Effectiveness and Impact of Counseling Enhanced Using Electronic Cigarettes for Harm Reduction in People With Serious Mental Illness

NCT05815199 NA RECRUITING

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.

Details

Lead sponsor	NYU Langone Health
Phase	NA
Status	RECRUITING
Enrolment	60
Start date	2023-11-13
Completion	2026-03

Conditions

• Cigarette Smoking

Interventions

• E-cigarette (EC)
• Nicotine Replacement Therapy (NRT)
• Harm-Reduction Counseling
• Ecological Momentary Intervention (EMI) Text Messaging

Primary outcomes

• 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).

Countries

United States