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

Not Applicable

Recruiting

• Conditions: Cigarette Smoking
• Interventions: Other: E-cigarette (EC); Other: Nicotine Replacement Therapy (NRT); Behavioral: Harm-Reduction Counseling; Behavioral: Ecological Momentary Intervention (EMI) Text Messaging

• Registration Number: NCT05815199
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-04
• Study First Submitted QC: 2023-04-04
• Study First Posted: 2023-04-18
• Study Start: 2023-11-13
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-10
• Last Update Posted: 2024-10-14
• Primary Completion: 2025-06
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
E-cigarettes (EC)	E-cigarette (EC)	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.
Nicotine Replacement Therapy (NRT)	Nicotine Replacement Therapy (NRT)	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.
Nicotine Replacement Therapy (NRT)	Ecological Momentary Intervention (EMI) Text Messaging	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.
E-cigarettes (EC)	Ecological Momentary Intervention (EMI) Text Messaging	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.
Nicotine Replacement Therapy (NRT)	Harm-Reduction Counseling	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.
E-cigarettes (EC)	Harm-Reduction Counseling	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Self-Reported Percent Change in CPD from Baseline to Week 8	Baseline, Week 8	Measured via self-report (daily diary about smoking behavior).
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 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.
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.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States