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. Author manuscript; available in PMC: 2025 Feb 1.
Published in final edited form as: Exp Clin Psychopharmacol. 2023 Mar 13;32(1):16–26. doi: 10.1037/pha0000644

Development of Two Novel Treatments to Promote Smoking Cessation: Savor and Retrieval Extinction Training Pilot Clinical Trial Findings

Amanda M Palmer 1, Matthew J Carpenter 1,2,3, Nathaniel L Baker 1, Brett Froeliger 5,6, Madeline G Foster 3, Eric L Garland 7,8, Michael E Saladin 2,4, Benjamin A Toll 1,2,3
PMCID: PMC10497721  NIHMSID: NIHMS1887992  PMID: 36913266

Introduction:

Despite decades of progress, cigarette smoking remains a significant contributor to disease burden. This effect is especially pronounced for specific priority populations, such as individuals who live in rural communities, in that the burden of tobacco smoking is greater among these groups than in urban areas and the general population. The present study aims to evaluate the feasibility and acceptability of two novel tobacco treatment interventions delivered through remote telehealth procedures to individuals who smoke in the state of South Carolina. Results also include exploratory analyses of smoking cessation outcomes. Study I evaluated Savoring, a strategy based in mindfulness practices, alongside nicotine replacement therapy (NRT). Study II evaluated retrieval extinction training (RET), a memory-modification paradigm alongside NRT. In Study I (Savoring), recruitment and retention data showed high interest and engagement in the intervention components, and participants who received this intervention decreased cigarette smoking throughout the course of the treatment (ps <.05). In Study II (RET), results showed high interest and moderate engagement in treatment; although exploratory outcome analyses did not demonstrate significant treatment effects on smoking behaviors. Overall, both studies showed promise in generating interest among individuals who smoke in participating in remotely delivered, telehealth smoking cessation interventions with novel therapeutic targets. A brief Savoring intervention appeared to have effects on cigarette smoking throughout treatment whereas RET did not. Gaining insight from the present pilot study, future studies may improve the efficacy of these procedures and incorporate the treatment components into more robust available treatments.

Keywords: smoking cessation, savoring, mindfulness, retrieval extinction training (RET), remote trial

Introduction

Although tobacco use has significantly declined over the past few decades in the US, there remains significant disparities in tobacco use rates among various subpopulations (US Department of Health & Human Services, 2014). Regions of the US that have the greatest health and policy disparities tend to also have the highest cigarette smoking rates, i.e., the south, Midwest, and rural areas (Cornelius et al., 2022). These areas have high cigarette smoking rates (21–27% compared to the national average of about 15%) accompanied by higher incidence and mortality from lung cancer (Jenkins et al., 2018), other cancers (Hartwell et al., 2016; Li et al., 2020), cardiac disease, chronic lung diseases, and stroke (Garcia et al., 2017). The primary causes of this are twofold: 1) Currently available treatments are not effective for the remaining individuals who continue to smoke, and 2) Existing and effective treatments are inaccessible to those who smoke (Brady, 2020). These alarming trends demonstrate a critical need for the development and broad dissemination of novel yet effective tobacco treatment interventions into these rural and underserved areas.

Pharmacological treatments are an appropriate mainstay of tobacco treatment. These include nicotine replacement therapy (NRT), bupropion, and varenicline, all of which are available in the US to individuals over the age of 18 (whereas tobacco cannot be sold to those under 21). Research shows that pharmacologic treatments work best alongside behavioral counseling (Stead et al., 2016). However, clinical practice guidelines for behavioral approaches to tobacco treatment have had minimal advancement over the past 20 years (Fiore, 2009). Among these, cognitive-behavioral therapy (CBT) strategies have empirical support, as they address smoking via stimulus control, coping with urges and withdrawal symptoms, behavioral substitution, and relapse prevention. However, modest effectiveness of these strategies suggest that CBT may be insufficient in addressing all mechanisms that might maintain smoking behaviors (Vinci, 2020). There is clear benefit to development of novel, non-pharmacological cessation interventions.

Another barrier to promoting smoking cessation is limited access to treatment resources. Geographic distance and lack of transportation to healthcare settings prevent the receipt of evidence-based treatment (Arcury et al., 2005; Douthit et al., 2015). Even within community and healthcare centers, physician adherence to USPHS guidelines for smoking cessation (i.e., 5As) is inconsistent (Kruger et al., 2015; Kruger et al., 2016). Recent estimates from surveys show that most individuals who visited a health professional do not receive adequate advice to quit smoking (Schaer et al., 2021; Vijayaraghavan et al., 2017). Additional options for individuals who cannot access treatment are limited. One resource for all individuals who smoke is the national/state Quitline, which offers free, evidence-based cessation support (Borland & Segan, 2006; Zhu, 2000). However, Quitlines reach only a very small portion (~1% nationally) of the smoking population (Boland et al., 2019). Overall, attempts to treat individuals who smoke in healthcare facilities and via Quitlines make minimal impact on reaching those who have the greatest need for services.

To overcome barriers related to inadequate treatment mechanisms and poor treatment reach, we present results from 2 separate pilot trials of 2 new treatments targeting novel mechanisms: 1) reward processing deficits associated with nicotine use; and 2) memory for nicotine reinforced learning. Importantly, testing novel behavioral interventions is a critical component of eliminating tobacco related disparities by providing more treatment options for those who have had minimal success with existing treatments. Each trial was delivered using remote study procedures to increase access to these treatments (Dahne et al., 2020). The primary aims were to evaluate the feasibility and accessibility of these treatments delivered using telehealth to individuals living in South Carolina, a state with high smoking prevalence and a large rural population (Eberth et al., 2018). The results of this proof-of-concept study will provide early encouraging findings related to the utility of two remotely delivered, novel behavioral treatments, alongside other empirically supported remote interventions (i.e., NRT).

Transparency

The sample sizes for these pilot studies were based on time and budget constraints. As with pilots, these sample sizes provide the ability to create reliable effect size estimates to determine power analyses for a large scale randomized clinical trial (Rounsaville et al., 2001). We report all data exclusions, all manipulations, and all measures in each study. Analyses were conducted using SPSS v27 and SAS v9.4. The studies’ design and analysis were not pre-registered. Materials and analysis code for this study are available by emailing the corresponding author. This study was approved by the Medical University of South Carolina Institutional Review Board.

Study I: Savoring

Background

A key characteristic of substance use disorders is the development of maladaptive reward processing, which presents as an imbalance between cues associated with substance use rewards and cues associated with non-substance rewards (Diggs et al., 2013; Volkow & Morales, 2015). That is, intrinsic non-substance reward cues lose their salience among individuals with substance use disorder, which is problematic as these rewards are available during periods of abstinence and may offset the drive to seek substance-related rewards (Garland, 2021). CBT is often the first line treatment for tobacco cessation; however, most CBT skills do not sufficiently address this reward imbalance, and rather focus on behavioral substitution and stimulus control.

Mindfulness strategies, on the other hand, have shown promise in restructuring reward processes (Froeliger et al., 2017; Garland, 2021; Garland, Atchley, et al., 2019; Garland et al., 2021; Garland et al., 2014; Garland et al., 2016). Mindfulness Oriented Recovery Enhancement (MORE) (Garland, 2013) has demonstrated efficacy for treating opioid misuse and other addictive behaviors (Garland et al., 2022) and has been shown to increase the neural processing of non-substance rewards (Froeliger et al., 2017; Garland, Atchley, et al., 2019; Garland et al., 2021; Garland et al., 2014). A key component of MORE is a skill called Savoring, during which an individual focuses mindful awareness on the pleasant sensory features of a positive object or event as well as the positive emotions and pleasurable body sensations occasioned by that experience (Bryant & Veroff, 2017; Garland, 2020). Preliminary investigations of Savoring among individuals who smoke have demonstrated increases in corticostriatal reward circuitry response to natural reward cues coupled with decreased response in corticostriatal circuitry to cigarette cues (Froeliger et al., 2017). In Study I, we adapted the Savoring technique from MORE into a brief intervention to be used in tandem with NRT for remote delivery to individuals who smoke.

Methods

Recruitment and Participants.

Online advertisements were placed seeking approximately 40 individuals who were interested in quitting smoking from September 2020 to April 2021. Advertisements specified that the study required no in-person visits and provided a link to an online screening survey. Eligibility criteria included the following: 1) age 18+; 2) daily smoking (25+ days per previous month); 3) smoking 5+ cigarettes/day; 4) smoking >1yr; 5) some interest in quitting smoking within the next month (>2 on 10-point scale); 6) own a smartphone or have daily access to email, and 7) live in South Carolina.

Study Procedures.

Eligible participants provided electronic consent (REDCap; Harris et al., 2009)] over phone or through a virtual video visit (Doxy.me) and completed baseline assessments. Participants were then randomized to the Savor or Control conditions, stratified by baseline cigarettes per day (CPD; ≤15 or >15). All participants were scheduled for an initial phone call or video visit with a counselor (a clinical psychologist) to review study procedures and receive their respective intervention. Following the completion of this phone call, participants were mailed a 14-day supply of 21mg nicotine patches. All participants were then sent daily surveys (via email or text) for 28 days following the completion of the initial phone call.

Interventions.

Savor.

Participants assigned to the Savor intervention had a visit (phone or synchronous video) with a counselor and were asked to choose an object of importance that draws out positive emotions (e.g., photo of a loved one, sentimental trinket). Participants were guided through a 10-minute practice of Savoring that included a brief period of mindfulness to stabilize attention, followed by a focusing of awareness on the sensory experience of the object while attending to any positive emotions or pleasurable sensations arising during the experience (Garland, 2020). Afterwards, the counselor debriefed the participant’s experience of savoring using the same processing approach employed in MORE. This approach (Garland, Hanley, et al., 2019) involves phenomenological exploration of positive emotions, sensation, and states of consciousness; utilization of learning to foster future change (i.e., smoking cessation); reframing challenges during practice as success; educating on the process of savoring to build positive expectancies; and providing positive reinforcement for practice engagement. Participants were provided with an MP3 file of the counselor guiding a Savoring exercise and were asked to engage in 15 minutes/day of Savoring practice on their own. Three days following this initial phone call, participants were re-contacted by the counselor for a second session of practicing Savor and processing as outlined above. This reinforced the self-guided Savoring practice, and the counselor helped to troubleshoot any problems that had arisen. Both sessions lasted 15–20 minutes.

Control.

Participants in the control condition were contacted by a counselor to review study procedures, provide instructions for NRT use, and answer any questions.

Measures.

After consent, participants completed questions on demographics, smoking history, and current smoking. Participant zip codes were matched using the Health Resources & Human Services Administration (HRSA) rural zip code database to determine if participants lived in a rural area (Health Resources and Human Services Administration (HRSA), 2022). Daily surveys assessed cigarettes smoked per day (CPD), patch use (yes/no), quit attempts (yes/no), cravings [4-items (Carter & Tiffany, 2001)], Savoring practice (yes/no), minutes Savored on days practiced, satisfaction with Savoring (0–10; 0=not at all, 10=enjoyable), and mood (0=very negative – 10=very positive). Reduction in CPD was calculated by subtracting the average CPD throughout treatment from baseline CPD.

Compensation.

Participants in both groups were compensated up to $60 in electronic gift cards for daily survey completion ($10 minimum for 1 survey, $60 for 26–28 surveys). Participants in the Savor group received $25 at the completion of the first and second training telephone calls, and $25 for each of 2 days for self-reported practice of the exercise between the first and second call.

Outcomes.

Feasibility was assessed by 1) the number of participants who enrolled and 2) the number of daily surveys completed. Acceptability was assessed by self-reported practice of Savoring, satisfaction with Savoring, and uptake of NRT use. Abstinence at Day 28 was determined by self-reported 3-day point prevalence (no biochemical confirmation). Given the very short time period of both treatment and follow-up, we felt that 3-day point prevalence was the most parsimonious choice for an outcome with these preliminary data.

Analysis.

Participants who were randomized but did not engage in baseline procedures related to the intervention (e.g. the initial call with the counselor) were excluded from analysis (i.e. randomized non-starters), and missing data were coded as smoking (not abstinent) or no attempt to quit or reduce smoking (modified intent-to-treat [ITT]; Gupta, 2011). Descriptive statistics were used to evaluate feasibility and acceptability outcomes. End of treatment abstinence outcomes were assessed utilizing a modified Poisson approach (Zou, 2004) and presented as the relative risk (RR) of abstinence and associated 95% confidence interval (CI) between study treatment assignments. Between group comparisons of other variables (number of quit attempts, CPD reduction) were compared using t-tests, with an emphasis on effect sizes. Mixed effects regression models evaluated the effects of treatment condition and time on daily measurements of smoked cigarettes, cravings to smoke, and subjective mood. To assess the linear effect of these variables over time, study day was examined as a continuous factor in all secondary analysis. Further treatment by time interactions were assessed to determine if treatment effects varied over the duration of study treatment.

Results

Participant demographics can be seen in Table 1.

Table 1.

Demographics

Study I Study II
Savor
N=19		 Control
N=20		 P RET
N= 19		 Control
N= 15		 P
Age (M, [SD]) 43 (13) 39 (12) .32 43 (12) 45 (13) .64
Biological sex (N,
%)		 Male
Female		 7 (36.8%)
12 (63.2%)		 8 (40%)
12 (60%)		 .84 12 (63.2%)
7 (36.8%)		 9 (60%)
6 (40%)		 .85
Race (N, %) Asian
Black/African
American
White
More than one		 0
1 (5.3%)
18 (94.7%)
0		 1 (5%)
4 (20%)
14 (70%)
1 (5%)		 -- 0
5 (26.3%)
13 (68.4%)
1 (5.3%)		 0
1 (6.7%)
13 (86.7%)
1 (6.7%)		 --
Ethnicity (N, %) Latine
Non-Latine		 2 (10.5%)
17 (89.5%)		 1 (5%)
19 (95%)		 .52 1 (5.3%)
18 (94.7%)		 1 (6.7%)
14 (93.3%)		 .86
Education (N, %) Less than
bachelors
Bachelors or more		 15 (78.9%)
4 (21.1%)		 13 (65%)
7 (35%)		 .33 14 (77.8%)
4 (22.2%)		 9 (60%)
6 (40%)		 .27
Income (N, %) Under $50k
$50k or
higher		 12 (63.2%)
5 (26.3%)		 15 (75%)
2 (10%)		 .20 15 (78.9%)
4 (21.1%)		 13 (86.7%)
2 (13.3%)		 .56
Region (N, %) Rural
Not Rural		 2 (10.5%)
17 (89.5%)		 1 (5%)
19 (95%)		 .52 0
18 (100%)		 1 (6.7%)
14 (93.3%)		 --
Cigarettes per day (M, [SD]) 19.22
(11.74)		 14.83
(6.82)		 .16 17.05
(5.89)		 19.44
(9.91)		 .39
Time to first cigarette (N, %) Within 5 mins Later 10 (52.6%)
9 (47.4%)		 6 (30%)
14 (70%)		 .15 7 (63.2%)
12 (36.8%)		 6 (40%)
9 (60%)		 .85
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Note: Study II, RET group characteristics only include participants who watched at least one video (19/25; see Table 2). Region refers to HRSA defined rural zip code (Health Resources and Human Services Administration (HRSA), 2022). P-values represent results from chi-square or t-test analyses comparing demographics between treatment groups (chi-square tests could not be calculated when cells=0).

Feasibility and Acceptability.

Feasibility and acceptability outcomes are in Table 2. In response to online advertisements, 416 individuals completed the screening survey, 268 (64.4%) of whom did not meet eligibility criteria and 49 (11.8%) of whom were uninterested in participating. Of the 99 eligible and interested, 44 (44.4%) were able to be contacted and consented into the study. Of those consented, 39 (88.6%) completed the initial baseline phone calls and are used in the analytic sample (n=19 Savor, n=20 Control). Only one Savor participant missed the second call. Overall, participants completed M=24.4 (SD=5.4; 87.1%) of the 28 daily surveys throughout the course of treatment.

Table 2.

Feasibility and Acceptability Outcomes

Study I (Savor) Study II (RET)
Feasibility
Responded to advertisements (N) 416 453
Eligible and interested (n, %) 99 (23.8%) 119 (26.3%)
 Consented (n, % eligible, interested) 44 (44.4%) 54 (45.4%)
Completed baseline call (enrolled)
Intervention (n)
Control (n)		 39 (88.6%)
19
20		 40 (74.1%)
25
15
Daily surveys completed (0–28; M, SD) 24.4 (5.41) 23.52 (8.57)
Acceptability
Intervention engagement Days Savored (0–28; M, SD)
Minutes Savored per day (9.7–102.3; M, SD)
Satisfaction (0–10; M, SD)		 23.21 (4.43)
29.9 (22.82)
7.77 (1.41)		 Watched >90% of either video
   Video 1
   Video 2
   Both		 19 (76%)
18 (69%)
15 (57%)
14 (54%)
Patch use days Intervention (0–28; M, SD)
Control (0–28; M, SD)		 14.53 (5.37)
9.70 (7.60)		 Intervention (0–28; M, SD)
Control (0–28; M, SD)		 10.84 (7.44)
3.93 (6.75)
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Note: Study II outcomes of daily surveys completed and patch use only include participants who watched at least one video.

Participants in the Savor group endorsed engaging in the Savor practice for M=23.2 days throughout the 28-day treatment period and reported an average of 29.9 (SD=22.8) minutes of Savoring per day of practice. Among those who practiced Savoring, the average satisfaction rating was 7.77/10 (SD=1.41). Participants in the Savor group endorsed using the NRT patches on M=14.53 (SD=5.37) days, whereas those in the Control group reported patch use M=9.70 (SD=7.60) days.

Abstinence, CPD, Cravings, and Mood.

Abstinence outcomes are shown in Table 3. Participants in the Savor group endorsed making a quit attempt on significantly more days (M=22.16, SD=3.86) than those in the Control group (M=13.30, SD=8.33; t=4.29, p<.01, d=−1.35) and had a significantly greater reduction in CPD from baseline to end of treatment (M=10.02, SD=8.88) than those in the control group (M=4.27, SD=3.98; t=2.63, p<.05, d=−1.35). A numerically higher number of participants in the Savor group self-reported 3-day point-prevalence abstinence at EOT (5/19; 26.3%) than the control group (2/20, 10.0%; RR=2.20 [95%CI: 0.49 – 9.74]).

Table 3.

Abstinence Outcomes

Study I (Savor) Study II (RET)
Savor
N=19		 Control
N=20		 Statistic RET
N= 19		 Control
N= 15		 Statistic
# days endorsing quit attempt (M, SD) 22.16 (3.86) 13.30
(8.33)		 t=4.29
p<.01
d= 1.35 		15.68 (8.49) 14.80 (9.74) t=.28
p=.78
d=.09
Reduction in CPD (M, SD) 10.02 (8.88) 4.27 (3.98) t= 2.63
p<.05
d = 1.35 		5.94 (5.23) 7.06 (9.27) t=.45
p=.65
d=.15
3-day PP abstinence (N, %) 5 (29.4%) 2 (10%) RR = 2.20
(95%CI: 0.49 – 9.74)		 8 (44.4%) 3 (20%) RR= 1.94
(95%CI: 0.61 – 6.24)
Mixed Models
Study I (Savor) Study II (RET)
Outcome CPD Cravings Mood CPD Cravings
Treatment (relative to control) ß = −0.38
p = .82		 ß = 0.78
p = .43		 ß = 0.21
p = 0.66		 ß = −0.76
p = .61		 ß = −.56
p = .65
Time ß = 0.04
p = .09		 ß = −0.07
p < .001 		ß = 0.004
p = 0.17		 ß = −0.23
p <.001 		ß = −0.10
p <.001
Treatment X Time ß = −0.25
p<.05 		ß = −0.11
p = .054		 ß = 0.03
p = .30		 ß = −0.03
p = .83		 ß = −.05
p = .48
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Note: Bolded outcomes indicate p <. 05.

When evaluating the effect of study day on CPD, cravings to smoke, and mood, controlling for baseline CPD (Figure 1A), analyses showed that there was a significant interaction effect of treatment and time on CPD such that the Savoring group smoked less over time (β=−0.25, p<.05). Across both treatment groups, study day was associated with reductions in cravings (β=−0.07, p<.0001). There was also a smaller interaction effect of treatment X time on cravings such that the Savor group showed steeper reduction cravings relative to Control (β=−0.11, p=.054). The effects of treatment and treatment X time interaction on mood were not statistically significant.

Figure 1.

Figure 1

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Note: Models controlled for baseline CPD. Y y-axis shows the predicted outcome score from the mixed models. Treatment lines and shaded regions show the 95% confidence intervals

Study II: Retrieval Extinction Training (RET)

Background

Associative learning accounts of addictive behavior posit that repeated pairings between cues and drug rewards result in formerly neutral cues controlling a range of conditioned behaviors (e.g., craving, urges) that subserve initiation and maintenance of drug seeking, procurement and ingestion (Bevins & Palmatier, 2004). In the case of cigarette smoking, environmental cues (e.g., sight of preferred brand of cigarettes, etc.) that repeatedly co-occur with smoking become associated with the rewarding effects of nicotine (Shiffman, 1993). By extension, learning accounts posit that exposure-based treatment, which involve repeated exposure to the cues in the absence of nicotine reward (AKA, cue exposure therapy) result in the development of an inhibitory learning processes (i.e., extinction) that enters into a competitive relationship with the original learned associations, thereby attenuating the ability of the cues to elicit responses (e.g., craving) that maintain smoking behavior (Unrod et al., 2014). While cue exposure-based interventions have demonstrated some modest treatment utility, they are hampered by several limitations that result in the re-emergence of the original nicotine reinforced learning (Carter & Tiffany, 1999, 2001; Conklin & Tiffany, 2002). Specifically, the behaviors tend to re-emerge with the passage of time (i.e., spontaneous recovery), when conditioned cues occur in novel contexts (i.e., renewal) or following any occurrence of drug use/smoking (i.e., reinstatement). Importantly, recent developments in memory research have been leveraged to create a potentially more effective behavioral strategy to address the learning-based causal elements of addiction. A growing body of translational neuroscience research shows that memories for prior learning can be modified by retrieving the memories and behaviorally altering/updating them before they are reconsolidated into long-term storage (Luo et al., 2015; Paulus et al., 2019). This well-developed body of literature has amply documented that these altered/updated memories no longer exert the behavioral control they once did, thereby revealing a potential new strategy for abating the effects of drug-reinforced learning.

Retrieval-Extinction Training (RET; Monfils et al., 2009; Schiller et al., 2010) is a strategy that, while distinct from extinction, employs extinction procedures to alter the memories of prior learning (rather than rely on the competitive action of independent inhibitory learning processes as noted above). Procedurally, RET first involves a brief memory retrieval procedure involving presentations of cues involved in the original learning, which serves to destabilize the target memories. After a brief rest period, protracted extinction training is performed, which serves to update the original memories with information that is contrary to the original training (i.e., that reinforcement no longer co-occur with the cues). RET has been shown to reduce cue-elicited craving in individuals who use heroin (Xue et al., 2012), and, more recently, among individuals who smoke (Germeroth et al., 2017). In the latter study, these changes were accompanied by reductions in cigarette smoking behavior itself. To extend these findings, we modified the RET intervention for remote delivery to individuals who smoke and combined it with NRT. Unlike Study I (which provided NRT to both groups), Study II provided NRT to the RET group alone.

Methods

Recruitment and Participants.

Online advertisements were placed from July 2021 to May 2022 seeking approximately 40 individuals who were interested in quitting smoking and linked to an electronic screener (similar to Study I). Eligibility criteria included the following: 1) age 18+; 2) daily smoking (25+ days per previous month); 3) smoking 5+ cigarettes/day; 4) smoking >1yr; 5) some interest in quitting within the next month (>2 on 10-point scale); 6) willing to go 2 days without smoking, unassisted; 7) own a smartphone or have daily access to email, and 8) live in South Carolina.

Study Procedures.

Eligible participants provided electronic consent (REDCap; Harris et al., 2009)) over the phone or through a virtual video visit (Doxy.me) and completed baseline assessments. Participants were then randomized to the RET or Control conditions at a 2:1 ratio, respectively, stratified by baseline CPD (≤10 or >10). All participants were scheduled for an initial phone call or video visit with a counselor (clinical psychologist) to review study procedures and receive their respective intervention. All participants were then sent daily surveys (via email or text) for 28 days following the completion of the initial phone call.

Interventions.

RET.

Participants assigned to the RET group were asked to engage in 2 days of RET training session via pre-recorded videos while remaining abstinent from smoking. Participants were each sent two nearly identical 82-minute videos 24 hours apart. Video software captured objective metrics of video engagement: number of minutes, and pauses using established methods (Wistia®). Following the initial phone call, participants were mailed a 14-day supply of NRT patches and were instructed to use them after the 2nd training session.

The videos were guided by a licensed psychologist, who provided a brief introduction to the training. Video clips and image cues used were previously validated (Tong et al., 2007). Next, participants watched a 5-minute smoking video that served as the retrieval cue to putatively initiate the memory destabilization. The retrieval video included high-resolution video segments of individuals of both sexes engaging in smoking related behaviors (e.g., lighting up a cigarette and smoking). After a 10-minute rest period, 4 stimulus sequences (15-minutes each, totaling 1 hour of stimulus exposure) were presented, each of which consisted of counterbalanced orders of 5-minute video, picture, and in-vivo smoking cues. The video cues were the same as the videos that served as the retrieval cues. The picture cues were a series of 30 validated pictures of smoking-related images (people smoking, cigarette packages, etc.). The in-vivo cues were a guided procedure in which participants were instructed to manipulate their preferred brand of cigarettes and a lighter (i.e., visually inspect, smell, feel the cigarettes, and flick the lighter). They were explicitly instructed not to light any of the cigarettes. At the end of the second video training session, use of the NRT was reviewed.

Control.

Participants in the control group were provided with information regarding the SC Quitline, including the ability to receive NRT from the Quitline as the study did not provide patches. Participants were provided with phone, text, email, and web contact information to arrange services with the Quitline.

Measures.

Study II used the same measures as Study I.

Compensation.

Participants in both groups were compensated up to $60 in electronic gift cards for daily survey completion (same schedule as Study I). Participants in the RET group received an additional $75 for completion of the initial phone call with the counselor and both video training sessions.

Outcomes.

The same feasibility and self-reported abstinence-related outcomes were used as Study I. Acceptability was assessed by engagement with the RET video sessions (percent of each video watched).

Analysis.

The same analytic strategy as Study I was used, including a modified ITT strategy that excluded treatment non-starters in the RET group (i.e., participants who did not watch at least 10% or more of the RET videos were treated as randomized non-starters and excluded from all analyses; like drug trials in which participants must take at least one dose to be considered as engaging in the study treatment).

Results

Participant demographics can be seen in Table 1.

Feasibility and Acceptability.

Feasibility and acceptability outcomes are in Table 2. In response to online advertisements, 453 individuals completed the screening survey, 261 (57.6%) of whom did not meet eligibility criteria and 73 (16.1%) of whom were uninterested in participating. Of the 119 eligible and interested, 54 (45.4%) were able to be contacted and consented into the study. Of those consented, 43 (79.6%) completed the baseline phone call and enrolled (n=28 RET, n=15 Control). One participant withdrew after enrollment and 1 was found to be fraudulent (n=26 remaining in RET).

Included in the intervention analyses are n=19 (73%) participants who watched at least 10% of either video (treatment initiators). Overall adherence was moderate: n=18 (69%) watched the first video (n=15 watched 82 minutes, the remainder watched 73–81 minutes); n=15 (57%) watched the second video (n=12 watched 82 minutes, the remainder watched 49–80 minutes); n=14 (54%) watched both videos. Within both treatment groups, participants completed M=23.52 (SD=8.6; 84%) of daily surveys throughout the 28-day treatment period. Participants in the RET group endorsed using the NRT patches (provided by the study) on M=10.84 (SD=7.4) days, whereas those in the Control group (no patches provided) reported patch use M=3.93 (SD=6.7) days.

Abstinence, CPD, and Cravings.

Abstinence outcomes are shown in Table 3. There were no significant differences between participants in the RET group and Control group on number of days endorsed making a quit or reduction in CPD throughout treatment. A higher number of participants in the RET group self-reported 3-day point-prevalence abstinence at EOT (8/18; 44.4%) than the Control group (3/15, 20%; RR = 1.94 [95%CI: 0.61 – 6.24]).

When evaluating the effect of study day on CPD and cravings to smoke, controlling for baseline CPD (Figure 1b). No significant effects of treatment or treatment X time interaction emerged on CPD or cravings. Across both treatment groups, time was associated with reductions in CPD (β=−.23, p<.001) and cravings (β=−.10, p<.001).

Discussion: Studies I and II

Smoking cessation continues to offer strong impact on public health outcomes and improving overall quality of life. Critical to such efforts is the availability, accessibility, and effectiveness of smoking cessation interventions for all individuals, especially those who have been historically underserved (Cornelius et al., 2022; Fiore, 2009). The purpose of the present study was to evaluate the feasibility, acceptability, and preliminary outcomes of pilot trials of 2 novel behavioral treatment mechanisms delivered through remote telehealth procedures (Dahne et al., 2020). Such novel treatment mechanisms are an important component for research, as they can augment support in existing remote intervention procedures (e.g., NRT). Interventions included Savoring, a mindfulness technique used to increase salience of non-drug rewards, and RET, a paradigm that seeks to alter memories that are critical to the maintenance of drug use behaviors. Both interventions recruited participants from South Carolina, a state that is largely rural and has higher smoking rates that the US average (Eberth et al., 2018). These studies aimed to recruit a sample representative of South Carolina. A majority of our participants resided in non-rural areas, which is not entirely representative of the state and is likely a result of advertising in online forums rooted in metropolitan areas. Future trials should use advertising and recruitment methods that reach rural populations more directly. Because of procedural differences between the 2 studies, we caution against cross-study (Savor vs RET) comparisons. Additionally, small sample sizes, attrition, and missing data all limit the interpretability of the analyses.

As evidenced by recruitment and enrollment data, the number of individuals interested in smoking cessation was high, despite minimal use of advertising. Study samples were generally representative of the area. It may be that the opportunity to try novel treatment mechanisms was attractive to participants, who may have had only cursory experience with more traditional modalities for quitting smoking. This demonstrates that when offered novel treatments, individuals who smoke will be highly interested and remote procedures may facilitate treatment delivery (Dahne et al., 2020). However, despite high numbers of individuals interested in quitting smoking through the research study, rates of enrollment into each study decreased substantially. While this is not unusual for such trials, the eligibility criteria should be considered. Participants were only required to have moderate interest in quitting (>2/10) which could have impacted our recruitment rate and results by initially attracting high numbers of interested individuals but losing those who were not motivated enough to continue. Ability to engage with study procedures may have posed additional barriers for our recruited sample (Hutcheson et al., 2008). For instance, participants in our study required internet access and mobile phone use (data, texting), and access to these services might have been limited due to geographic location or financial barriers. Another postulation is that study procedures (e.g., phone calls, watching videos) may have been limited by occupational or other domestic responsibilities. Future research of telehealth procedures with rural populations should seek to address potential barriers to participation, by either offering additional resources (e.g., cell phone with data service activated) or providing flexibility (e.g., staff available to make calls outside of traditional work hours). Data from this study show that once enrolled into the study, response rates to daily surveys was high. This shows promise for future research that seeks to collect data daily over an extended period, which provides opportunities for rich analyses. Due to the pilot nature of the studies, no a priori feasibility or acceptability benchmarks were set; however, these data provide insight into aspirational criteria for future work.

In general, engagement with the Savor intervention among enrolled participants was high. This may be due to the flexibility of the intervention, as participants were encouraged to practice the skill on their own time and were provided with an audio file that could be accessed as needed. The intervention also had high satisfaction ratings, which may have contributed to the observed engagement. Interestingly, Savor participants reported higher instances of using the provided NRT patches as compared to the control group within Study I which also received patches, suggestive of carryover effects for aspects of engagement with other related treatment mechanisms. Although strong conclusions cannot be drawn from these pilot data, results are suggestive of promise of Savoring as an intervention component that may improve motivation to quit (as evidenced by increased patch use) and decrease cigarette smoking among individuals who want to quit. Savor can be incorporated into existing behavioral tobacco cessation treatment protocols as a standalone skill, perhaps with an accompanying audio recording as was done with this pilot. Alternatively, interventions that focus on the Savor skill exclusively, or a MORE protocol adapted for smoking cessation, may show promise in engaging individuals in tobacco cessation.

This study was not designed to draw comparative conclusions between the Savor and RET interventions; however, it is worth noting that the RET intervention had markedly less engagement with the intervention components. There are several reasons that may explain this effect. The RET procedures were quite time-intensive at the start of the intervention, requiring participants to watch an 82-minute video, 2 days in a row. Although this procedure has excellent foundational efficacy data when performed in the laboratory, an intensive procedure such as this may not translate to self-administration. Future studies may develop and evaluate different ways to deliver the RET treatment procedures in a manner that is less burdensome or more time-flexible. Additionally, participants were asked to abstain from smoking during the RET video session days. This is easier to control and verify in a lab environment as compared to participants’ own environment. Future trials of RET may consider adding additional behavioral support for these treatment session days to encourage engagement and abstinence. It is promising that in this pilot study, participants who watched the videos generally watched at least one in entirety. Additionally, participants in the RET condition used the NRT more. More work is needed to understand what aspects facilitated engagement with these participants, and what barriers existed for participants who did not complete the RET sessions.

An important aspect of both interventions to consider is that neither study required participants to select a quit day per se. Participants expressed nominal interest in quitting smoking, completed intervention components at scheduled times, and were provided with NRT; however, they did not develop a structured, scheduled quit day plan. Despite this, participants who received the Savor interventions reduced cigarette smoking over the study period. Future research can attempt to bolster outcomes for both interventions by including these intervention components within a more robust, structured smoking cessation intervention that includes committing to a quit day (Fiore, 2009).

Limitations

Many of the limitations of the present study are due to the pilot nature of each intervention. In addition, these studies relied on self-report of abstinence which may not capture sufficient abstinence data, although there is good evidence that self-reported abstinence does not substantially differ from biochemically confirmed data (Murray et al., 2002). Future research should capitalize on remote biochemical data collection procedures when possible (Dahne et al., 2020; Thrul et al., 2022). Whereas in Study I (Savor) the treatment mechanism was able to be evaluated (i.e., measuring mood and satisfaction), the same could not be done in Study II (RET). Future research on RET might explore measures of treatment processes. Along similar lines, both the Savor and RET intervention groups received more contact throughout the study, and subsequently, more study compensation. Doing so was beneficial for the aims of this pilot study; however, future research studies should be mindful to achieve more contact and compensation balance between groups so that these factors do not confound the results. Using ITT in the analyses has limitations that should also be considered (Gupta, 2011), especially since we used a modified ITT approach among participants who initiated treatment only (e.g. randomized non-starters and those who did not engage in treatment were not included).

Although these limitations limit the interpretability of the clinical outcomes of interest, the primary aim of the study was to evaluate feasibility and acceptability to understand how intervention procedures might be modified in future studies to increase engagement, maintain retention, and reduce attrition. Future research may include larger sample sizes that are more generalizable and provide sufficient power to assess abstinence-related outcomes, as well as evaluate sociodemographic differences in engagement and response to treatment for future intervention tailoring.

Conclusions

Addressing tobacco use with effective, cutting edge-interventions among populations with high smoking prevalence and low access to treatment options is a priority for public health (US Department of Health & Human Services, 2014). The present study separately evaluated the feasibility and acceptability of 2 novel treatment mechanisms, Savor and RET, delivered via remote procedures and telehealth to individuals interested in quitting smoking in South Carolina. Results demonstrated high interest in quitting smoking and early signals of efficacy for these 2 novel treatments. Future research should investigate fully powered clinical trials for these novel tobacco treatment interventions.

Public Health Significance.

The current pilot study tested the engagement and outcomes of telehealth delivery of two new behavioral treatments for tobacco use, Savoring and Retrieval Extinction Training (RET), alongside nicotine replacement therapy. There was high interest and engagement in Savoring which reduced smoking, and there was moderate engagement in RET with minimal effect on smoking. Savoring and RET should continue to be studied and integrated into tobacco treatment protocols.

Disclosures and Acknowledgements

This work was supported by the National Institutes of Health (grant numbers T32HL144470, P30CA138313, 5R01DA043587. All authors have contributed to the manuscript and have read and approved the final version. BAT testifies on behalf of plaintiffs who have filed litigation against the tobacco industry. All other authors have no additional disclosures.

Footnotes

The studies’ design and analysis were not pre-registered. Materials and analysis code for this study are available by emailing the corresponding author.

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