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NCT Number: NCT06543407

Harm Reduction for Smokers With Mental Illness

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

Recruiting

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Key information

Conditions

Tobacco Dependence Behavior Chemically-Induced Disorders Harm Reduction Mental Disorders Smoking Substance-Related Disorders Tobacco Use Disorder Vaping

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seven Counties Services, Louisville, Kentucky, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in Urine NNAL

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

    urine levels of NNAL

  2. Change in CO level

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

    carbon monixide level less than 6

  3. Change in self-reported cigarette use

    Time frame: baseline to 8 weeks 8 weeks to 16 weeks

    self-report of combustible cigarette use

Study contacts

Contact information is provided by the study sponsor or research team.

Gail Williams, MS, MFT

CONTACT

[email protected]

Meghan M. Santos, MSW

CONTACT

[email protected]

978-494-4260

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • Dartmouth College
  • Fordham University
  • National Institute on Drug Abuse (NIDA)
  • Seven Counties Services
  • Western Michigan University School of Medicine

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Aug 9, 2024
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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