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Recruiting NCT06543407

NCT06543407 Harm Reduction for Smokers With Mental Illness

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Clinical Trial Summary
NCT ID NCT06543407
Status Recruiting
Phase
Sponsor Dartmouth-Hitchcock Medical Center
Condition Tobacco Dependence
Study Type INTERVENTIONAL
Enrollment 250 participants
Start Date 2024-10-01
Primary Completion 2027-12-31

Eligibility & Interventions

Sex All sexes
Min Age 21 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
SWITCH ITE-cig Provision Only

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 250 participants in total. It began in 2024-10-01 with a primary completion date of 2027-12-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

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

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.

Contact & Investigator

Central Contact

Meghan M. Santos, MSW

✉ meghan.m.santos@hitchcock.org

📞 978-494-4260

Principal Investigator

Sarah I. Pratt, PhD

PRINCIPAL INVESTIGATOR

Dartmouth Health

Frequently Asked Questions

Who can join the NCT06543407 clinical trial?

This trial is open to participants of all sexes, aged 21 Years or older, studying Tobacco Dependence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06543407 currently recruiting?

Yes, NCT06543407 is actively recruiting participants. Contact the research team at meghan.m.santos@hitchcock.org for enrollment information.

Where is the NCT06543407 trial being conducted?

This trial is being conducted at Louisville, United States, Providence, United States.

Who is sponsoring the NCT06543407 clinical trial?

NCT06543407 is sponsored by Dartmouth-Hitchcock Medical Center. The principal investigator is Sarah I. Pratt, PhD at Dartmouth Health. The trial plans to enroll 250 participants.

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