Health TrialsbyHealthPanel

Harm Reduction for Smokers With Mental Illness

ConditionTobacco Dependence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorDartmouth-Hitchcock Medical Center

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Schizophrenia

Bipolar disorder

Major Depressive Disorders

Posttraumatic disorder

Disqualifiers

Currently residing in a nursing home;

Current diagnosis of Asthma;

Cognitive impairment (score <26 on the Telephone Interview for Cognitive Status (TICS);

Current use of e-cigarettes (>once a week);

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    Provision of e-cigarettes (NJOY) based on combusible use for the first 8 weeks of the study.

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: E-cigarette provision onlyActive comparator 1 intervention
Group B: SWITCH ITExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Urine NNAL

urine levels of NNAL

Time frame
baseline to 8 weeks, 8 weeks to 26 weeeks
2

Change in CO level

carbon monixide level less than 6

Time frame
baseline to 8 weeks, 8 weeks to 26 weeks
3

Change in self-reported cigarette use

self-report of combustible cigarette use

Time frame
baseline to 8 weeks 8 weeks to 16 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dartmouth-Hitchcock Medical Center

Lead sponsor

Dartmouth College

Collaborator

Fordham University

Collaborator

Seven Counties Services

Collaborator

Western Michigan University School of Medicine

Collaborator

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov
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