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
|Condition or disease||Intervention/treatment||Phase|
|Tobacco Dependence Schizophrenia Bipolar Disorder Schizoaffective Disorder||Behavioral: E-cigarette||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||240 participants|
|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.|
|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|
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.
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.
- Change in Carbon Monoxide Level [ Time Frame: Baseline, 2 week, 4 week, 6 week, 8 week, 13 week, 26 week ]Carbon Monoxide Measurement
- 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
- Change in the use of e-cigarettes [ Time Frame: Baseline, 2 week, 4 week, 6 week, 8 week, 13 week, 26 week ]
- Change in Nicotine Dependence [ Time Frame: Baseline, 2 week, 4 week, 6 week, 8 week, 13 week, 26 week ]Fagerstrom Test of Nicotine Dependence
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
|United States, Kentucky|
|Louisville, Kentucky, United States, 40211|
|United States, Massachusetts|
|Lawrence, Massachusetts, United States, 01843|
|Principal Investigator:||Sarah I Pratt, Ph.D.||Dartmouth College|