A randomized controlled trial protocol for engaging distress tolerance and working memory to aid smoking cessation in low socioeconomic status (SES) adults

Abstract

Low income and low educational attainment are among the strongest predictors of both smoking prevalence and lapse (i.e., return) to smoking after cessation attempts. Treatment refinement is limited by inadequate knowledge of the specific lapse- or relapse-relevant vulnerabilities characteristic of populations that should be the target of treatment. In the context of a randomized clinical trial design, we describe an experimental medicine approach for evaluating the role of 2 specific lapse-relevant targets relative to the higher stress characteristic of low-socioeconomic contexts: low distress tolerance and low working memory capacity. Furthermore, we use an innovative approach for understanding risk of smoking lapse in smokers undergoing a quit attempt to examine candidate mechanistic targets assessed not only during nicotine use, but also during the conditions smokers will face upon a cessation attempt-during stressful nicotine-deprivation windows. This study is designed to show the incremental value of assessments during deprivation windows, in part because of the way in which specific vulnerabilities are modified by, and interact with, the heightened stress and withdrawal symptoms inherent to nicotine-deprivation states. Specifically, the study is designed to evaluate whether a novel mindfulness intervention (mindfulness combined with interoceptive exposure) can improve upon existing mindfulness interventions and extend therapeutic gains to the modification of mechanistic targets assessed in high-stress or negative affectivity contexts. The overall goal is to validate mechanistic targets and associated interventions for the purpose of expanding treatment options for at-risk smokers. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Trial registration: ClinicalTrials.gov NCT03565497.

Conflict of interest statement

Conflict of Interest Statement:

Although the following activities/relationships do not create a conflict of interest pertaining to this manuscript, in the interest of full disclosure, the authors would like to report the following. Dr. Bickel would like to report the following: Dr. Otto receives support as a speaker and Chair of the Scientific Advisory Board for Big Health. Dr. Bickel is a principal of HealthSim, LLC; Notifius, LLC; BEAM Diagnostics, Inc.; and Red 5 Group, LLC. In addition, he serves on the scientific advisory board for Sober Grid, Inc.; Ria Health; US WorldMeds, LLC; and is a consultant for Alkermes, Inc. Sandoz, and Nektar Therapeutics. Dr. Smits is a paid clinical advisor to Big Health. No other authors have industry relationships to report.

Figures

Figure 1.

Conceptual model for treatment effects in this study of mindfulness treatment with and without interoceptive exposure on mechanistic variables (negative affectivity/stress, distress tolerance, and working memory capacity), and the effect of these variables on smoking outcomes, with lines indicating potential differential effects for low and high stress contexts (with dashed lines indicating weaker effects of MT relative to MT + IE under high stress/negative affectivity contexts, and the bolded line to the clinical outcomes indicating a stronger relationship between mechanistic outcomes that are evaluated in the high- relative to the low-stress/negative affectivity context).