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Recruiting NCT06543407

Harm Reduction for Smokers With Mental Illness

No phase Interventional Tobacco Dependence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SWITCH IT, E-cig Provision Only.
Who it may be relevant to
Registry conditions: Tobacco Dependence. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Harm Reduction for Smokers With Mental Illness: RCT of E-cigarette Provision With or Without Behavioral Support to Boost Switching

Overview

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

Interventions

  • Behavioral SWITCH IT
    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.
  • Other E-cig Provision Only
    Provision of e-cigarettes (NJOY) based on combusible use for the first 8 weeks of the study.

Primary outcome measures

  • Change in Urine NNAL [Time frame: baseline to 8 weeks, 8 weeks to 26 weeeks]
  • Change in CO level [Time frame: baseline to 8 weeks, 8 weeks to 26 weeks]
  • Change in self-reported cigarette use [Time frame: baseline to 8 weeks 8 weeks to 16 weeks]

Eligibility criteria

Diagnostic Criteria (must have one to be eligible):

  • Schizophrenia
  • Bipolar disorder
  • Major Depressive Disorders
  • Posttraumatic disorder
  • Other anxiety disorders

Additional Inclusion Criteria:

  • 21 years or older;
  • English-speaking;
  • Daily smoker (at least 10 cigarettes/day);
  • At least one quit attempt in the past 5 years using evidence- based pharmacotherapy or behavioral cessation support;
  • Not currently interested in quitting.

Exclusion criteria

  • 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);
  • Psychiatric instability (hospitalized in the past month);
  • Current AND moderate to severe substance use disorder;
  • Pregnant or planning to become pregnant;
  • Use of any smoked products other than cigarettes;
  • Current unstable medical illness making e-cigarette unsafe (e.g., recent heart attack, cancer);
  • Participation in SWITCH IT pilot study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Seven Counties Services — Louisville
  • The Providence Center — Providence

Identifiers

NCT: NCT06543407 · 02002328 · R01DA057729-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗