Nicotine replacement therapy for vaping cessation among mono and dual users: A mixed methods preliminary study

Abstract

Many adults express interest in e-cigarette cessation; however, there are few empirically tested interventions for quitting vaping. This study seeks to 1) to evaluate reasons for quitting e-cigarettes in treatment-seeking adults, and 2) to assess the feasibility and acceptability of nicotine replacement therapy (NRT) for e-cigarette cessation. Adult daily e-cigarette users completed qualitative interviews about quitting e-cigarettes, then were randomized to either 28-day supply of combination NRT (21mg patches, 4mg lozenges) + supportive booklet or Quitline referral. Primary aims were feasibility (number who enrolled) and acceptability (NRT use, adverse side effects). Exploratory aims evaluated abstinence (7-day point-prevalence) at end of treatment. Of the 30 participants who were enrolled, 50% (n=15) were dual users, and 50% (n=15) were mono-vapers, 26.6% (n=8) of whom were former smokers. Participants reported seeking treatment due to health concerns, dependence, stigma, and cost. Anticipated challenges of quitting vaping were withdrawal, negative mood, sensorimotor habits, and convenience. Most completed the end of treatment survey (n=24; 80%). Participants who received NRT reported using the patch M=10.89 days and lozenges M=6.39 days, with few days of adverse effects (M=2.67). At end of treatment, 6/18 (33.3%; 6 mono and 0 dual users) in the intervention group reported abstinence from vaping, compared to 0 in the control group (Fisher=5.00, p=.057). In conclusion, adults are interested in quitting e-cigarettes due to negative consequences of use and are willing to use pharmacotherapy. Future research should confirm these results in a larger trial, address cigarette smoking in dual users, and aim to disseminate treatments.

1.0. INTRODUCTION

With the significant increase and proliferation of e-cigarettes in the tobacco marketplace¹, prevalence of e-cigarette use is estimated to be 3.7% as of 2020². Among adults who vape, about 54% concurrently smoke cigarettes, 31% smoked in the past, and 15% never smoked cigarettes³. Nicotine is an addictive stimulant⁴, and many youth who use e-cigarettes report symptoms of dependence⁵, such as cravings, tolerance, habitual vaping, and inability to track consumption due to accessibility and convenience^6,7. Dependence symptoms in adults are less well understood; however, many report perceived negative health effects^8–15, cost concerns^10,16–18, and withdrawal¹⁹. Individuals who use e-cigarettes may be prompted to consider cessation due to dependence and other negative consequences. Indeed, national survey data suggest that 60.7% of adults are interested in quitting e-cigarettes, with 15.7% endorsing a past year quit attempt³. Highest intention to quit is seen among those who smoked in the past, whereas highest prevalence of past year quit attempts is among those who never smoked.

Although many individuals report interest in quitting, there are very few empirically tested interventions to address e-cigarette cessation. One study of text-message support²⁰, two using contingency management^21,22, and one using counseling, nicotine replacement therapy (NRT), and nicotine tapering²³ have shown promise for quitting vaping. The text-message program^20,24 was the only fully-powered randomized controlled trial, which provided behavioral support via text to youth and young adults interested in quitting vaping and self-reported abstinence at the end of the program. Two case studies also show support for NRT for vaping cessation^25,26. Importantly, the aforementioned studies were tailored for youth and young adults (ages 17–31). Limited research has been conducted evaluating methods for e-cigarette cessation among the general adult population. Additionally, there is a lack of treatment resources specifically addressing dual users of cigarettes and e-cigarettes, which is a common and troubling phenomenon given the health consequences of continued combustible cigarette smoking^19,27. Finally, there is concern that quitting e-cigarettes may lead to increased smoking in dual users, or put individuals who used to smoke at risk of relapse²⁸. No longitudinal research exists to examine these effects.

The purpose of the present study is to address these gaps through 1) a qualitative analysis of reasons for quitting e-cigarettes in treatment-seeking adults and 2) an investigation of the feasibility and acceptability of NRT plus supportive written materials for e-cigarette cessation through a preliminary clinical trial. The results of this study aim to inform e-cigarette interventions for the general adult population by evaluating motivators and barriers for quitting as well as gaining a preliminary appraisal into the application of an established smoking cessation treatment for vaping cessation.

2.0. METHODS

2.1. Participants

Participants were recruited to the study via online advertisements (Craigslist) across South Carolina. Advertisements were tailored explicitly for both e-cigarette-only (mono) users and dual-users interested in quitting such that equal numbers of mono- (n=15) and dual-users (n=15) were recruited. Participants were given a link to an online survey via REDCap²⁹ to determine study eligibility, and all participants were screened over the phone to confirm. Randomization was stratified by cigarette smoking status (e-cigarette-only OR cigarette smoking ≥1x per week [dual user]).

Inclusion criteria included 1) age 18+; 2) daily nicotine-containing e-cigarette use (25+ days per month); 3) vaping 5+ times/day; 4) vaping ≥ 1 year; 5) interest in quitting vaping [and smoking, for dual users] within the next month (≥7 on 10-point scale); 6) willingness to try NRT; 7) able to receive text messages and to complete interviews over the phone or via video software; and 8) live in South Carolina. Exclusion criteria included participants who were pregnant or not using contraception, cognitively impaired, household members of study participants, used any other non-cigarette tobacco product or cessation medication, or endorsed a current medical condition that was contraindicated for NRT use.

2.2. Study Procedures

The study was approved by the Institutional Review Board. Participants who were eligible scheduled a video meeting with research staff where informed consent was obtained. All participants then completed a qualitative interview and baseline assessments. Finally, participants were randomized into study group at a target ~2:1 ratio; however, due to the small sample size, this exact ratio was not achieved: Intervention (n=18), Control (n=12).

Participants assigned to the Intervention condition were asked to pick a day to quit vaping (and smoking, if applicable) within 1 week. Participants were then mailed a 28-day supply of 21 mg nicotine patches, 4 mg lozenges, and a support booklet. The support booklet was developed by modifying the existing booklet utilized by the MUSC Tobacco Treatment Program which was based on cognitive-behavioral therapy skills³⁰. For the present intervention, text was adapted to provide skills for e-cigarette cessation or dual product cessation, resulting in two separate booklets for each type of participant (one for mono-users detailing e-cigarette cessation, one for dual users detailing both smoking and e-cigarette cessation). On the specified quit day, participants received a supportive text message (“Today is your quit date! Make sure to use your medications and written materials to help you. You got this!”). After this, participants received daily surveys via text message over the course of 28 days.

Participants in the Control condition were provided with information about how to contact the SC Quitline (call, text, online)³¹ and were encouraged to enroll in services within 1 week. Participants were told that the quitline offered pharmacotherapy, an e-cigarette cessation protocol³², and smoking cessation support if applicable. Given that the purpose of the study was to evaluate the feasibility and acceptability of the intervention described, the control group did not complete daily surveys.

At the end of treatment (EOT; Day 28) and follow-up (FU; Day 56), all participants received text message survey links to complete assessments. Participants were compensated $20 for each assessment completed (baseline, Day 28, Day 56; maximum $60). Participants in the Intervention condition were compensated an additional $60 for completing daily surveys, based on the number completed (i.e., 1 completed = $10, 14 = $40, 28 = $60). All payments were in the form of electronic gift cards.

2.3. Measures

2.3.1. Qualitative Interviews

Prior to trial onset, participants engaged in a brief interview over video software regarding their interest in the study. Participants were asked 1) “Tell me about why you are interested in quitting e-cigarettes (and cigarettes, if applicable).”; 2) “Have you talked to a medical professional about your e-cigarette use? What was that like/what do you think it would be like?”; and 3) “What do you think the challenges will be when quitting e-cigarettes (and smoking)?” Interviews were audio recorded.

2.3.2. Baseline and Follow-up Assessments

Participants completed questionnaires assessing demographics, current/past e-cigarette use characteristics, and current/past cigarette smoking characteristics (if applicable). E-cigarette dependence was measured with the Penn State Electronic Cigarette Dependence Inventory (ECDI; score range 0–20)³³, current withdrawal symptoms was measured using the Brief Wisconsin Inventory of Smoking Dependence Motives (WISDM; total score range = 11–77) adapted to ask about e-cigarettes³⁴, and reinforcing effects of e-cigarettes were measured using the Vaping Consequences Questionnaire (VCQ; Negative Consequences, Positive Reinforcement, Negative Reinforcement, and Weight Control subscales score range 0–9)³⁵. At EOT and FU, measures related to e-cigarette use and cigarette smoking were readministered.

2.3.3. Daily Surveys

Daily surveys sent to participants randomized into the intervention group were asked to self-report (yes/no) e-cigarette use, cigarette use, quit attempts for either product, and NRT use. Finally, participants were able to report adverse events (e.g., common symptoms) of NRT use.

2.4. Outcomes

2.4.1. Feasibility and Acceptability

Feasibility was assessed by 1) the number of participants who reported interest in the study and enrolled; 2) the number of participants who completed the EOT and follow-up visits; and 3) the number of daily surveys completed. Acceptability was assessed by uptake of NRT use as well as reported adverse side effects.

2.4.2. Abstinence and Quit Attempts

Vaping and smoking abstinence at EOT and FU were determined by self-reported 7-day point prevalence abstinence. Vaping and smoking reduction were determined by subtracting the current days of use at EOT and FU from the baseline, and categorizing responses into 1) increased; 2) decreased; or 3) no change. Missing data were imputed as vaping/smoking (not abstinent) or no attempt to quit or reduce vaping³⁶.

2.5. Analysis

2.5.1. Qualitative Analysis

Interview recordings were transcribed and the qualitative analysis was conducted using Taguette³⁷. To begin, an initial set of codes were generated a priori based on the interview questions and a cursory review of transcripts. A subset (~20%) of transcripts were coded by three independent coders, and following completion, coders conferred to revise the codebook and discuss discrepancies. Once a final codebook was agreed upon, each transcript was coded by two coders. Tagged quotes were merged and compared for reliability among coders and discrepancies were discussed to obtain consensus.

2.5.2. Feasibility, Acceptability, and Outcomes

Descriptive statistics for sample characteristics, feasibility, and acceptability were computed. Fisher’s tests were used to determine differences in proportions of participants who were abstinent between treatment groups. Exploratory analyses included the comparison of mono- versus dual users as well as an evaluation of the daily survey data between those in the treatment group who quit and those who did not.

3.0. RESULTS

3.1. Participants

Figure 1 shows the CONSORT flow diagram. From June through December 2021, 196 participants expressed interest in the study which allowed for a final enrolled sample of 30 participants.

Figure 1.

CONSORT flow diagram.

Participant demographics, vaping characteristics, and smoking characteristics can be seen in Table 1. The average age of participants was 32; 50% male; 33.3% identified as a racial or ethnic minority. A majority of participants endorsed vaping continuously all day (76.6%) and using a nicotine content of 50mg/ml/5% or higher (66.6%). Among mono users, 53.3% endorsed a history of regular cigarette smoking. Most current dual users (80%) reported smoking 10 cigarettes or less per day. Participants reported moderate nicotine dependence as evidenced by Brief WISDM total score (M=48.06) and ECDI score (M=13.83).

Table 1.

Participant demographics, vaping characteristics, and smoking characteristics.

	Intervention (N=18)		Control (N=12)		Full Sample
	E-cigarette only (N=10)	Dual User (N=8)	E-cigarette only (N=5)	Dual User (N=7)
Age (mean, SD)	28 (7)	33 (11)	32 (11)	37 (15)	32 (11)
Range: 20–59
Gender identity (N, %)
Male	3 (30%)	6 (75%)	4 (80%)	2 (28.5%)	15 (50%)
Female	7 (70%)	2 (25%)	1 (20%)	5 (71.4%)	15 (50%)
Race or Ethnicity (N, %)
Native American/Alaskan Native	1 (10%)	0	0	0	1 (3.3%)
Black/African American	2 (20%)	0	1 (20%)	3 (42.8%)	6 (20%)
Hispanic	1 (10%)	1 (12.5%)	0	0	2 (6.6%)
South Asian	0	0	1 (20%)	0	1 (3.3%)
White	6 (60%)	7 (87.5%)	3 (60%)	4 (57.1%)	20 (66.6%)
Marital Status (N, %)
Single, never married	6 (60%)	5 (62.5%)	3 (60%)	4 (57.1%)	18 (60%)
Married/Partnered	3 (30%)	1 (12.5%)	1 (20%)	0	5 (16.6%)
Divorced/Widowed	1 (10%)	2 (25%)	1 (20%)	3 (42.8%)	7 (23.3%)
Highest Education (N, %)
High School or less	3 (30%)	4 (50%)	0	3 (42.8%)	10 (33.3%)
Beyond high school	7 (70%)	4 (50%)	5 (100%)	4 (57.1%)	20 (66.6%)
Household Income (N, %)
<$50,000	9 (90%)	8 (100%)	2 (40%)	4 (57.1%)	23 (76.6%)
≥$50,000	1 (10%)	0	3 (60%)	3 (42.8%)	7 (23.3%)
# E-cig uses/day (M, SD)	29.30 (24.21)	72.88 (80.64)	29.00 (15.17)	23.57 (34.51)	39.53 (49.53)
Vape continuously all day (N,%)	6 (60%)	7 (87.5%)	4 (80%)	6 (85.7%)	23 (76.6%)
Disposable device (N, %)	4 (40%)	3 (37.5%)	1 (20%)	3 (42.8%)	11 (36.6%)
Nicotine Content (N, %)a
<50mg/ml, 5%	2 (20%)	4 (50%)	1 (20%)	3 (42.8%)	10 (33.3%)
≥50mg/ml, 5%	7 (70%)	4 (50%)	4 (80%)	4 (57.1%)	20 (66.6%)
Flavor (N, %)
Tobacco/Menthol	5 (50%)	3 (37.5%)	2 (40%)	5 (71.4%)	15 (50%)
Fruit/Other	5 (60%)	5 (62.5%)	3 (60%)	2 (28.5%)	15 (50%)
Past e-cig quit attempt (N,%)	6 (60%)	3 (37.5%)	3 (60%)	6 (85.7%)	18 (60%)
Former Smokers (N, %)	6 (60%)	-	2 (40%)	-	8/15 (53.3%)
# Smoking days/week (M, SD)b	6 (2)	4 (3)	6 (2)	5 (3)	-
Cigarettes per day (N, %)b					-
0–10	3 (50%)	7 (87.5%)	1 (50%)	5 (71.4%)
11–20	2 (33.3%)	0	1 (50%)	1 (14.2%)
21+	1 (16.6%)	1 (12.5%)	0	1 (14.2%)
Time to first cigarette (N, %)b					-
≤5 minutes	2 (33.3%)	3 (37.5%)	0	4 (57.1%)
>6 minutes	4 (66.6%)	5 (62.5%)	2 (100%)	3 (42.8%)
WISDM total score (M, SD)	50.10 (12.89)	52.81 (8.14)	37.93 (15.19)	46.93 (15.04)	48.06 (13.11)
ECDI total score (M, SD)	14.40 (4.48)	14.88 (3.64)	11.60 (5.37)	13.43 (3.74)	13.83 (4.19)
VCQ (M, SD)
Negative Consequences	5.59 (1.96)	5.72 (2.80)	4.40 (2.71)	5.93 (1.72)	5.51 (2.23)
Positive Reinforcement	5.36 (1.91)	5.85 (2.06)	3.56 (2.51)	5.89 (1.94)	5.31 (2.12)
Negative Reinforcement	6.16 (1.87)	6.20 (1.82)	5.00 (1.82)	6.27 (1.78)	6.00 (1.79)
Weight Control	6.56 (1.27)	2.00 (4.80)	4.80 (2.33)	5.97 (1.63)	5.95 (1.77)

Notes:

^amissing data due to response of “don’t know.”

^bNs/% in “e-cigarette only” columns reflect former smokers, who were asked about the past.

3.2. Qualitative Interviews

Table 2 provides themes and sample quotations from interviews (n=28; two interviews were unable to be transcribed). In response to “Tell me about why you are interested in quitting e-cigarettes (and cigarettes, if applicable)”, major themes emerged surrounding health, cost, perceptions of friends and family, negative consequences of dependence, and stigma. All (n=28) participants acknowledged that there were detrimental effects of vaping on health, largely related to nicotine exposure and unknown long-term effects. Dual users had substantial health concerns regarding the known effects of cigarette smoking and the potential additive effects of vaping. Many (n=19) also noted that cost was a motivating factor to quit, and some participants suggested the financial costs were comparable to cigarette smoking. Disapproval from friends and family were also highly motivating for participants (n=17). Many discussed feeling the need to hide their e-cigarette use from others and negative consequences once loved ones found out. Many (n=19) participants endorsed discontent with being dependent on e-cigarettes, noting that they find themselves using more than desired and not being in control of their vaping. Finally, n=22 participants discussed repercussions from stigma associated with vaping. Some individuals (n=8) endorsed problems at work as a result of continued e-cigarette use.

Table 2.

Interview themes and sample quotes

Prompt	Theme	Quotes
“Tell me about why you are interested in quitting e-cigarettes (and cigarettes, if applicable)”	Health	“I’m interested in quitting because of health concerns that I know that it is damaging to my body. The area where I notice it the most is my lung capacity and my ability to exercise is limited. And I think that would benefit hugely from finding a way to quit.” 28-year-old white male, mono user “Just the concept of like sucking out a device and blowing it. And I’m the same way. I mean it’s just gross. And you’re inhaling it, and I know what’s in it. And I just know that it’s unhealthy. And I’m in the medical field, so I know how bad it is. I tell my patients not to do it, and I go and do it…I have acne from it. I have a sensitivity to the propylene glycol, and so I get like cystic acne. I’ve been having hair loss since I started it. Obviously with COVID, the susceptibility and the whole popcorn lung and everything. I just know that it’s really bad, and then obviously like the flavorings and stuff.”28-year-old white female, former smoker “I thought it was an alternative to try to quit smoking as much nicotine, but they make me cough a lot. It’s like they make my chest hurt sometimes.” 28-year-old white female dual user
	Cost	“I thought it was gonna be cheaper, but in all actuality I’m still spending - so it’s $20.00 for my refills, and I’m still spending that four times a week sometimes. That’s a lot; it’s not cheaper” 37-year-old white female, former smoker “And the financial aspect, you know, it’s a pretty useless thing to be spending money on.”26-year-old white male, former smoker
	Family/Friends	“And if my family knew that I did it, they’d be like ashamed. And I know that my husband hates it, and he’s thrown out my device several times. And we have arguments about it. And so I have to do it in like private, so it’s like a shameful thing for me to do.” 28-year-old white female, former smoker “My parents begged, begged, begged me to quit” 22-year-old white female, mono user
	Dependence	“[After quitting smoking], instead of like what you’re supposed to do, go down in nicotine and try to wean yourself off, I literally stayed at the same one…I think I vape more than I smoked cigarettes” 32-year-old white female, former smoker “I don’t want to be dependent on any cigarettes or e-cigarettes.” 49-year-old Hispanic male, dual user
	Stigma	“And that’s kind of what got me in trouble at work. I kind of hide the JUUL, but I was puffing away on that and there’s a lot more smoke with it and the boss saw it and he wasn’t too happy. You know, I said, ‘I don’t want to lose this job. It’s a beautiful job,’ and it’s like, ‘Why do I keep doing that?’” 58-year-old white female, dual user
“Have you talked to a medical professional about your e-cigarette use? What was that like/what do you think it would be like?”	Stigma	“They just didn’t really like – they didn’t care as much which was what made me feel weird about it. They didn’t really want to refer any hotlines or anything… they didn’t really provide any help, they just said you should quit.” 23-year-old Hispanic female, mono user “I kind of like didn’t tell them how much I was smoking… the doctor was really hard on me about the vape. He said that they are really worse than cigarettes, like, cigarettes are bad too, but he was telling me that a vape is really, really bad.”28-year-old white female, dual user
	Support	“She’s not a fan of any kind of nicotine use at all but at least this was a start headed in the right direction, so she kind of basically left it right there. She was like ‘Oh, I’m glad. I’m glad you’ve taken a pathway to want to quit completely.’ So, that’s how she left it”. 50-year-old Black male, former smoker “The doctor that I talked to when I asked about Chantix, she was very understanding. She wasn’t judgmental. I felt comfortable. I imagine I wouldn’t with all doctors, but she was pretty chill.” 33-year-old South Asian male, former smoker
	Ambivalence	“They all ask you when you first go in, you know, ‘Do you drink? Do you smoke? Do you do this or that?’ And I mean it really doesn’t go farther than just telling that I used to smoke and now I vape. It really hasn’t gone farther, and honestly I really haven’t had any health concerns that would make me need anyone’s guidance on that.”30 year-old Native American female, former smoker
“What do you think the challenges will be when quitting e-cigarettes (and smoking)?”	Accessibility	“The cost and the convenience. I save a lot of money using this as opposed to smoking cigarettes. This is really affordable…This is accepted in restaurants or in stores. I can just vape away and nothing is said. So, I’m not breaking any laws.” 50-year-old Black male, former smoker
	Social situations	“I believe the biggest challenge will probably be just having to not be around [my girlfriend] when she does it. I’ll let her know, ‘If you’re going to do it, make sure you’re away from me and I don’t see you do it, because I don’t want to watch you do something that I really want to do.’” 20-year-old white male, former smoker
	Mood	“Just the thought of not having it. It’s been such a crutch my whole life. Whenever I’m stressed out or anxious, even if it doesn’t really make me feel better, I guess I’m tricking myself, like a placebo type effect. It’s just like a security blanket to me.” 27-year-old white male, dual user
	Sensorimotor/Habit	“I think I kind of have less of a nicotine problem and more of a mouth fixation problem…Like, I go to hit something all of the time. It’s like something I do in between activities, like, I feel like it’s going to be hard for me to like shake that.”21-year-old white female, dual user
	Withdrawal	“[When I’ve stopped vaping in the past] I was ungodly agitated and irritable. And everything bothered me. And my mood was just really bad. And I was tired, and I had body aches. I was sweating at night. It was really bad.” 28-year-old white female, mono user

When asked “Have you talked to a medical professional about your e-cigarette use? What was that like/what do you think it would be like?”, participants reported mixed feelings about the encounters. Some (n=13) reported that their healthcare providers had negative viewpoints about e-cigarette use and felt admonished after disclosing their vaping. On the other hand, others (n=9) reported that their doctors were supportive of their e-cigarette use if it was a means to reduce cigarette smoking.

Participants were asked “What do you think the challenges will be when quitting e-cigarettes (and smoking)?” Major themes that emerged included habitual and sensorimotor factors, social situations, nicotine withdrawal, mood symptoms, and convenience. Many participants (n=17) endorsed that e-cigarette use was a habit embedded into their everyday activities, noting that the sensorimotor aspects of vaping felt automatic. Participants described feeling discomfort when being without their e-cigarette (n=17), some (n=15) endorsing mood symptoms such as anxiety or stress. Participants (n=18) also reported that being around others who vape would pose a challenge when trying to quit. Some individuals (n=17) described withdrawal symptoms from previous times when they were without e-cigarettes or had tried to quit vaping, similar to cigarette withdrawal: headaches, nausea, irritability, anxiety, and sleep disturbance. Dual users reported a similar concern regarding their dependence on nicotine from both products. Finally, participants (n=10) noted that the ease of accessibility and use of e-cigarettes would make it hard to break the habit.

3.3. Feasibility and Acceptability

Participants in the intervention group completed, on average, 19.61 daily surveys (SD = 8.63) throughout the 28-day treatment (70.0%). Within these survey responses, participants reported using NRT an average of 12.78 days (SD=10.14; patch M = 10.89 days [SD=9.98]; lozenges M= 6.39 days [SD=7.11]; combined use M = 4.50 days [SD=6.40]). Participants reported few days with adverse side effects from the NRT (M=2.67, SD=4.99). A majority of participants completed the EOT survey (80%) and a large number completed the FU survey (66.6%). Those with missing data had vaping and smoking status imputed as not abstinent. These results are shown by intervention group in Table 3.

Table 3.

Abstinence outcomes

	Intervention (N=18)			Control (N=12)			Intervention vs Control Fisher, p, φ
	E-cigarette only (N=10)	Dual Use (N=8)	Overall	E-cigarette only (N=5)	Dual User (N=7)	Overall
End of Treatment (Day 28)
Completed survey	8 (80%)	5 (62.5%)	13 (72.2%)	4 (90%)	7 (100%)	11 (91.6%)	-
E-cigarette abstinencea	4 (40%)	2 (25%)	6 (33.33%)	0	0	0	5.00, .057, −.408
E-cigarette change							5.22, .087, .416
Reduced	2 (33.3%)	3 (50%)	5 (41.7%)	1 (20%)	3 (42.8%)	4 (33.3%)
No change	4 (66.7%)	3 (50%)	7 (58.3%	4 (80%)	4 (57.1%)	8 (66.7%)
Increased	0	0	0	0	0	0
Smoking abstinencea	-	0	0	-	0	0	-
Smoking change							1.85, .498, .237
Reduced	0	1 (12.5%)	1 (6.6%)	0	1 (14.2%)	1 (6.7%)
No change	10 (100%)	7 (87.5%)	17 (94.4%)	5 (100%)	5 (71.4%)	10 (83.3%
Increased	0	0	0	0	1 (14.2%)	1 (6.7%)
Intervention Group b
# surveys completed	21.00 (6.15)	17.88 (11.23)	19.61 (8.63)	-	-	-	-
# days vapingc	6.50 (8.29)	6.88 (8.32)	6.67 (8.06)	-	-	-	-
# days smokingc	.10 (.32)	6.63 (10.53)	3.00 (7.54)	-	-	-	-
# days attempting to quit vapingc	18.10 (8.43)	12.25 (10.42)	9.30 (10.64)	-	-	-	-
# days attempting to quit smokingc	-	3.75 (7.42)	1.03 (4.01)	-	-	-	-
# days using any NRTc	15.20 (9.58)	9.75 (10.63)	12.78 (10.14)	-	-	-	-
# days using NRT patchc	12.50 (9.37)	8.87 (10.99)	10.89 (9.98)	-	-	-	-
# days using NRT lozengec	7.20 (9.37)	8.87 (10.99)	6.39 (7.11)	-	-	-	-
# days using combined NRTc	4.50 (5.16)	4.50 (8.07)	4.50 (6.40)	-	-	-	-
# days endorsing AEc	4.50 (6.20)	.38 (.52)	2.67 (4.99)	-	-	-	-
Follow-up (Day 56)
Completed survey	8 (80%)	4 (50%)	12 (66.6%)	3 (60%)	5 (71.4%)	8 (66.6%)	-
E-cigarette abstinencea	3 (30%)	2 (25%)	5 (27.78%)	1 (20%)	1 (14.2%)	2 (16.66%)	.49, .669, −.129
E-cigarette change							1.63, .547, .239
Reduced	3 (30%)	2 (33.3%)	5 (41.6%)	0	4 (57.1%)	4 (33.3%)
No change	4 (40%)	4 (66.7%)	8 (61.5%)	4 (80%)	3 (42.8%)	7 (63.6%)
Increased	0	0	0	0	0	0
Smoking abstinencea	-	0	0	-	0	0	-
Smoking change							1.88, .416, .247
Reduced	0	2 (25%)	2 (11.1%)	0	2 (28.5%)	2 (16.7%)
No change	10 (100%)	6 (75%)	16 (88.9%)	5 (100%)	4 (57.1%)	9 (75%)
Increased	0	0	0	0	1 (14.2%)	1 (6.7%)

Notes:

^a7-day point-prevalence via self-report.

^bNo significant differences were found between smoking status on these variables.

^cAmong responders only.

3.4. Abstinence Outcomes

Table 3 shows abstinence outcomes by group, with non-responders imputed as not abstinent. Among those in the intervention group, 6 (33.3%) reported abstinence from vaping at EOT, whereas 0 participants in the control group endorsed abstinence (Fisher statistic = 5.00, p=.057, φ = −.408). At FU, 5 participants (27.7%; 4/6 that were abstinent at EOT) in the intervention group remained abstinent from vaping whereas 2 (16.66%) in the control group endorsed quitting vaping. Within those who continued to vape at EOT and FU, 5 participants in the treatment group (5/12; 41.67%) and 4 participants in the control group (33.33%) endorsed reducing e-cigarette use. Among dual users, no participants in either treatment group reported abstinence from cigarettes at either endpoint. At EOT, 2 participants had reduced smoking (13.3%) and 1 increased (6.6%). At follow-up, 4 reduced smoking (26.67%) and 1 increased (6.67%). Importantly, no mono users endorsed initiating or returning to cigarette smoking.

Table 4 shows differences in self-reported treatment engagement and outcomes between those who quit vaping and those who did not. Participants in the intervention group who quit vaping reported making an active quit attempt on significantly more days (M=23.17, SD=3.31) than those who did not quit (M=5.83, SD=8.81, t=−7.70, p<.001). Those who quit also reported significantly more days using NRT (M=22.66, SD=2.87; patches [M=19.50, SD=4.76]; lozenges [M=11.33, SD=7.06] than those who did not quit (NRT days M=7.83, SD=8.67, t=−5.36, p<.001; patch days M=6.58, SD=9.11, t=−3.23, p<.001; lozenge days M=3.91, SD=5.96, t=−2.34, p<.05). Table 4 also shows vaping outcomes crossed with smoking outcomes among those with dual use, former smoking, and never smoking histories. No dual users who quit e-cigarettes had increased their smoking at either EOT or FU.

Table 4.

Smoking outcomes and treatment effects by e-cigarette abstinence

	E-cigarette Abstinence
EOT (Day 28)	Abstinent (N=6)	Not abstinent (N=24)	Abstinent vs Not T or Fisher, p, d or φ
Smoking change			2.01, .501, .217
Reduced	1	1
No change	5	22
Increased	0	1
Intervention (N=18)	Abstinent (N=6)	Not abstinent (N=12)
# e-cigarette quit attempt daysa	23.16 (3.31)	11.66 (9.37)	−3.8, <.001, −1.44
# days using any NRTa	22.67 (2.88)	7.83 (8.67)	−5.36, <.001, −2.01
# days using NRT patcha	19.50 (4.76)	6.58 (4.76)	−3.23, <.01, −1.61
# days using NRT lozengea	11.33 (7.06)	3.91 (5.96)	−2.35, <.05, −1.17
# days using combined NRTa	8.16 (6.49)	2.66 (5.75)	−1.83, .08, −0.92
Follow-up (Day 56)	Abstinent (N=7)	Not abstinent (23)
Smoking change			2.27, .416, .261
Reduced	2	2
No change	5	20
Increased	0	1

	E-cigarette Change
Smoking Change Categorized by Smoking History	Quit	Reduced	No change	Increased
Dual Use
Reduced	1	3	0	0
No change	1	2	7	0
Increased	0	1	0	0
Former Smoking
Reduced	0	0	0	0
No change	2	1	5	0
Increased	0	0	0	0
Never Smoking
Reduced	0	0	0	0
No change	2	2	3	0
Increased	0	0	0	0

Notes:

^aAmong responders only.

4.0. DISCUSSION

This preliminary clinical trial sought to evaluate 1) interest and motivations for vaping cessation among adults, and 2) the feasibility and acceptability of NRT alongside a supportive booklet for e-cigarette cessation among mono- and dual-user adults motivated to quit. The small sample recruited for this pilot study presents clear limitations that reduce the generalizability and interpretability of the results. However, given the lack of empirically supported interventions for e-cigarette cessations, especially among adults and dual users, these data represent an important exploratory contribution that can guide future treatment interventions.

As a measure of feasibility, a large number of individuals in the community expressed interest in the study over the short course of study duration. This is especially significant in that equal numbers of dual users and e-cigarette only users, including former cigarette smokers, were recruited. This demonstrates that these individuals are in need of treatment interventions to support nicotine cessation. The remote procedures were an advantage for recruitment, allowing participants to complete all study visits from where they were located, which increased reach and representativeness in the sample. Once enrolled, a majority engaged in the treatment and completed the follow-up surveys. Overall, these findings add support to the nascent body of work being conducted to develop, test, and disseminate effective e-cigarette cessation treatments. On the other hand, results are somewhat suggestive of survey response burden for those in the intervention group. At EOT 92% (11/12) of control participants responded to the survey, whereas only 72.2% (13/18) of intervention participants responded. It should be noted that these measures may better represent feasibility of a cessation trial and may not fully capture feasibility of engaging in the intervention. Future trials should be designed with more rigorous feasibility assessment in mind, which will aid dissemination of treatments.

Consistent with previous literature^4,5,8–18, participants discussed several negative consequences of vaping that motivated them to seek treatment. Namely, acute and distal health concerns, dependence, social stigma, and cost. Many of these factors overlap with negative consequences of cigarette smoking. This evidence is encouraging in that the overlap of motivational factors for quitting smoking may also be applied to e-cigarette and dual use cessation treatments. The combined negative consequences from dual product use may be especially salient to encourage users to completely quit nicotine. Finally, motivational enhancement strategies might be able to capitalize on these negative outcomes to promote e-cigarette cessation among those who may be experiencing some of these consequences of vaping.

Another important finding from the qualitative analysis was that participants reported mixed messages from healthcare providers about quitting vaping. This might be a result of the different smoking histories that participants presented to their providers with. That is, there is no standard set of recommendations available to providers who are presented with patients at various stages of the tobacco use spectrum. Participants also discussed a number of barriers and challenges related to quitting vaping, including withdrawal symptoms, changes in mood, sensorimotor habits, and convenience. Overall, these results show that there are several treatment gaps to be filled. To begin, treatment interventions and consistent cessation guidelines should be rapidly disseminated to a variety of providers in the healthcare system, as this is a typical starting point for many seeking assistance with tobacco use. Future intervention studies should attempt to mitigate some of the barriers to quitting by addressing physiological and habitual factors that maintain continued e-cigarette use.

This preliminary intervention trial provides further insight into the effectiveness of NRT to promote e-cigarette cessation^23,25,26. In the sample recruited, a substantial proportion of e-cigarette only users who endorsed use of the provided NRT were able to quit mono-vaping. This suggests that NRT might be sufficient to mitigate nicotine withdrawal symptoms in e-cigarette users quitting, which is a bit surprising given the relative inefficiency of NRT to deliver nicotine as compared to e-cigarettes. However, when considering NRT’s efficacy for combustible tobacco cessation, these results are consistent. NRT was clearly insufficient for dual users seeking to quit both vaping and smoking, suggesting that dual users have unique pharmacologic needs and/or non-pharmacologic constructs should be addressed more substantially. More research is needed to determine 1) pharmacotherapy recommendations for e-cigarette cessation and 2) the most effective treatment protocol for dual users. Importantly, individuals who quit vaping did not increase or initiate cigarette smoking at follow-up, which helps to alleviate concerns regarding relapse or increases in smoking during e-cigarette cessation. Although some participants in the dual use group reduced smoking alongside vaping, most did not change their smoking. Given the high disease burden of combustible tobacco use, quitting smoking should remain a top priority.

4.1. Limitations

Results should be interpreted with caution given the pilot nature of the study, minimal intervention, single variable tests, and short-term follow-up period. The NRT dose was not tailored for each individual, and thus, may have been insufficient to address those with greater dependence, including dual users. Additionally, engagement with the treatment outside from NRT (e.g., support booklet, quitline) was not evaluated and should be a priority for future research studies. Survey contact may have also augmented quit intentions in the intervention group. Because the purpose of the study was to evaluate the feasibility and acceptability of NRT alongside a supportive booklet, the control group did not complete daily surveys. Therefore, important information regarding the nature of the quit attempts in this group is lacking. Finally, reliance on self-reported abstinence and imputing missing data has limitations³⁶, although biochemical verification of e-cigarette use separate from NRT is challenging³⁹.

4.2. Conclusions

Recruitment for the present study supports that many adults are interested in e-cigarette or dual use cessation. Participants reported experiencing negative consequences from vaping that motivated them to quit but received minimal support for overcoming challenges associated with quitting. This preliminary trial of NRT + a self-help booklet for e-cigarette cessation showed encouraging evidence of effectiveness for those who use e-cigarettes only. Future research should confirm these results through larger, more rigorous trials, and explore ways to improve outcomes for dual users. Effective interventions should be rapidly disseminated to treatment providers to assist the growing number of e-cigarette users who wish to quit.

Highlights.

• Many adults who use e-cigarettes are interested in quitting

• Interventions for e-cigarette cessation are not well studied

• Participants were interested in quitting due to negative effects of dependence

• Nicotine replacement therapy for vaping cessation was feasible and acceptable

• Larger trials should evaluate nicotine replacement therapy for vaping cessation