Investigating Alexithymia as a Moderator of Outcomes in a Randomized Controlled Trial of an Online Intervention for Co-Occurring Depression and Hazardous Alcohol Use: Enquête sur l'alexithymie en tant que modérateur des résultats dans un essai randomisé contrôlé d'une intervention en ligne pour la dépression concomitante et la consommation dangereuse d'alcool.

OBJECTIVE: Alexithymia is characterized by difficulty identifying and/or describing emotions, reduced imaginal processes, and externally oriented thinking. High levels of alexithymia may increase the challenge of supporting individuals with co-occurring depression and hazardous alcohol use. This secondary analysis sought to investigate whether or not alexithymia moderated the outcomes of an online intervention for depression and alcohol use. METHOD: As part of a randomized controlled trial, 988 participants were randomly assigned to receive an intervention dually focused on depression and alcohol use, or an intervention only focused on depression. The pre-specified mediation hypothesis was that changes in drinking at 3 months follow-up would effect the association between the intervention and change in depression at 6 months. This secondary analysis extends the investigation by adding alexithymia as a moderator. RESULTS: The current analysis demonstrated that including alexithymia as a moderator resulted in a conditional direct effect. Specifically, there was an intervention effect where participants who received the combined depression and alcohol intervention had larger improvements in their depression scores at 6 months, but this was only when their alexithymia score at baseline was also high (60.5 or higher). CONCLUSION: These results suggest that treatment planning and intervention effectiveness could be informed and optimized by taking alexithymia severity into consideration. This is especially merited as alexithymia can contribute to the weaker therapeutic alliance, more distress and dysphoria, shorter periods of abstinence, and more severe depression, compounding the complexity of supporting individuals with comorbid conditions. More research is needed to systematically investigate these possible modifying effects. PLAIN LANGUAGE TITLE: Does difficulty identifying/describing emotions or externally-oriented thinking influence the effectiveness of an intervention among people with both depression and hazardous alcohol use?

In a recent study we recruited participants who were concerned with both their alcohol use and low mood. We provided two different online interventions. Half of the participants received an intervention designed for both concerns and half received an intervention that addressed only depression. We hypothesized that receiving the combined intervention for both concerns would result in greater benefits, however, our results indicated no apparent difference. This analysis uses the same data, but investigated the influences of alexithymia on the effectiveness of the interventions. Alexithymia is defined as having difficulty identifying/describing emotions and/or thinking more about external events than internal feelings. It commonly co-occurs with depression and with hazardous alcohol use and can increase the challenge of supporting individuals with these co-occurring concerns. The results of this analysis showed support for our original hypothesis that participants who received the intervention that addressed both their mood and alcohol concerns had lower depression scores 6-months later, but only among individuals who also had alexithymia scores above 60.5. Taking alexithymia severity into consideration during treatment planning may help optimize the effectiveness of interventions. These results show merit for future research to consider alexithymia as a variable that could potentially impact outcomes among individuals with co-occurring depression and hazardous alcohol use.

Patterns of remission from alcohol dependence in the United Kingdom: results from an online panel general population survey.

BACKGROUND: Previous research has demonstrated that remissions from alcohol use disorders can occur without accessing treatment. The current study explored the prevalence of such untreated remissions in the UK and further, examined the extent to which people who resolved an alcohol use disorder regarded themselves as ever, or currently, being in recovery. METHODS: Participants were recruited using the Prolific online platform. Participants who met criteria for lifetime alcohol dependence (ICD-10) were asked about their drinking at its heaviest, use of treatment services, whether they identified as being in recovery, and their current alcohol consumption (to identify those who were abstinent or drinking in a moderate fashion). RESULTS: A total of 3,994 participants completed surveys to identify 166 participants with lifetime alcohol dependence who were currently abstinent (n = 67) or drinking in a moderate fashion (n = 99). Participants who were currently abstinent were more likely to have accessed treatment than those who were currently moderate drinkers (44.4% versus 16.0%; Fischer's exact test = 0.001). Further, those who were abstinent were heavier drinkers prior to remission [Mean (SD) drinks per week = 53.6 (31.7) versus 29.1 (21.7); t-test = 5.6, 118.7 df, p < .001] and were more likely to have ever identified themselves as 'in recovery' (51.5% versus 18.9%; Fischer's exact test = 0.001) than current moderate drinkers. CONCLUSIONS: While participants with an abstinent remission were more likely than those currently drinking in a moderate fashion to have accessed treatment and to identify as being 'in recovery,' the majority of participants reduced their drinking without treatment (and did not regard themselves as in recovery).

Remaining Between the Cracks - The Long-Term Effect of Different Suicide Risk Exclusion Criterion on Outcomes of an Online Intervention for Depression.

Background: Previous studies have demonstrated that excluding individuals at risk of suicide from online depression interventions can impact recruited sample characteristics. Aim: To determine if a small change in suicide risk exclusion criterion led to differences in the usage and effectiveness of an Internet depression intervention at 6 months of follow-up. Method: A partial sample of a recently completed online depression intervention trial was divided into two groups: those with no risk of suicide versus those with some risk. The two groups were compared for baseline demographic and clinical measures, as well as intervention uptake and treatment success across 6 months. Results: Overall, individuals with less risk of suicide at baseline reported significantly less severe clinical symptoms. Both groups interacted with the intervention at the same rate, but specific use of modules was different. Finally, the impact of intervention usage on outcomes over time did not vary by group. Limitations: While different suicide risk exclusion criteria can change recruited sample characteristics, it remains unclear how these differences impact intervention uptake and success. Conclusion: Overall, the findings suggest that researchers should exercise caution when excluding individuals at risk of suicide, as they greatly benefit from web-based interventions.

Examining Changes in Quality of Life as an Outcome Measure in Three Randomized Controlled Trials of Online Interventions That Included an Intervention for Hazardous Alcohol Use.

BACKGROUND: Quality of life (QOL) summarizes an individual's perceived satisfaction across multiple life domains. Many factors can impact this measure, but research has demonstrated that individuals with addictions, physical, and mental health concerns tend to score lower than general population samples. While QOL is often important to individuals, it is rarely used by researchers as an outcome measure when evaluating treatment efficacy. METHODS: This secondary analysis used data collected during three separate randomized controlled trials testing the efficacy of different online interventions to explore change in QOL over time between treatment conditions. The first project was concerned with only alcohol interventions. The other two combined either a gambling or mental health intervention with a brief alcohol intervention. Males and females were analyzed separately. RESULTS: This analysis found treatment effects among female participants in two projects. In the project only concerning alcohol, female quality of life improved more among those who received an extensive intervention for hazardous alcohol use compared to a brief intervention (p = .029). QOL among females who received only the mental health intervention improved more than those who also received a brief alcohol intervention (p = .049). CONCLUSION: Poor QOL is often cited as a reason individuals decide to make behavior changes, yet treatment evaluations do not typically consider this patient-important outcome. This analysis found some support for different treatment effects on QOL scores in studies involving at least one intervention for hazardous alcohol use.

Effect of Postal-Mailed Nicotine Patches on Tobacco Cessation Among Smokers in Rural Canada: A Randomized Clinical Trial.

This randomized clinical trial assesses the efficacy of mailed nicotine patches on cessation of tobacco smoking among adults in rural Canada.

Normative Misperceptions About Cannabis Use in a Sample of Risky Cannabis Users.

Introduction: This study examines normative misperceptions in a sample of participants recruited for a brief intervention trial targeting risky cannabis use. Methods: Participants who were concerned about their own risky cannabis use were recruited to help develop and evaluate intervention materials. At baseline, participants reported on their own cannabis use and provided estimates of how often others their gender and age used cannabis in the past 3 months. Comparisons were made between participants estimates of others cannabis use with reports of cannabis use obtained from a general population survey conducted during a similar time period. Results: Participants (N = 744, mean age = 35.8, 56.2% identified as female) largely reported daily or almost daily cannabis use (82.4%). Roughly half (55.3%) of participants estimated that others their age and gender used cannabis weekly or more often in the past 3 months, whereas the majority of people in the general population reported not using cannabis at all. Conclusions: Normative misperceptions about cannabis use were common in this sample of people with risky cannabis use. Limitations and possible future directions of this research are discussed, as well as the potential for targeting these misperceptions in interventions designed to motivate reductions in cannabis use. ClinicalTrialsorg number: NCT04060602.

Learning to quit: can reinforcement theories predict the success of smoking cessation attempts using nicotine replacement therapy patches in a general population sample of smokers at 8-weeks and 6-months follow-up?

Primary, secondary, and tertiary reinforcement contribute to the maintenance of smoking behaviour and may influence the efficacy of different cessation treatments. This analysis examined these relationships in a large general population sample and investigated how previous experiences of the different reinforcement mechanisms impacted future quit attempts. Random digit telephone dialing was used to recruit a sample of Canadian adults who smoked and were interested in being part of a hypothetical program that would provide nicotine replacement therapy (NRT) patches free by mail and half of the eligible participants were randomized to actually receive a five-week supply of NRT patches. During the interviews, reasons for relapse to smoking during previous quit attempts were collected and coded by two reviewers (disagreements were settled by a third reviewer). Binary logistic regression was used to determine if type of reinforcer moderated the intervention effect of the patches. Participants who made cessation attempts in the past year were more likely to report negative (p = .039), secondary (p = .041), and tertiary (p = .010) reinforcers and less likely to report positive reinforcers (p = .016) compared to those who did not attempt to quit. Logistic regressions revealed no significant conditional effects of the intervention on the relationship between reinforcer type and quit attempts or 30-day smoking abstinence. Analysis including all three reinforcers showed negative reinforcers decreased but tertiary reinforcers increased the odds participants reported a cessation attempt before the baseline interview and between baseline and 8-weeks. Understanding the different ways nicotine reinforces smoking behaviour could help guide individuals to more effective treatment options.

An analysis of cannabis home cultivation and associated risks in Canada, before and after legalization.

Background: In 2018, Canada legalized the use and sale of non-medical cannabis, with most provinces also permitting home cultivation. To advance the knowledge of home cultivation patterns in Canada within the context of legalization, this study examines (1) the demographics and use patterns of cannabis home growers before and after legalization and (2) the relationship between home cultivation and cannabis-related risks, including workplace use and driving after cannabis use(DACU). Data and methods: The study is based on seven waves of the National Cannabis Survey, dating from 2018 to 2019. Descriptive statistics were used to analyze home cultivation across several individual and sociodemographic characteristics pre- and post-legalization. Logistic regression was used to examine whether home cultivation is correlated to selected cannabis-related risks. Results: The rate and demographics of home cultivation remained relatively unchanged post-legalization. Those most likely to cultivate cannabis post-legalization were male; 35 years and older; not single; married, common law, divorced, separated or widowed; lived in the Atlantic provinces; consumed cannabis medically or medically and non-medically on a daily or almost daily basis; had more than a high school diploma; and reported "smoking" as their primary consumption method. Home cultivation was correlated to workplace use but not to DACU. Interpretation: The research provides early insights into home cultivation within a legalized framework. It also shows a relationship between home cultivation and certain cannabis-related risks (e.g., workplace use), suggesting a need for future research to determine whether tailored education and policy interventions are needed to target cannabis home growers.

Examining the influence of rurality on frequency of cannabis use and severity of consequences as moderated by age and gender.

AIM: A number of important health disparities associated with place of residence have been reported in the literature. The Remoteness Index (RI) was developed to account for community size, population density, and proximity to larger population centres. This exploratory analysis uses the RI to examine community level associations related to cannabis use. DESIGN: This secondary analysis uses data collected as part of a randomized controlled trial of a brief cannabis intervention. Participants' place of residence was matched to a corresponding value on the RI. Univariate regressions of RI and cannabis related outcomes were modeled with age and gender as moderating variables. Three outcomes were analyzed separately: 1) total number of days of cannabis use in the past 30 days; 2) risk of experiencing cannabis related problems; and 3) number of self-reported consequences related to cannabis. FINDINGS: Participants living in more remote areas were significantly more likely to drive within an hour of using cannabis, but also reported fewer consequences and less risky cannabis use. Although the overall regression models tested in the moderation analyses were significant, there were no interaction effects between RI and age or gender. CONCLUSION: While this analysis did not find significant conditional effects of age or gender on the relationship between cannabis use and place of residence, further research is needed to investigate other factors which may contribute to health disparities related to substance use between individuals living in different geographic regions.

Using a consistency check during data collection to identify invalid responding in an online cannabis screening survey.

BACKGROUND: Inconsistent responding is a type of invalid responding, which occurs on self-report surveys and threatens the reliability and validity of study results. This secondary analysis evaluated the utility of identifying inconsistent responses as a real-time, direct method to improve quality during data collection for an Internet-based RCT. METHODS: The cannabis subscale of the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) was administered as part of eligibility screening for the RCT. Following the consent procedure, the cannabis subscale was repeated during the baseline interview. Responses were automatically compared and individuals with inconsistent responses were screened out. RESULTS: Nearly half of those initially eligible for the RCT were subsequently screened out for data quality issues (n = 626, 45.3%). Between-group bivariate analysis found that those screened out (OUT) were significantly older (OUT = 39.5 years (SD = 13.9), IN = 35.7 years (SD = 12.9), p < .001), more had annual incomes less than $20,000CND (OUT = 58.3%, IN = 53.0%, p = .047), used cannabis less often in the past 30 days (OUT = 23.3 days (SD = 9.7), IN = 24.8 days (SD = 11.3), p < .006), and had lower total ASSIST scores at screener (OUT = 19.3 (SD = 8.0), IN = 23.8 (SD = 10.4), p < .001) and baseline (OUT = 17.5 (SD = 7.9), IN = 23.3 (SD = 10.3), p < .001) compared to participants who were screened in to the RCT. CONCLUSION: Inconsistent responding may occur at high rates in Internet research and direct methods to identify invalid responses are needed. Comparing responses for consistency can be programmed in Internet surveys to automatically screen participants during recruitment and reduce the need for post-hoc data cleaning.

Randomized controlled trial of online interventions for co-occurring depression and hazardous alcohol consumption: Primary outcome results.

BACKGROUND AND AIMS: The current trial tested the benefits of offering a brief online intervention for hazardous alcohol consumption along with one for depression among people experiencing both conditions. METHODS: Online advertisements were used to recruit people with persistent low mood. Those who also had current hazardous alcohol consumption were identified and invited to take part in the trial (those not eligible were offered access to the online depression intervention). Participants were randomized to an established intervention for depression (MoodGYM; M-only) or to receive MoodGYM plus a brief personalized feedback intervention for hazardous drinking (Check Your Drinking; M + CYD). Participants were followed-up at three and six months. RESULTS: While levels of depression symptoms (p < .001) and hazardous alcohol consumption (p < .001) reduced in both the M-only and the M + CYD groups, there was no difference between groups on drinking (p = .374) or depression outcomes (p = .752). Further, participants who were provided both interventions logged into the intervention website less often (M = 4.1, SD = 3.9) compared to participants only offered the depression intervention (M = 4.9, SD = 5.2), t (986) = 2.47, p = .014. However, there was no significant difference (p > .05) in the number of MoodGYM modules completed between the two groups. DISCUSSION AND CONCLUSION: The current trial found no benefit to providing a brief online intervention for hazardous alcohol consumption alongside one for depression among people experiencing these co-occurring disorders. Further, the finding that adding an online intervention for drinking to one for depression led to a small reduction in the number of times the interventions were accessed implies the need for caution when deciding how best to provide online help to those with co-occurring depression and hazardous alcohol consumption.Trial Registration: ClinicalTrials.govNCT03421080.

Online personalized feedback intervention to reduce risky cannabis use. Randomized controlled trial.

BACKGROUND AND AIMS: Given the widespread use of cannabis, and the concomitant risks associated with the drug, there is a need to increase the availability of interventions designed to reduce risky cannabis use. One promising intervention in the addictions employs personalized normative feedback to motivate change. METHODS: A two-arm randomized controlled trial (RCT) was conducted in which participants who used cannabis in a risky fashion were randomly assigned to one of two groups - those who received an online personalized feedback report in addition to educational materials about risky cannabis use and those who just received the online educational materials. Follow-up assessment occurred at three- and six-months post-randomization. Outcome variables included: number of days cannabis was used in the past 30, risky cannabis use (ASSIST score of four or more), and participant estimates of the proportion of cannabis users among those of the same age and gender. RESULTS: A total of 744 participants with risky cannabis use were recruited for the trial using online advertisements. There were no significant differences between intervention and educational materials only groups at three- and six-month follow-ups for the outcome variables, number of days used cannabis in the last 30 (p = 0.927) and proportion of participants engaging in risky cannabis use (p = 0.557). At three and six month follow-ups, participants who received the feedback intervention were more likely than those in the educational materials group to estimate that a larger proportion of people their age and gender did not use cannabis in the last year (p = 0.028). DISCUSSION AND CONCLUSION: While there was some evidence that the personalized feedback intervention modified normative perceptions about cannabis use, there did not appear to be support for the prediction that the intervention reduced cannabis consumption.

Falling between the cracks: The effect of using different levels of suicide risk exclusion criteria on sample characteristics when recruiting for an online intervention for depression.

BACKGROUND: Despite a strong link between suicide risk and depression, a recent literature review found that many effectiveness studies for online depression interventions exclude individuals at risk of suicide. This study scrutinizes how different suicide risk exclusion criteria impact recruitment rates and final sample characteristics. MATERIALS AND METHODS: Two recruitment periods for an online depression intervention trial utilized different suicide risk cutoff exclusion criteria, a one-point difference on the last item of the Personal Health Questionnaire (i.e., more than 0 (Not at all) vs. more than 1 (Several Days)). Bivariate statistics were used to assess differences in recruitment rates and sample characteristics between these two recruitment periods, while all other eligibility criteria and recruitment strategies remained consistent. RESULTS: The recruitment period using the least restrictive suicide risk exclusion criteria yielded twice as many participants; however, recruited sample characteristics did not significantly differ among demographic or clinical characteristics, despite observable trends. DISCUSSION: Researchers should carefully select suicide risk exclusion criteria that balance recruitment rates, study budgets, and sample selection biases, while minimizing participant harm. Moreover, researchers are urged to report suicide risk exclusion rates and consider these exclusions when interpreting results. Limitations of the results are also discussed.

Offering nicotine patches to all households in a community with high smoking rates: Pilot test of a population-based approach to promote tobacco cessation.

BACKGROUND: The objective of this project is to determine the effectiveness of targeting a community with a high smoking rate with the distribution of free-of-charge nicotine patches in order to promote tobacco cessation. METHODS/DESIGN: One small community with an elevated smoking rate (compared to national and provincial averages) has been identified. All households in the community will be sent a letter offering one smoker (18 years or older; 10 or more cigarettes per day) in the household a free-of-charge mailed five-week supply of nicotine patches (up to a total of 800 five-week kits will be available for distribution). Participants receiving nicotine patches will be asked to complete a six-month follow-up survey assessing tobacco cessation defined as 30-day point prevalence abstinence. In addition, attempts will be made to employ ongoing national population surveys containing cigarette smoking variables to compare changes in smoking prevalence in the target community to other communities with similar characteristics. DISCUSSION: We will examine whether the concentrated distribution of mailed nicotine patches will result in a measurable reduction in smoking rates in the target community. If demonstrated, this would provide support for the targeted population-level distribution of an effective individual-level public health intervention. CLINICAL TRIALS REGISTRATION: NCT04534231.

Use of additional nicotine replacement therapy by participants in a five-year follow-up of a tobacco cessation trial.

INTRODUCTION: Using data from an extended follow-up of a randomized trial of mailed nicotine patches, the current secondary analysis explores the continued level of interest in nicotine replacement therapy (NRT) as a means to promote tobacco cessation and whether the purchase of additional NRT was related to tobacco cessation. METHODS: Attempts were made to re-contact participants (N = 999) from a randomized trial of mailed nicotine patches to take part in a five-year follow-up. Those contacted were asked about their current smoking status, interest in free-of-charge NRT, and purchase of other NRT in the time since the 6-month follow-up. RESULTS: A total of 518 participants were successfully interviewed at the five-year time point. While 43.6% of these participants purchased additional NRT, this purchase was unrelated to success at tobacco cessation or to initial group randomization (received/did not received nicotine patches at baseline). Current smokers reported continued interest in receiving free-of charge NRT (77.2% were interested). Participants in the intervention group who reported using all of the nicotine patches they received at baseline (31.8%) were more likely to report purchasing additional NRT (54.9% versus 39.1%; p = .02) and to report not currently smoking at the five-year follow-up (46.2% versus 27.2%; p = .006) compared to those who used some or none of the nicotine patches mailed to them. CONCLUSIONS: The present study found no consistent evidence that NRT is related to long-term success at tobacco cessation. Smokers remain interested in NRT as a means to help them quit smoking.

To thine own self, be true: Examining change in self-reported alcohol measures over time as related to socially desirable responding bias among people with unhealthy alcohol use.

BACKGROUND: Due to a conscious or unconscious desire to be perceived favorably by others, some participants may under or overexaggerate when reporting sensitive behaviors or attitudes, including those related to addictions. This socially desirable responding bias should be considered when using self-reports in predictive models since it introduces error. Methods: A total of 1711 participants were recruited using Amazon's Mechanical Turk crowdsourcing platform for two randomized controlled trials investigating the effectiveness of brief online interventions for hazardous alcohol use. At baseline, participants completed the Balanced Inventory of Desirable Responding (BIDR). Four measures of alcohol use were collected at baseline and follow-up: number of drinks consumed in a typical week, on one occasion, consequences experienced, and amount of perceived risk of injury or illness from alcohol use. Results: As expected, individuals scoring high on the BIDR subscales reported less alcohol use and related behaviors (p < 0.05); however, repeating the analyses for each gender showed no difference for females asked direct questions about the frequency of their alcohol use. Mixed-effects models investigating the interaction of socially desirable responding bias over time on alcohol-related measures showed some significant differences in the amount of change reported depending on BIDR scores. Participants with higher self-deceptive enhancement scores reported less change over time in their ratings of risk of illness or injury (p = 0.001) compared to lower-scoring participants. Likewise, high-scoring participants reported less change in the number of consequences experienced due to alcohol use over time on both BIDR subscales. Neither direct measure of alcohol use seemed affected by BIDR scores over time. A different pattern was found in males and females analyzed separately. Conclusions: These findings suggest that researchers should consider including measures of socially desirable responding bias in longitudinal studies involving self-reported alcohol use, particularly when modeling alcohol-related measures using rating scales across time. In addition, separate gender analyses may be appropriate. Trial registration: ClinicalTrials.gov NCT03008928. Registered 30 December 2016; ClinicalTrials.gov NCT03060135. Registered 17 February 2017.

Examining Change in Self-Reported Gambling Measures Over Time as Related to Socially Desirable Responding Bias.

Socially desirable responding is a response bias that can affect the accuracy of self-reports. It is especially likely when questions address sensitive topics, such as gambling attitudes, problems and behaviours. A sample of 321 participants were recruited from Amazon's mTurk crowdsourcing platform for a randomized controlled trial investigating an online gambling intervention. Data from this study was used to examine the influence of socially desirable responding on gambling self-report measures over time. At baseline, self-deception (SD), a factor of socially desirable responding, was significantly higher among males than females and among those with household incomes greater than $20,000 per year. Controlling for demographic variability, mixed effects models examining the relationship between socially desirable responding factors [SD and impression management (IM)] and time were conducted. Among males, there were significant interactions between IM with the NORC DSM-IV screen for gambling problems (NODS) and the gambling symptom assessment scale (G-SAS) scores respectively, over time. In other words, males with higher IM scores, demonstrated less change in NODS and G-SAS scores from baseline to 6-month follow-up compared to males with lower IM scores. There were no significant interactions in any models among females or among the full sample. Controlling the well-documented effect of socially desirable responding on self-reported measures in addictions research should be considered as a method to help reduce error and improve validity. Future research should continue to examine the effect of this bias on gambling measures over time and in each gender.Trial registration: https://ClinicalTrials.gov/NCT03124589 , registered 19 January 2017.

Targeting mailed nicotine patch distribution interventions to rural regions of Canada: protocol for a randomized controlled trial.

BACKGROUND: Quitting smoking is the most effective way of reducing the risk of cancer among smokers. One way of helping people stop smoking is to provide them with free Nicotine Replacement Therapy (NRT), such as when NRT is sent to people by postal mail as part of a mass distribution initiative. Our previous research indicated that there may be a substantial impact on increasing quit rates of a mailed NRT intervention in rural areas. The current research seeks to confirm this finding and to understand the social determinants of health driving these anticipated large effects. METHODS/DESIGN: Telephone numbers will be randomly selected from across rural regions of Canada in order to recruit adult smokers interested in completing a smoking survey and willing to be interviewed again in 6 months. The survey will ask participants about their smoking history, demographic characteristics, and a hypothetical question: would they be interested in receiving nicotine patches if they were provided to them free of charge? Half of the smokers interested in receiving nicotine patches will be selected by chance and offered the NRT package. The other half of smokers will not be offered the nicotine patches. In addition, the municipality where each participant lives will be identified and, once the relevant general population data becomes available, attempts will be made to link participant data to relevant municipal characteristics (e.g., smoking rates, availability of health services). Characteristics of the participants and the municipalities in which they live will be used to explain why the nicotine patch intervention may have a larger impact in some rural regions compared to others. DISCUSSION: The findings from the proposed RCT are timely and of high relevance as the distribution of nicotine patches has substantial potential to combat the public health problem of cigarette related cancer, other diseases, and premature death from tobacco use. Targeting such tobacco cessation initiatives to rural regions may substantially increase the impact of this intervention, helping to optimize the use of limited prevention resources while aiming to save the maximum number of lives. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov NCT04606797 , October, 27, 2020.