E-cigarettes for Harm Reduction Among Smokers With Serious Mental Illness

NYU Langone Health

Status: Enrolling

Conditions: Cigarette Smoking

Treatments: Behavioral: Harm-Reduction Counseling; Behavioral: Ecological Momentary Intervention (EMI) Text Messaging; Other: E-cigarette (EC); Other: Nicotine Replacement Therapy (NRT)

Study type: Interventional

Funder types: Other

Identifiers

NCT05815199

23-00124

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

E-cigarettes (EC)

Experimental group

Description:

Adult cigarette smokers with a SMI diagnosis randomized to the EC arm will receive NRT including nicotine patches and lozenges. Participants will also receive telehealth motivational counseling during the intervention period of 8 weeks.

Treatment:

Behavioral: Ecological Momentary Intervention (EMI) Text Messaging

Other: E-cigarette (EC)

Behavioral: Harm-Reduction Counseling

Nicotine Replacement Therapy (NRT)

Active Comparator group

Description:

Adult cigarette smokers with a SMI diagnosis randomized to the NRT arm will receive NRT including nicotine patches and lozenges gum. Participants will also receive telehealth motivational counseling during the intervention period of 8 weeks.

Treatment:

Other: Nicotine Replacement Therapy (NRT)

Behavioral: Ecological Momentary Intervention (EMI) Text Messaging

Behavioral: Harm-Reduction Counseling