E-cigarettes for Harm Reduction Among Smokers With Serious Mental Illness
ConditionCigarette Smoking
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorNYU Langone Health
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
E-cigarette (EC)
Other interventionFixed dose. Participants are to use the EC as replacement for smoking combustible cigarettes. Participants will vape the EC.
Nicotine Replacement Therapy (NRT)
Other interventionIncludes nicotine patches and lozenges. NRT use recommendations will follow the guidelines of the product, e.g. one patch per day.
Harm-Reduction Counseling
BehavioralAt 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.
Ecological Momentary Intervention (EMI) Text Messaging
BehavioralEMI 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: E-cigarettes (EC)Experimental treatment 3 interventions
Group B: Nicotine Replacement Therapy (NRT)Active comparator 3 interventions
Trial outcomes
Primary outcomes
1
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).
Time frame
Up to Week 42
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).
Time frame
Up to Week 8Secondary outcomes
1
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).
Time frame
Up to Week 122
Self-Reported Percent Change in CPD from Baseline to Week 8
Measured via self-report (daily diary about smoking behavior).
Time frame
Baseline, Week 83
Self-Reported Percent Change in CPD from Baseline to Week 12
Measured via self-report (daily diary about smoking behavior).
Time frame
Baseline, Week 124
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.
Time frame
Baseline, Week 12Sponsors and contacts
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Source ClinicalTrials.gov