- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03050853
The Appeal and Impact of E-cigarettes in Smokers With SMI
The Appeal and Impact of E-cigarettes in Smokers With Serious Mental Illness
Study Overview
Status
Intervention / Treatment
Detailed Description
The main addictive component in tobacco, nicotine, has very low toxicity in cigarette doses and is available in a novel product, electronic cigarettes (e-cigarettes). E-cigarettes are widely available and popular; almost one-third of cigarette smokers in the general population have tried them. E-cigarette use may be equally common among heavily dependent subgroups of chronic smokers. For example, two studies suggest that smokers with mental illness have tried this product at similar or even higher rates compared with the general population. This proposal targets chronic, highly dependent smokers with serious mental illness (SMI) who have been unable to quit and are thus maintaining exposure to toxins in combustible tobacco smoke. Whether smokers with SMI find e-cigarettes appealing is an important question because substituting e-cigarettes for combustible cigarettes may have profound health effects related to reduced impact on lung function and cardiovascular inflammation, as well as reduced exposure to carcinogens and tumor promoters.
E-Cigarettes are popular and readily available even though information about toxicity, addiction liability, effect on health, and impact on current or future smoking behaviors is limited. Given the ubiquity of e-cigarette use and the lack of definitive data on their impact, more information about their appeal and impact, especially in vulnerable populations who are unable to quit smoking, will be key for regulators and treatment providers. The FDA has published its intention to regulate e-cigarettes, and the National Institute on Drug Abuse (NIDA) is supporting the development of a standardized, safety-tested e-cigarette for use in research. The American Heart Association recently issued a policy statement that e-cigarettes present "an opportunity for harm reduction if smokers adopt this alternative tobacco product as a substitute for cigarettes," but further research on behavioral and psychological appeal, toxicity, and impact of e-cigarettes on smoking heavier and nicotine dependence are sorely needed. The proposed study would add significantly to this science base.
In partnership with the New Hampshire Department of Medicaid, this research group conducted a statewide study of incentives for health behavior change. Over 600 smokers with mental illness were enrolled and randomly assigned to 1 of 3 smoking cessation treatments. Almost 23% of smokers with schizophrenia and 31% of smokers with bipolar disorder had tried an e-cigarette during the 3 months prior to participating in the study, providing evidence for the potential appeal of e-cigarettes among people with SMI who are trying to quit smoking.
These findings led to a preliminary prospective study of e-cigarette use among 19 chronic smokers (9 had bipolar disorder, 10 had schizophrenia) who had tried to quit an average of 3.8 (±8.14) times over the prior year but were no longer seeking cessation treatment. Participants received a 4-week supply of e-cigarettes and instruction on their safe use, and were assessed weekly for a month. Participants sustained a steady level of e-cigarette use over the study period. Overall, participants significantly reduced the number of cigarettes smoked per week from a mean of 191.9 (±159.3) at baseline to 66.7 (±76.3) at the final study visit (t=3.26, df=17, p=.005), confirmed by a significant decrease in mean CO level from 27ppm (±16.9) to 15ppm (±9.2) (t=3.246, df=18, p=.004). Participants rated several aspects of e-cigarette use based on items created for this study, including: 1) enjoyment compared to tobacco cigarettes, 2) satisfaction from e-cigarettes, and 3) willingness to buy e-cigarettes. Ratings were consistently high (>4 on a 5-point Likert type scale) across the 4 weeks. This study provides the basis and justification for conducting a large study using a randomized design to learn more about the behavioral and psychological appeal of e-cigarettes among chronic smokers with SMI, and to explore important aspects of e-cigarette use, including impact on toxicity and nicotine dependence.
This study will evaluate the behavioral and psychological appeal of e-cigarettes among chronic smokers with SMI, it will evaluate the effect of e-cigarettes on markers of tobacco toxicity, and it will evaluate the effect of e-cigarettes on measures of nicotine dependence. A total of 240 people with SMI who are receiving services at 1 of 2 mental health providers (Vinfen Corporation in Lowell/Lawrence MA and Centerstone Kentucky, formerly Seven Counties Services, Inc. in Louisville, KY) will be enrolled and randomly assigned.
The hypothesis is that at least 50% of smokers assigned to the e-cigarette group will use e-cigarettes daily during each of the 8 weeks that they are provided; mean satisfaction of e-cigarettes will be >3 on a 5-point scale; and subjective perception of e-cigarettes will be positive based on responses to a qualitative interview.
Secondly, it is hypothesized that over 8 weeks, reduction in expired breath CO, combustible cigarettes consumed/week, and urine levels of 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol or NNAL (a tobacco-specific carcinogen) will be greater among those assigned to e-cigarettes compared to those assigned to assessment only. Lastly, it is hypothesized that people assigned to e-cigarettes will have similar nicotine dependence at the end of the study period, when compared to people assigned to assessment only.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Kentucky
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Louisville, Kentucky, United States, 40211
- Centerstone Kentucky
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Massachusetts
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Lawrence, Massachusetts, United States, 01843
- Vinfen Corp
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Carbon Monoxide Level
Time Frame: Baseline, 2 week, 4 week, 6 week, 8 week, 13 week, 26 week
|
Carbon Monoxide Measurement
|
Baseline, 2 week, 4 week, 6 week, 8 week, 13 week, 26 week
|
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
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Urine NNAL analysis
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Baseline, 4 week, 8 week, 13 week, 26 week
|
Change in the use of e-cigarettes
Time Frame: Baseline, 2 week, 4 week, 6 week, 8 week, 13 week, 26 week
|
Count of e-cigarettes
|
Baseline, 2 week, 4 week, 6 week, 8 week, 13 week, 26 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Nicotine Dependence
Time Frame: Baseline, 2 week, 4 week, 6 week, 8 week, 13 week, 26 week
|
Fagerstrom Test of Nicotine Dependence
|
Baseline, 2 week, 4 week, 6 week, 8 week, 13 week, 26 week
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sarah I Pratt, Ph.D., Dartmouth College
Publications and helpful links
General Publications
- Benowitz NL. Clinical pharmacology of nicotine: implications for understanding, preventing, and treating tobacco addiction. Clin Pharmacol Ther. 2008 Apr;83(4):531-41. doi: 10.1038/clpt.2008.3. Epub 2008 Feb 27.
- Etter JF, Bullen C. Electronic cigarette: users profile, utilization, satisfaction and perceived efficacy. Addiction. 2011 Nov;106(11):2017-28. doi: 10.1111/j.1360-0443.2011.03505.x. Epub 2011 Jul 27.
- Polosa R, Rodu B, Caponnetto P, Maglia M, Raciti C. A fresh look at tobacco harm reduction: the case for the electronic cigarette. Harm Reduct J. 2013 Oct 4;10:19. doi: 10.1186/1477-7517-10-19.
- Pratt SI, Sargent J, Daniels L, Santos MM, Brunette M. Appeal of electronic cigarettes in smokers with serious mental illness. Addict Behav. 2016 Aug;59:30-4. doi: 10.1016/j.addbeh.2016.03.009. Epub 2016 Mar 19.
- Pratt SI, Ferron JC, Brunette MF, Santos M, Sargent J, Xie H. E-Cigarette Provision to Promote Switching in Cigarette Smokers With Serious Mental Illness-A Randomized Trial. Nicotine Tob Res. 2022 Aug 6;24(9):1405-1412. doi: 10.1093/ntr/ntac082.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 29154
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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