Clinical trial NCT03050853: The Appeal and Impact of E-cigarettes in Smokers With SMI
Official title: The Appeal and Impact of E-cigarettes in Smokers With Serious Mental Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Dependence
Schizophrenia
Bipolar Disorder
Schizoaffective Disorder
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Vinfen
name: Centerstone Kentucky
First posted: 2017-02-13
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: OTHER

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Carbon Monoxide Level
timeFrame: Baseline, 2 week, 4 week, 6 week, 8 week, 13 week, 26 week
measure: Change in Cancer Related Toxin, 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol or NNAL
timeFrame: Baseline, 4 week, 8 week, 13 week, 26 week
measure: Change in the use of e-cigarettes
timeFrame: Baseline, 2 week, 4 week, 6 week, 8 week, 13 week, 26 week
Secondary outcomes:
measure: Change in Nicotine Dependence
timeFrame: Baseline, 2 week, 4 week, 6 week, 8 week, 13 week, 26 week
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Centerstone Kentucky
state: Kentucky
city: Lawrence
country: United States
facility: Vinfen Corp
state: Massachusetts
Study officials:
affiliation: Dartmouth College
name: Sarah I Pratt, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.