Dataset Information

Evaluating Treatment Mechanisms of Varenicline: Mediation by Affect and Craving.

ABSTRACT:

Introduction

Negative reinforcement models posit that relapse to cigarette smoking is driven in part by changes in affect and craving during the quit attempt. Varenicline may aid cessation by attenuating these changes; however, this mediational pathway has not been formally evaluated in placebo-controlled trials. Thus, trajectories of negative affect (NA), positive affect (PA), and craving were tested as mediators of the effect of varenicline on smoking cessation.

Aims and methods

Secondary data analysis was conducted on 828 adults assigned to either varenicline or placebo in a randomized controlled trial for smoking cessation (NCT01314001). Self-reported NA, PA, and craving were assessed 1-week pre-quit, on the target quit day (TQD), and 1 and 4 weeks post-TQD.

Results

Across time, NA peaked 1-week post-quit, PA did not change, and craving declined. Less steep rises in NA (indirect effect 95% CI: .01 to .30) and lower mean craving at 1-week post-quit (CI: .06 to .50) were mediators of the relationship between varenicline and higher cessation rates at the end of treatment. PA was associated with cessation but was not a significant mediator.

Conclusions

These results partially support the hypothesis that varenicline improves smoking cessation rates by attenuating changes in specific psychological processes and supported NA and craving as plausible treatment mechanisms of varenicline.

Implications

The present research provides the first evidence from a placebo-controlled randomized clinical trial that varenicline's efficacy is due, in part, to post-quit attenuation of NA and craving. Reducing NA across the quit attempt and craving early into the attempt may be important treatment mechanisms for effective interventions. Furthermore, post-quit NA, PA, and craving were all associated with relapse and represent treatment targets for future intervention development.

SUBMITTER: Tonkin SS

PROVIDER: S-EPMC9596996 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature

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Publications

Evaluating Treatment Mechanisms of Varenicline: Mediation by Affect and Craving.

Tonkin Sarah S SS Colder Craig C Mahoney Martin C MC Swan Gary E GE Cinciripini Paul P Schnoll Robert R George Tony P TP Tyndale Rachel F RF Hawk Larry W LW

Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco 20221001 11

<h4>Introduction</h4>Negative reinforcement models posit that relapse to cigarette smoking is driven in part by changes in affect and craving during the quit attempt. Varenicline may aid cessation by attenuating these changes; however, this mediational pathway has not been formally evaluated in placebo-controlled trials. Thus, trajectories of negative affect (NA), positive affect (PA), and craving were tested as mediators of the effect of varenicline on smoking cessation.<h4>Aims and methods</h4 ...[more]

PMID: 35639828

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Project description:AimsTo identify when smoking cessation treatments affect craving, negative affect and anhedonia, and how these symptoms relate to abstinence, to help evaluate the effects of particular intervention components in multi-component treatments and accelerate treatment refinement.DesignSecondary analysis of data from a two-arm randomized controlled trial.SettingSeven primary care clinics in Wisconsin, United States.ParticipantsAdult primary care patients who smoked daily (n = 574).Intervention and comparatorIntervention was abstinence-optimized treatment (A-OT, n = 276) comprising 3 weeks of nicotine mini-lozenges pre-target quit day (TQD), 26 weeks of combination nicotine patch and mini-lozenges post-TQD and extensive psychosocial support. The comparator was recommended usual care (RUC, n = 298), comprising brief counseling and 8 weeks of nicotine patch post-TQD.MeasurementsTime-varying effect models examined dynamic effects of A-OT (versus RUC) on the primary outcomes of nightly cigarette craving, negative affect and anhedonia from 1 week pre- to 2 weeks post-TQD. Exploratory models examined within-person relations between nicotine medication use and same-day symptom ratings. Secondary logistic regression analyses examined associations between post-TQD craving, negative affect and anhedonia and 1-month post-TQD abstinence.FindingsA-OT significantly suppressed pre- and post-TQD craving (β = -0.27 to -0.46 across days) and post-TQD anhedonia (β = -0.24 to -0.38 across days), relative to RUC. Within individuals, using patches was associated with lower negative affect in RUC (β = -0.42 to -0.52), but not in A-OT. Using more mini-lozenges was associated with greater craving (β = 0.04-0.07) and negative affect (β = 0.03-0.05) early, and with lower anhedonia (β = -0.06 to -0.12) later. Greater post-TQD craving (OR = 0.68) and anhedonia (OR = 0.85) predicted lower odds of abstinence 1 month post-TQD.ConclusionTime-varying effect models showed that a multi-component treatment intervention for smoking cessation suppressed significant withdrawal symptoms more effectively than recommended usual care among daily adult smokers motivated to quit. The intervention reduced craving pre- and post-target quit day (TQD) and anhedonia post-TQD.

Project description:IntroductionResearch shows that abstinence from tobacco leads to a withdrawal-related decrement in responsivity to nondrug rewards (ie, anhedonia). However, it remains unclear how anhedonia relates to other key withdrawal symptoms and withdrawal-related constructs over time. We analyzed ecological momentary assessment data to examine whether a decrement in response to rewards during a 10-day period following quitting shows a pattern of associations with other variables (ie, treatment, tobacco dependence, negative affect, and craving) that is consistent with anhedonia being a tobacco withdrawal symptom.MethodsAs part of a randomized controlled trial of smoking cessation therapies, 1122 adults (58% female) were assigned to: placebo (n = 131), bupropion (alone or with nicotine lozenge; n = 401), or nicotine replacement therapy (NRT; lozenge, patch, both; n = 590). Participants completed 4 ecological momentary assessments per day for 10 days postquit, resulting in 22 575 assessments.ResultsTime-varying effect modeling showed that anhedonia was significantly greater among those high in dependence relative to lower dependent smokers out to day 9 postquit. The placebo group showed elevated anhedonia immediately postquit, which fell to levels similar to the treatment groups by day 7. NRT effectively reduced anhedonia and its time-varying association with craving early in the quit attempt. The positive association between negative affect and anhedonia was moderate and stable over time for both active treatment groups.ConclusionsThese results provide additional support that anhedonia following quitting smoking is a manifestation of the tobacco withdrawal syndrome.ImplicationsThis study supported the hypothesis that diminished responsivity to nondrug rewards (ie, anhedonia) is a symptom of the tobacco withdrawal syndrome. Results showed that anhedonia: (1) was significantly associated with dependence, especially during the early postquit period when withdrawal was at its peak intensity; (2) showed significant time-varying associations with other withdrawal symptoms, especially craving; and (3) was significantly suppressed by agonist administration as was its association with craving over time.

Dataset Information

Evaluating Treatment Mechanisms of Varenicline: Mediation by Affect and Craving.

Introduction

Aims and methods

Results

Conclusions

Implications

Publications

Evaluating Treatment Mechanisms of Varenicline: Mediation by Affect and Craving.

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