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The Appeal and Impact of E-cigarettes in Smokers With SMI
NCT03050853 · View on ClinicalTrials.gov ↗
Study Summary
This study will evaluate behavioral and psychological appeal, toxicity, and effect of e-cigarettes on smoking behavior and nicotine addiction in chronic smokers with serious mental illness (SMI) who have failed to quit smoking. A total of 240 participants will be enrolled and randomly assigned to either receive a supply of e-cigarettes for 8 weeks plus assessments (baseline \& weeks 2, 4, 6, 8, 13, \& 26) or assessments only. This single-blinded study will provide e-cigarettes and instructions on their safe use. Level of appeal will be inferred from carefully assessed use of e-cigarettes and reduction in combustible tobacco. Qualitative data will also be collected from participants assigned to e-cigarettes, given that unanticipated issues will almost certainly arise in connection with e-cigarette use that can only be captured within a qualitative debriefing at the conclusion of participants' time in the study.
Conditions Studied
Interventions
- BEHAVIORAL E-cigarette
Study Locations (2)
Kentucky
- Centerstone Kentucky — Louisville
Massachusetts
- Vinfen Corp — Lawrence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2017-03-01 |
| Est. Completion | 2021-01-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03050853
The ClinicalTrials.gov registry entry for NCT03050853 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dartmouth-Hitchcock Medical Center, which has 396 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Schizophrenia appearing as the primary indexed condition, and to 1 intervention — of which E-cigarette is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03050853 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Kentucky, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03050853 about?
NCT03050853 is a clinical study titled "The Appeal and Impact of E-cigarettes in Smokers With SMI". This study will evaluate behavioral and psychological appeal, toxicity, and effect of e-cigarettes on smoking behavior and nicotine addiction in chronic smokers with serious mental illness (SMI) who have failed to quit smoking. A total of 240 participants will be enrolled and randomly assigned to ei...
What is the current status of trial NCT03050853?
This trial is currently completed. It is a NA study. The enrollment target is 240 participants. The study started on 2017-03-01. Estimated completion is 2021-01-31.
What conditions does trial NCT03050853 study?
This clinical trial studies the following conditions: Schizophrenia, Bipolar Disorder, Schizoaffective Disorder, Tobacco Dependence. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03050853?
The interventions under investigation include: E-cigarette (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03050853?
This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03050853 being conducted?
This trial has 2 study locations across Kentucky, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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