Clinical trial NCT05815199: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cigarette Smoking
Keywords: E-cigarettes
Harm reduction
Cigarette smoking
Serious mental illness
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of Participants who Achieve a 100% Reduction in Cigarettes Per Day (CPD) by Week 4
timeFrame: Up to Week 4
measure: Percentage of Participants who Achieve a 100% Reduction in Cigarettes Per Day (CPD) by Week 8
timeFrame: Up to Week 8
Secondary outcomes:
measure: Percentage of Participants who Achieve a 100% Reduction in Cigarettes Per Day (CPD) by Week 12
timeFrame: Up to Week 12
measure: Self-Reported Percent Change in CPD from Baseline to Week 8
timeFrame: Baseline, Week 8
measure: Self-Reported Percent Change in CPD from Baseline to Week 12
timeFrame: Baseline, Week 12
measure: Change in American Thoracic Questionnaire Score from Baseline to Week 12
timeFrame: Baseline, Week 12
measure: Change in Symptom Check Questionnaire Score from Baseline to Week 12
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Omar El-Shahawy
role: PRINCIPAL_INVESTIGATOR
References: