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

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT05815199
Status
Recruiting
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Conditions

  • Cigarette Smoking

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • E-cigarette (EC) — OTHER
    Fixed dose. Participants are to use the EC as replacement for smoking combustible cigarettes. Participants will vape the EC.
  • Nicotine Replacement Therapy (NRT) — OTHER
    Includes nicotine patches and lozenges. NRT use recommendations will follow the guidelines of the product, e.g. one patch per day.
  • Harm-Reduction Counseling — BEHAVIORAL
    At baseline, after randomization, participants will receive their first telehealth session (20\~25 minutes) from a counselor trained in motivational interviewing, harm reduction, and smoking cessation. Up to five additional sessions will be delivered, 15\~20 minutes each.
  • Ecological Momentary Intervention (EMI) Text Messaging — BEHAVIORAL
    EMI can be defined as delivering tailored interventions via electronic messages (i.e., regular text messages) that include personalized feedback based on real-time assessment responses and other contextual factors. EMI will take place throughout the intervention period.

Study Details

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.

Key Dates

Start date
Nov 13, 2023
Status verified
Oct 2025
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: E-cigarettes (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.
  • Active Comparator: 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.

Primary Outcome Measure

Percentage of Participants who Achieve a 100% Reduction in Cigarettes Per Day (CPD) by Week 4 [ Time Frame: Up to Week 4 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

Find similar trials in New York, NY

By research site
NYU Langone Health· New York, NY

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