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
Qualifiers
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
Treatments tested in this trial
- E-cigarette (EC)
- Nicotine Replacement Therapy (NRT)
- Harm-Reduction Counseling
- Ecological Momentary Intervention (EMI) Text Messaging
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov