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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03050853
Recruitment Status : Active, not recruiting
First Posted : February 13, 2017
Last Update Posted : December 17, 2020
Sponsor:
Collaborators:
Vinfen Corporation
Centerstone Kentucky
Information provided by (Responsible Party):
Sarah Pratt, Dartmouth-Hitchcock Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Tobacco Dependence Schizophrenia Bipolar Disorder Schizoaffective Disorder Behavioral: E-cigarette Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a study to learn about the appeal and health impacts of using e-cigarettes in people with serious mental illness who are not currently thinking about qutting smoking. Reduction of craving or quitting are not targets
Masking: Single (Outcomes Assessor)
Masking Description: All follow-up assessments will be conducted by the masked outcome assessor with the exception of the tobacco use and e-cigarette use self report and the satisfaction with e-cigarettes scale administered to the intervention group.
Primary Purpose: Other
Official Title: The Appeal and Impact of E-cigarettes in Smokers With Serious Mental Illness
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : August 31, 2020
Estimated Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes

Arm Intervention/treatment
Experimental: E-Cigarette
The E-cigarette arm will be asked to use e-cigarettes in place of regular tobacco products. The group will be assessed at baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 13 weeks, and 26 weeks.
Behavioral: E-cigarette
The e-cigarette arm will be provided with 8 weeks of free e-cigarettes based on self-report of regular tobacco use. Participants assigned in this arm will be asked to switch combustible tobacco with e-cigarettes. The appeal of e-cigarettes and health impacts will be measured, but we are not targeting quitting combustible tobacco or reducing craving.

No Intervention: Assessments only
The Assessment only group will be asked to refrain from use of e-cigarettes during participation. The group will be assessed at baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 13 weeks, and 26 weeks.



Primary Outcome Measures :
  1. Change in Carbon Monoxide Level [ Time Frame: Baseline, 2 week, 4 week, 6 week, 8 week, 13 week, 26 week ]
    Carbon Monoxide Measurement

  2. Change in Cancer Related Toxin, 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol or NNAL [ Time Frame: Baseline, 4 week, 8 week, 13 week, 26 week ]
    Urine NNAL analysis

  3. Change in the use of e-cigarettes [ Time Frame: Baseline, 2 week, 4 week, 6 week, 8 week, 13 week, 26 week ]

Secondary Outcome Measures :
  1. Change in Nicotine Dependence [ Time Frame: Baseline, 2 week, 4 week, 6 week, 8 week, 13 week, 26 week ]
    Fagerstrom Test of Nicotine Dependence



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Diagnosis of Schizophrenia, Schizoaffective Disorder, or Bipolar Disorder
  • Enrolled in services at the research site for a minimum of 3 months
  • Regular smoker (approximately 10 cigarettes for the past 5 years) with a history of at least 1 quit attempt
  • Fluent in English

Exclusion Criteria:

  • Regular use of e-cigarettes in the past month
  • Current interest/plan to quit smoking
  • Regular use of nicotine replacement therapy to quit smoking or use of bupropion or varenicline to quit smoking
  • Use of emergency room or hospitalization for psychiatric reasons in the past 30 days

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03050853


Locations
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United States, Kentucky
Centerstone Kentucky
Louisville, Kentucky, United States, 40211
United States, Massachusetts
Vinfen Corp
Lawrence, Massachusetts, United States, 01843
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Vinfen Corporation
Centerstone Kentucky
Investigators
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Principal Investigator: Sarah I Pratt, Ph.D. Dartmouth College
Publications:
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Responsible Party: Sarah Pratt, Scientist, Psych Research, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT03050853    
Other Study ID Numbers: 29154
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Disease
Tobacco Use Disorder
Schizophrenia
Bipolar Disorder
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Bipolar and Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders