions
Keywords
E-cigarettes, Harm reduction, Cigarette smoking, Serious mental illness
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 and lozenges to compare the efficacy in CC smoking reduction.
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.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Self-Reported Percent Change in CPD from Baseline to Week 12 | Baseline, Week 12 | Measured via self-report (daily diary about smoking behavior). |
| 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). |
| 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. |
| 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. |
| Self-Reported Percent Change in CPD from Baseline to Week 8 | Baseline, Week 8 | Measured via self-report (daily diary about smoking behavior). |
Countries
United States
Contacts
Primary ContactOmar El-Shahawy
Backup ContactIzamar Gallardo Castillo
Outcome results
None listed