Public Health Consequences of E-Cigarettes (2018) / Chapter Skim
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8 Dependence and Abuse Liability
8 Dependence and Abuse Liability
Pages 255-338
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From page 255... ...
As with other substance use disorders, tobacco dependence1 is characterized by unpleasant withdrawal symptoms and loss of behavioral control over use, which result in dependent individuals spending considerable time obtaining or using combustible tobacco cigarettes, interfering with the ability to fulfill important social or occupational role obligations and having a variety of other social and physical consequences (Fiore et al., 2008; Volkow et al., 2016)
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From page 256... ...
. While nicotine is necessary, the pharmacological action of nicotine is not sufficient to account for the high addiction potential of combustible tobacco cigarettes (Rose, 2006)
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From page 257... ...
and the drug itself synergize to account for the high addiction potential of combustible tobacco cigarettes. Given what is known about the role of nicotine and non-nicotine factors in tobacco product dependence, it is plausible that e-cigarette use may cause dependence symptoms, and the reason may not be explained merely by the fact the e-cigarettes are a nicotine delivery device.
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From page 258... ...
Hence, whether e-cigarettes cause dependence and what the relative magnitude of risk is relative to combustible tobacco cigarettes are questions that cannot be answered solely by the translation of knowledge about nicotine and combustible cigarettes and necessitate a review of the empirical evidence. Furthermore, given the wide variety of products that may alter the nicotine delivery and sensory experience of e-cigarettes, it is plausible that variations in e-cigarette product characteristics affect risk of dependence.
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From page 259... ...
) , or on a continuum with a score BOX 8-1 Criteria for Tobacco Use Disorder from the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, 5th Edition A problematic pattern of tobacco use leading to clinically significant impairment or distress, as manifested by at least two of the following factors, occurring within a 12-month period: 1.
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From page 260... ...
. There is a welldeveloped literature applying the abuse liability paradigm to combustible tobacco cigarettes and, more recently, emerging literature on the abuse liability of non-traditional tobacco products with specific methodological guidelines put forth from tobacco product abuse liability testing experts (Carter et al., 2009; Henningfield et al., 2011)
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From page 261... ...
In addition, studies of the association between levels of e-cigarette exposure and likelihood of dependence would also provide key data, with evidence of a dose–response being supportive of greater dependence risk caused by e-cigarette use. A critical confounder is the use of other tobacco products (namely, combustible tobacco cigarettes)
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From page 262... ...
. Null findings by studies with active controls (or evidence that e-cigarettes have less abuse liability than combustible tobacco cigarettes)
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From page 263... ...
An important consideration is the type of outcomes that could be considered evidence of abuse liability in studies that conduct controlled tests of e-cigarette administration. Several controlled laboratory studies of combustible tobacco cigarette smokers who have been acutely deprived of nicotine test the effects of e-cigarette use administration on nicotine withdrawal symptoms, combustible tobacco cigarette craving, and other factors believed to maintain smoking behavior.
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From page 264... ...
; mere reporting on the frequency of use was not considered relevant to dependence. The abuse liability literature was used as supportive evidence.
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From page 265... ...
Because such studies are typically in smaller and non-representative samples, they were used as additional epidemiological evidence. Human laboratory studies of the effects of e-cigarettes (versus a comparator other than combustible tobacco cigarettes)
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From page 266... ...
Poly-product users of e-cigarettes and combustible tobacco products reported higher prevalence of most symptoms than exclusive e-cigarette, combustible tobacco cigarette, and cigar smokers. Given the representative sampling, this study provides strong evidence on dependence symptom prevalence estimates in the United States.
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From page 267... ...
Hence, the generalizability to the current environment is questionable and there is a possibility that e-cigarette prevalence estimates may be different than what would be observed today. In sum, this study provides strong evidence that dependence symptoms are common among daily e-cigarette users and suggestive evidence that the probability of experiencing dependence symptoms is lower for e-cigarettes compared with combustible tobacco cigarettes and not different in comparison to cigars.
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From page 268... ...
: time to first tobacco use after waking, whether or not respondents sometimes wake at night 60,192 total respondents, to use a tobacco product, have had a strong daily single tobacco craving to use any tobacco product in the product users: past 30 days, have felt like they really needed n = 124 e-cigarettes to use a tobacco product in the past 30 days, n = 131 cigars have had a time when they wanted to use a n = 3,963 combustible tobacco product so much that it was difficult tobacco cigarettes to think of anything else in the past 30 days, if the statement that they feel restless or irritable after not using tobacco for a while was "not at all true," "sometimes true," "often true," or "always true."
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From page 269... ...
were significantly more likely to report strong craving for tobacco in past 30 days compared with exclusive combustible tobacco cigarette smokers. Symptoms were less prevalent in users of only e-cigarettes and only cigars than people who used both combustible tobacco cigarettes and cigars (e.g., exclusive e-cigarette users reported longer median time to first use than exclusive combustible tobacco cigarette smokers)
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, and Time to First Tobacco tobacco cigarette–only Use [1 item]
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From page 271... ...
among combustible tobacco cigarette–only users, mean tobacco dependence was more than a full standard deviation lower for e-cigarette–only users (mean = −1.37, SD = 2.36) , cigar-only users (mean = −1.92, SD = 2.11)
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combustible tobacco cigarette smokers, and current e-cigarette users
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From page 273... ...
Presence of nicotine in e-liquid and length of e-cigarette use (less than or more than 1 year) were significantly associated with nicotine dependence scores.
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From page 274... ...
274 PUBLIC HEALTH CONSEQUENCES OF E-CIGARETTES TABLE 8-1 Continued Reference Study Population Dependence Measure Etter, 2015 374 adult daily users Online non-representative survey of e-cigarettes who had Used adapted FTND, NDSS, CDS tools to quit smoking in the assess dependence on e-cigarettes; also previous 62 days measured urge to use e-cigarette with MPSS (2 items) ; used modified version item of craving subscale of WSWS Etter and 1,284 adult daily users of Used adapted FTND, NDSS, CDS tools to Eissenberg, 2015 e-cigarettes assess dependence on e-cigarettes and nicotine gum; also measured unsuccessful attempts to quit product, and perceptions of likeliness to succeed if stopped using product and addiction to e-cigarette or nicotine gum compared with combustible tobacco cigarette
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From page 275... ...
Users who said e-cigarettes "definitely" decreased tobacco cravings were more likely to report e-cigarettes also alleviated withdrawal symptoms such as anxiety, nervousness, anger, irritability, frustration, depressed mood, sadness, restlessness, impatience, mood swings compared with those who said e-cigarettes had a weak effect on craving. Ex-smokers who used only e-cigarettes + + + reported significantly lower time to first cigarette when smoked combustible tobacco cigarettes versus time to first e-cigarette; time to first e-cigarette less than 30 minutes on average.
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From page 276... ...
276 PUBLIC HEALTH CONSEQUENCES OF E-CIGARETTES TABLE 8-1 Continued Reference Study Population Dependence Measure Etter, 2016 1,672 adult current users Online non-representative survey of e-cigarettes (daily and occasionally)
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From page 277... ...
. "I am a prisoner of the electronic cigarette" (% agree: very weak = 17%; rather weak = 21%; average = 26%; rather strong = 28%; very strong = 19%; χ2 = 43.3; p < 0.001)
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278 PUBLIC HEALTH CONSEQUENCES OF E-CIGARETTES TABLE 8-1 Continued Reference Study Population Dependence Measure Etter, 2016 continued
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. "Former smokers: addiction to e-cigarette compared with former addiction to tobacco cigarette" (% same or stronger: very weak = 12%; rather weak = 15%; average = 25%; rather strong = 25%; very strong = 23%; χ2 = 49.7; p < 0.001)
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From page 280... ...
280 PUBLIC HEALTH CONSEQUENCES OF E-CIGARETTES TABLE 8-1 Continued Reference Study Population Dependence Measure Foulds et al., 3,609 adult former Penn State Cigarette Dependence Index and 2015 combustible tobacco PSECDI cigarette smokers who currently use e-cigarettes Yingst et al., Current advanced- Online survey asking, "Did you switch to your 2015 generation e-cigarette current preferred type of e-cigarette because device users (n = 3,373) ; it gives you a more satisfying "hit" than Current first-generation previous e-cigarettes your tried?
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From page 281... ...
More than 90% reported they had experienced strong urges to smoke and withdrawal symptoms when a smoker, but only 25–35% reported experiencing these symptoms of dependence as an e-cigarette user. Those who have used e-cigarettes for a longer time, who have previously tried more e-cigarette models, who currently use an e-cigarette larger than a combustible tobacco cigarette, with a button, with more than one battery, that cost more than $50, and who use a higher concentration of nicotine liquid tend to have a higher e-cigarette dependence index (all p < 0.05)
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From page 282... ...
nicotine liquid conditions in two separate sessions Goldenson et 20 e-cigarette users (≥1 PSECDI; FTCD al., 2016 day per week for ≥1 month; smoking ≤15 combustible tobacco cigarettes per day; no use of smoking cessation medication) Hobkirk et al., 9 adult past-month (≥20 PSECDI 2017 in the past 28 days)
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out of a possible score range of 0–20. PSEDCI: low to medium levels of + e-cigarette dependence (mean = 7, SD = 3)
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284 PUBLIC HEALTH CONSEQUENCES OF E-CIGARETTES TABLE 8-2 Laboratory/Experimental Studies on Dependence and Abuse Liability Study Reference Study Design Population Device Measure Studies Testing the Effects of Flavor Audrain- Laboratory 32 young "e-GO" tank-style e-cigarette with a 2.4McGovern et adult ml refillable e-liquid tank al., 2016 combustible 2 flavored e-liquid options: fruit-flavored tobacco (green apple) , and dessert-flavored cigarette (chocolate)
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e-cigarette puffs as non-menthol combustible tobacco cigarette smokers. continued
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286 PUBLIC HEALTH CONSEQUENCES OF E-CIGARETTES TABLE 8-2 Continued Study Reference Study Design Population Device Measure Goldenson et Laboratory 20 e-cigarette Joyetech "Delta 23 Atomizer" tanks al., 2016 and used users (≥1 day connected to a Joyetech "eVic Supreme" epidemiological per week for battery data ≥1 month; 20 e-cigarette solutions in 10 flavors smoking ≤15 were either 0 or 6 mg/ml nicotine (10 combustible flavors included 6 sweet-flavored [peach, tobacco watermelon, blackberry, cotton candy, cigarettes per cola, and sweet lemon tea] , 3 non-sweet day; no use flavored [mint, tobacco, and menthol]
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Liking was Hedonic Scale low and did not vary significantly across menthol or nicotine concentrations. continued
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e-liquids and ranged between 3–18 mg/ml in the usual brands (mean pH = 6.80)
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. Negative Affect Usual brand e-liquids Schedule, and had significantly modified Cigarette more satisfaction and Evaluation enjoyment of sensations Questionnaire than experimenter provided liquids.
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290 PUBLIC HEALTH CONSEQUENCES OF E-CIGARETTES TABLE 8-2 Continued Study Reference Study Design Population Device Measure Studies Testing the Effects of Nicotine Concentration Baldassarri et Laboratory Adult "e-Go type e-cigarette"; nicotine al., 2017 and experienced concentrations with a linear range of epidemiological e-cigarette 0.5–50 µg/ml users (n = 4) and cigarette smokers (n = 3)
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. Liking following use of the combustible tobacco cigarette was (37 ± 40)
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From page 292... ...
" for tobacco menthol flavors cigarette smokers (n = 28) in a fully within subjects design Rosbrook and Laboratory 18–45 years Challenge study, controlled e-cigarette use Green, 2016, of age Experiment #1 (n = 32)
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From page 293... ...
General Labeled No significant effects − − Magnitude Scale of menthol or nicotine and Labeled on liking. Liking was Hedonic Scale low and did not vary significantly across menthol or nicotine concentrations.
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294 PUBLIC HEALTH CONSEQUENCES OF E-CIGARETTES TABLE 8-2 Continued Study Reference Study Design Population Device Measure Rosbrook and Laboratory 18–45 years Challenge study, controlled e-cigarette use Green, 2016, of age Experiment #2 (n = 32)
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DEPENDENCE AND ABUSE LIABILITY 295 E-Cigarettes Have Lower Dependence Potential Product E-Cigarettes Than Characteristics Have Some Combustible Alter Dependence Dependence Tobacco Dependence Measure Results Risk? Cigarettes?
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The three devices were presented without brand style information and were visually indistinguishable by subjects.
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From page 297... ...
on Urge to Smoke, the Product Liking Urge for Product, questionnaire were Intent to Use substantially lower for Product Again, the three Vuse Solo Product Effects e-cigarettes compared with the combustible tobacco cigarette condition (LS [least square] mean Emax scores ranging from 4.13 to 4.57, LS mean Emax = 9.06, p < 0.001 for all, respectively)
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From page 298... ...
298 PUBLIC HEALTH CONSEQUENCES OF E-CIGARETTES TABLE 8-2 Continued Study Reference Study Design Population Device Measure Strasser et al., Trial 28 e-cigarette– 5 first-generation design brands: NJOY, 2016 naïve current 18 mg nicotine; V2, 18 mg nicotine; Green combustible Smoke, 18.9–20.7 mg nicotine; blu, 20–24 tobacco mg nicotine; and White Cloud, 23–24 mg cigarette nicotine smokers Vansickel et Laboratory 32 e-cigarette– 16–18 mg/ml first-generation devices al., 2010 naïve that didn't give nicotine yield in blood. combustible Users' own brand of combustible tobacco tobacco cigarettes versus sham (unlit combustible cigarette tobacco cigarette)
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Risk? Withdrawal Compared with + Symptom combustible tobacco Checklist and cigarette smoking, questionnaire of e-cigarettes provided Smoking Urges significantly lower nicotine levels (25–50%)
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300 PUBLIC HEALTH CONSEQUENCES OF E-CIGARETTES TABLE 8-2 Continued Study Reference Study Design Population Device Measure Vansickel et Laboratory 20 e-cigarette– "Vapor King" (KR808 model) automatic al., 2012 naïve e-cigarette, 18 mg combustible tobacco cigarette smokers Clinical Trials Meier et al., Laboratory/ 24 adult blu cigarette starter kit with up to seven 2017 Crossover combustible cartridges prefilled with 16-mg nicotine tobacco solution cigarette smokers, no vaping in past Within a double-blind randomized 6 months crossover design, smokers (n = 24; 75% male; mean age = 48.5 years)
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From page 301... ...
. Crossover values were greater in the own brand versus money choice condition relative to the e-cigarette versus money choice condition.
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From page 302... ...
Regression analyses adjusted for demographics showed that, relative to exclusive daily combustible tobacco cigarette users, exclusive daily e-cigarette users reported lower prevalence for each dependence symptom and longer time to first use. A strength of this study was the report on the product characteristics used among the e-cigarette users, which provides information generalizability on a key source of potential variability in dependence risk (i.e., device type)
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From page 303... ...
E-cigarettes scored significantly lower on aversion scores than combustible tobacco cigarettes. Compared with inhaler, e-cigarettes scored higher on measures of perception such as helpful for not smoking and effective for quitting, similar to combustible tobacco cigarettes, acceptable to smokers, and cool image.
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From page 304... ...
Consequently, the prevalence estimates reported may be less than what would be observed for e-cigarette users who have little history of use of other tobacco products. Finally, some the symptoms are likely to be less valid indicators of the underlying addiction to e-cigarettes as compared with combustible tobacco cigarettes.
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From page 305... ...
For example, the study found that reporting difficulty refraining from using the product in places where it was prohibited was less strongly associated with the latent dependence dimension for exclusive e-cigarette users than for combustible tobacco cigarette users. This may be due in part to less comprehensive indoor air quality restrictions against e-cigarette use than combustible tobacco cigarette use, making this particular symptom a less relevant indicator of e-cigarette dependence than of combustible tobacco cigarette dependence.
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From page 306... ...
. Yes 7 WISDM: Primary Loss of control Tobacco products control me.
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From page 307... ...
DSM = Diagnostic and Statistical Manual of Mental Disorders; HONC = Hooked on Nicotine Checklist; NDSS = Nicotine Dependence Syndrome Scale; WISDM = Wisconsin Inventory of Smoking Dependence Motives. SOURCE: Strong et al., 2017.
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From page 308... ...
In addition to providing precise mean dependence severity estimates of e-cigarette users relative to other user groups, this study shows that frequency of e-cigarette use is significantly associated with severity of dependence. This provides additional evidence that, as with combustible tobacco cigarettes and other drugs of abuse, dependence severity is higher among those who use more frequently.
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From page 309... ...
Of the sample, 10 percent also used combustible tobacco cigarettes. This low prevalence may reflect a selection bias.
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From page 310... ...
and current combustible tobacco cigarette smokers (n = 42, men = 57 percent)
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From page 311... ...
The analysis was limited to 3,609 respondents who were exclusive current daily e-cigarette users who had not smoked combustible tobacco cigarettes in the past 30 days. Participants were asked to report on 10 dependence symptoms that compose the Penn State Electronic Cigarette Dependence Index (PSECDI)
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From page 312... ...
The non-representative sample is a limitation, but the fairly large sample is a strength. In sum, this study provides suggestive evidence that e-cigarette dependence symptoms are of appreciable severity and lower than for combustible tobacco cigarettes.
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From page 313... ...
Participants recruited on e-cigarette retailer websites completed a Web survey on e-cigarette dependence and use characteristics, including several survey questions addressing factors relevant to dependence and abuse liability. In the whole sample, the proportion of survey responses indicating the highest level of endorse
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From page 314... ...
In sum, this study provides weak suggestive evidence in support of dependence symptoms (and abuse liability to some degree) in e-cigarette use that is lower than corresponding dependence in combustible tobacco use.
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From page 315... ...
Overall, this study provides additional suggestive evidence that dependence symptoms and experiences indicative of abuse liability are of moderate to high prevalence and severity and may be higher in those who obtain a stronger throat hit from their product. In sum, the collective papers across these three studies provide suggestive evidence that e-cigarette dependence symptoms and subjective effects of vaping indicative of abuse liability are of appreciable prevalence and severity in samples of users and may be associated with nicotine concentration and user characteristics.
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From page 316... ...
Three of these five studies as well as three additional studies also addressed the effect of varying e-cigarette nicotine concentration on abuse liability. Four studies compared the effects of e-cigarette administration with combustible tobacco cigarette administration among smokers.
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From page 317... ...
. In sum, this study provides fairly strong evidence that sweet flavorings enhance subjective abuse liability indexes in young adults and provides limited evidence regarding the impact of nicotine on abuse liability.
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From page 318... ...
= 2.028; 95% CI = 1.183–3.475; p = 0.01) . The study strengths include the use of three different abuse liability outcomes, each of which provides unique information about abuse liability (i.e., one addressing the subjective experience, one addressing the motivation to obtain the product, one addressing self-administration under unconstrained conditions)
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From page 319... ...
is unknown. Overall, the study provides clear and consistent evidence across three different types of abuse liability outcomes indicating that sweet-flavored products produced higher abuse liability than unflavored products in young adult smokers.
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From page 320... ...
, 11 men and 3 women participated in a 3-day inpatient crossover study with strawberry, tobacco, and their usual flavor e-liquid on subjective product liking ratings indicative of abuse liability and other outcomes. Exclusive e-cigarette users or dual users of fewer than five combustible tobacco cigarettes per day, who used second- and/or third-generation e-cigarettes at least 25 days per month for the past 3 months or more and had saliva cotinine levels at least 30 ng/ml were eligible.
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From page 321... ...
Hence, the study sample size, although appropriate for studying effects on nicotine blood yield, was underpowered to detect meaningful effects for subjective abuse liability–relevant outcomes. Nonetheless, the controlled design, inclusion of both standardized and ad lib testing conditions, and inclusion of regular e-cigarette users with experimentally controlled tobacco product deprivation enhances the internal validity of the study, particularly for the standardized session test results.
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From page 322... ...
At the same time, there is ecological validity to be gained by the using the participants' own e-liquids given their ability to self-select the product likely to be highly rewarding to their own preferences. In sum, the study provides tentative evidence that self-selected e-liquids produce greater satisfaction and potential other indicators of abuse liability than experimenter-provided e-liquids in experienced e-cigarette users.
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From page 323... ...
Taken together, these findings provide tentative evidence that nicotine may enhance some subjective effects indicative of abuse liability; however, no firm conclusion can be drawn due to the absence of statistically significant results (p = 0.09 to 0.11)
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From page 324... ...
In sum, this study provides rigorous evidence that e-cigarettes with a high dose of nicotine versus placebo increase abuse liability ratings among combustible tobacco cigarette-dependent smokers. A study conducted by Baldassarri and colleagues (2017)
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From page 325... ...
Comparisons of E-Cigarettes to Combustible Tobacco Cigarettes and Other Products In 28 e-cigarette–naïve current smokers, Strasser and colleagues (2016) compared the effects of own-brand combustible tobacco cigarette smoking on abuse liability outcomes versus an e-cigarette product as a within-subject design factor.
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From page 326... ...
evaluated the abuse liability of three e-cigarettes (Vuse Solo brand, labeled nicotine concentrations of 14, 29, or 36 mg per e-liquid cartridge; solvent, flavoring additives, or characterizing labels and device properties not reported) relative to "high- and lowabuse liability" comparator products (usual brand combustible tobacco cigarettes and nicotine gum, respectively)
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From page 327... ...
and combustible tobacco cigarettes (higher abuse liability) among e-cigarette–naïve smokers.
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From page 328... ...
b = Significantly different from nicotine gum, p < 0.05. SOURCE: Stiles et al., 2017.
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From page 329... ...
Participants completed a behavioral choice abuse liability task evaluating the relative reinforcing value of e-cigarette and usual brand combustible tobacco cigarettes versus money; subjective abuse liability ratings were also collected. Participants were given a "Vapor King" (KR808 model)
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From page 330... ...
In sum, this study provides strong evidence that e-cigarettes possess abuse liability in regular smokers and suggestive evidence that the relative abuse liability is lower than the smoker's usual combustible tobacco cigarette brand used. In a study by Vansickel and colleagues (2010)
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From page 331... ...
Nonetheless, there were still some differences between these products and the sham condition. In sum, this study provides additional suggestive evidence that e-cigarette products may carry some abuse liability, but not at levels as high as combustible tobacco cigarettes.
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From page 332... ...
This was followed by a 3-day washout period, during which participants were instructed to smoke their usual combustible tobacco cigarettes as they wished before using the next product. To gain insight into craving and satisfaction during the product use periods, subjects were instructed to use the e-cigarettes and nicotine inhalers as combustible tobacco cigarette substitutes, but were told that cigarette smoking was permissible if absolutely necessary.
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Conclusion 8-2. There is moderate evidence that risk and severity of dependence are lower for e-cigarettes than combustible tobacco cigarettes.
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2009. Abuse liability assessment of tobacco products including potential reduced exposure products (PREPs)
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2015. Dependence levels in users of electronic cigarettes, nico tine gums and tobacco cigarettes.
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From page 336... ...
2015. Electronic cigarette effectiveness and abuse liability: Predicting and regulating nicotine flux.
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From page 337... ...
2017. Pharmacodynamic and pharmacokinetic assessment of electronic cigarettes, combus tible cigarettes, and nicotine gum: Implications for abuse liability.
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