Background:
Recently, new products have appeared on the market containing tobacco and/or nicotine (e.g. heated tobacco cigarettes, electronic cigarettes or other new and emerging products). In Italy, these new products mainly lead to dual use or poly-use.

Objectives:
The Italian Clinical Practice Guideline (CPG) for the treatment of tobacco and nicotine dependence includes both the treatment of conventional tobacco dependence and the treatment of nicotine dependence, induced by the new and emerging products containing tobacco and/or nicotine. The National Centre on Addiction and Doping of the Istituto Superiore di Sanità defined the objectives and scope of this updated CPG.

Materials and methods:
A multidisciplinary panel of clinical experts, together with experts in systematic literature review, identified and prioritized 9 clinical questions related to the treatment of tobacco and nicotine dependence. The applied process was consistent with the Methodological Manual for the production of CPGs (by the National Centre for Clinical excellence, National Guidelines System). The Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology was used to assess the certainty of evidence and make recommendations. The reporting of the guideline was prepared in accordance with the AGREE Reporting Checklist (Appraisal of Guidelines for Research and Evaluation).

Results:
The guideline included 9 clinical questions, 4 of which related to behavioral interventions (including brief advice, counselling and digital interventions), 4 related to pharmacological interventions (including pharmacological interventions alone or in association with behavioral support), and one related to the training of healthcare professionals. The results of the systematic reviews conducted for each question were discussed with the multidisciplinary panel and, by using the GRADE Evidence to Decision (EtD) framework, 29 recommendations for clinical practice, 1 recommendation for further studies and 8 Good Practice Statements, were issued.

Conclusions:
To our knowledge, this is the first CPG that includes the treatment of nicotine dependence as well as the treatment of conventional tobacco dependence following a standardized and internationally recognized methodology.