Harm Reduction for Smokers With Mental Illness

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
Dartmouth-Hitchcock Medical Center
Study ID
NCT06543407
Status
Recruiting
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Conditions

  • Tobacco Dependence

Eligibility Criteria

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

Interventions

  • SWITCH IT — BEHAVIORAL
    Behavioral support for switching, 7-10 sessions with SWITCH IT coach delivered during the first 8 weeks of the study. SWITCH IT participants will also have the opportunity to receive supported "field trips" to explore e-cigarette options based on availability, cost, and preferences during week 4 and week 6.
  • E-cig Provision Only — OTHER
    Provision of e-cigarettes (NJOY) based on combusible use for the first 8 weeks of the study.

Study Details

To compare the efficacy of e-cigarette (e-cig) provision with or without behavioral support (SWITCH IT) delivered via telehealth to reduce harm among smokers with MI who cannot quit smoking and are not ready to pursue cessation treatment, and to examine self-regulation (using e-cigs instead of cigarettes to cope with stress/distress and self-efficacy) as a potential mechanism for behavior change from SWITCH IT

Key Dates

Start date
Oct 1, 2024
Status verified
Nov 2025
Primary completion
Dec 31, 2027
Completion
Mar 31, 2028

Study Design

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

Arms

  • Active Comparator: E-cigarette provision only
    Participants randomized to this condition will receive a supply of NJOY Daily e-cigarettes for the first 8 weeks of the study.
  • Experimental: SWITCH IT
    Participants randomized to this condition will receive a supply of e-cigarettes and behavioral support and coaching, protocolized intervention, SWITCH IT, for the first 8 weeks of the study.

Primary Outcome Measure

Change in Urine NNAL [ Time Frame: baseline to 8 weeks, 8 weeks to 26 weeeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Seven Counties ServicesLouisvilleKentucky40203
Cheri Green, EdD, MSN, RN
[email protected]
Dylan Hillerich, MEd
[email protected]
The Providence CenterProvidenceRhode Island02903
Diane Beckman, PhD
[email protected]
4012764020

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