Efficacy and Mechanisms of Web-Based Regulation of Craving Training for Smoking Cessation - Abstract/Project Summary Cigarette smoking is the leading preventable cause of disease, disability, and death1. Unfortunately, current smoking cessation treatments are suboptimal, and innovative interventions are needed, particularly those that are accessible and scalable (e.g., brief, digital) and target core mechanisms. Craving2-5 and the ability to regulate craving6-8 are two core mechanisms implicated in smoking. Although pharmacotherapies (e.g., nicotine replacement therapy; NRT) reduce craving and smoking9, 10, they have modest effects on quit rates11, 12 – suggesting pharmacotherapy alone is inadequate. Critically, combining behavioral and pharmacotherapy approaches for smoking cessation is more effective than either alone9. Combining anti-craving pharmacotherapy with a targeted, mechanism-focused behavioral intervention for enhancing regulation of craving may be highly promising, yet is understudied. We developed Regulation of Craving Training (ROC-T)13-17, a brief, digital intervention providing targeted, intensive training in skills to regulate craving, via repeated practice of a skill while viewing smoking-related images that elicit craving. There are two versions of ROC-T: (1) Reappraisal ROC-T (RROC-T)13, 14: training in reappraisal – reframing smoking as an undesired behavior/non-smoking as desired (based on cognitive treatments18, 19); and (2) Mindfulness ROC-T (MROC-T)17, 20: training in mindful- acceptance – accepting craving as it is and letting it pass (based on mindfulness treatments21, 22). Our NIDA- funded Stage 1B trial (n=92) showed that both versions vs. an assessment-only control led to large-sized reductions in craving and smoking23. Given its brief, digital format, and promising results thus far, ROC-T would be ideal as a preparation intervention24-28 added to the beginning of standard care (SC) – NRT and counseling – and prior to quitting. Indeed, individuals with lower craving immediately prior to29-37 and after31, 35, 38-43 the quit date are more likely to stay abstinent from smoking in the long run. We propose a Stage 2 efficacy trial44, 45 with 882 adult cigarette smokers who will receive SC and will be randomized to (1) RROC-T, (2) MROC-T, or (3) Sham ROC-T (control) as adjunctive preparation interventions that are integrated into SC. Each ROC-T includes 6x30-min modules completed during weeks 1-4 in preparation for a quit date at the start of week 5. Sham ROC-T includes neutral images with no skills training. SC includes 7x15-min virtual counseling sessions9, 46 and NRT (patch plus lozenge or gum47, 48; initiated on the quit date). The primary outcome is CO-verified 7-day point prevalence abstinence (PPA) 6-months post-quit. Abstinence will be confirmed with video-based CO testing. To assess real-time craving and skill use in daily life, participants will complete daily ecological momentary assessment (EMA) for 1-week at baseline, and 1- week pre-quit through 4-weeks post-quit. This project has the potential to significantly advance mechanism-targeted, accessible interventions for smoking cessation.
