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

StatusRecruiting
PhaseNot applicable
Started2023-11-13
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Mar 2026 → Mar 2027
See other at-risk trials from NYU Langone Health

Amendment history

2026-09-30
Primary completion pushed: 2026-03 → 2027-03
Completion pushed: 2026-03 → 2027-03
2025-10-08
Study Status v6
Primary completion date2025-06→2026-03
Completion date2025-08→2026-03
2024-10-10
Study Status v5
Primary completion date2024-06→2025-06
Completion date2024-08→2025-08
2024-01-29
Not Yet Recruiting→Recruiting Study Status, Study Description, Arms and Interventions, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2023-12→2024-06
Completion date2024-03→2024-08
Start dateestimated 2023-11→confirmed 2023-11-13
Study sitesdetails revised at 1 of 1 site
2023-11-06
Study Status v3
Start date2023-09→2023-11
Show 2 earlier versions
2023-08-22
Study Status v2
Start date2023-07→2023-09
2023-06-26
Study Status v1
Start date2023-04→2023-07
2023-04-04
Original filing
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.
Trial Details
NCT Number NCT05815199
Lead Sponsor NYU Langone Health
Conditions Cigarette Smoking
Enrollment 60 participants
Start Date 2023-11-13
Primary Completion 2027-03 (estimated)
Study Completion 2027-03 (estimated)
Updated on ClinicalTrials.gov 2026-09-29