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NCT03050853 · ClinicalTrials.gov registry record · NA

The Appeal and Impact of E-cigarettes in Smokers With SMI

A NA study of Schizophrenia and Bipolar Disorder, sponsored by Dartmouth-Hitchcock Medical Center.

Completed
Registry status
NA
Development phase
240
Enrollment target
2
Study locations

NCT03050853 is a NA study of Schizophrenia and Bipolar Disorder that has completed, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 240 participants, above the 218-participant average among 315 other Schizophrenia trials with a reported enrollment target (10% higher). The trial reports 2 study locations across 2 states.

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The verdict

NCT03050853, a NA study of Schizophrenia and Bipolar Disorder, has completed, sponsored by Dartmouth-Hitchcock Medical Center.

COMPLETED
Registry status
NA
Development phase
240 participants
Enrollment target
2
Study locations

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.

Interventions

  • BEHAVIORAL E-cigarette

Study Locations (2)

Kentucky

  • Centerstone Kentucky - Louisville

Massachusetts

  • Vinfen Corp - Lawrence

Trial Details

FieldValue
Enrollment Target 240 participants
Start Date 2017-03-01
Est. Completion 2021-01-31
Phase NA

Sponsor

Dartmouth-Hitchcock Medical Center

427 total trials

What the Registry Record Tells You About NCT03050853

The ClinicalTrials.gov registry entry for NCT03050853 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 218-participant average among 315 other Schizophrenia trials with a reported enrollment target (10% higher). The listed sponsor is Dartmouth-Hitchcock Medical Center, which has 427 total studies on file at ClinicalTrials.gov.

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.

NCT03050853 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Kentucky, Massachusetts.

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.

What interventions are being tested in trial NCT03050853?

The interventions under investigation include: E-cigarette (BEHAVIORAL).

Who is sponsoring clinical trial NCT03050853?

This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 427 total clinical trials registered on ClinicalTrials.gov.

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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