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      A Single-Arm, Open-Label, Pilot, and Feasibility Study of a High Nicotine Strength E-Cigarette Intervention for Smoking Cessation or Reduction for People With Schizophrenia Spectrum Disorders Who Smoke Cigarettes

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      , PhD 1 , 2 , , PhD 3 , , MD 4 , , Lyc Psych 5 , , MD, PhD 6 , 7
      Nicotine & Tobacco Research
      Oxford University Press

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          Abstract

          Introduction

          An estimated 60%–90% of people with schizophrenia smoke, compared with 15%–24% of the general population, exacerbating the already high morbidity and mortality rates observed in this population.

          Aims and Methods

          This study aimed to assess the feasibility of using a new-generation high strength nicotine e-cigarette to modify smoking behavior in individuals with schizophrenia spectrum disorders who smoke cigarettes. A single-arm pilot study was conducted with 40 adults with schizophrenia spectrum disorders who smoked and did not intend to reduce or quit smoking. Participants were given a 12-week supply of a JUUL e-cigarette loaded with a 5% nicotine pod. The primary outcome was smoking cessation at week 12. Additional outcomes included: smoking reduction, continuous abstinence at week 24, adoption rate, adherence to the e-cigarette, feasibility, acceptability, and subjective effects.

          Results

          Sixteen (40%) participants quit by the end of 12 weeks. For the whole sample, we observed an overall, sustained 50% reduction in smoking or smoking abstinence in 37/40 (92.5%) of participants and an overall 75% reduction in median cigarettes per day from 25 to six was observed by the end of the 12 weeks ( p < .001).

          Conclusions

          A high strength nicotine e-cigarette has the potential to help people with schizophrenia spectrum disorders to quit or reduce smoking. Further research with a larger sample and a comparator group is needed. The results provide useful information and direction to augment the existing body of knowledge on smoking cessation for people with schizophrenia spectrum disorders.

          Implications

          Considering that most people with schizophrenia spectrum disorders continue smoking, alternative and efficient interventions to reduce or prevent morbidity and mortality are urgently needed. This study showed that adults who smoke and were not motivated to quit, when provided a new-generation e-cigarette with high nicotine content, demonstrated substantially decreased cigarette consumption without causing significant side effects. Although not specifically measured in this study, nicotine absorption in new-generation devices has been shown to be consistently superior compared with the first generation of e-cigarette devices, and this may help explain the lower quit rates in studies using earlier generation devices.

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          Most cited references63

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          Diagnostic and Statistical Manual of Mental Disorders

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            The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions.

            CONSORT guidelines call for precise reporting of behavior change interventions: we need rigorous methods of characterizing active content of interventions with precision and specificity. The objective of this study is to develop an extensive, consensually agreed hierarchically structured taxonomy of techniques [behavior change techniques (BCTs)] used in behavior change interventions. In a Delphi-type exercise, 14 experts rated labels and definitions of 124 BCTs from six published classification systems. Another 18 experts grouped BCTs according to similarity of active ingredients in an open-sort task. Inter-rater agreement amongst six researchers coding 85 intervention descriptions by BCTs was assessed. This resulted in 93 BCTs clustered into 16 groups. Of the 26 BCTs occurring at least five times, 23 had adjusted kappas of 0.60 or above. "BCT taxonomy v1," an extensive taxonomy of 93 consensually agreed, distinct BCTs, offers a step change as a method for specifying interventions, but we anticipate further development and evaluation based on international, interdisciplinary consensus.
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              How we design feasibility studies.

              Public health is moving toward the goal of implementing evidence-based interventions. To accomplish this, there is a need to select, adapt, and evaluate intervention studies. Such selection relies, in part, on making judgments about the feasibility of possible interventions and determining whether comprehensive and multilevel evaluations are justified. There exist few published standards and guides to aid these judgments. This article describes the diverse types of feasibility studies conducted in the field of cancer prevention, using a group of recently funded grants from the National Cancer Institute. The grants were submitted in response to a request for applications proposing research to identify feasible interventions for increasing the utilization of the Cancer Information Service among underserved populations.
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                Author and article information

                Journal
                Nicotine Tob Res
                Nicotine Tob Res
                nictob
                Nicotine & Tobacco Research
                Oxford University Press (US )
                1462-2203
                1469-994X
                July 2021
                16 March 2021
                16 March 2021
                : 23
                : 7
                : 1113-1122
                Affiliations
                [1 ] Department of Educational Science, University of Catania , Catania, Italy
                [2 ] Faculty of Health Science and Sport, University of Stirling , Stirling, UK
                [3 ] Hunter Bellevue School of Nursing, Hunter College-City University of New York , New York, NY, USA
                [4 ] Clinical and Translational Science Center, Weill Cornell Medicine , New York, NY, USA
                [5 ] Centro per la Prevenzione e Cura del Tabagismo (CPCT), Azienda Ospedaliero-Universitaria “G.Rodolico-S. Marco”, Università di Catania , Catania, Italy
                [6 ] Center of Excellence for the Acceleration of Harm Reduction (CoEHAR), University of Catania , Catania, Italy
                [7 ] Department of Clinical and Experimental Medicine, University of Catania , Catania, Italy
                Author notes
                Corresponding Author: Pasquale Caponnetto, PhD, University of Catania, via Santa Sofia 78, Catania, Italy. Telephone: 39-095-378-1537; Fax: 39-095-378-1567; E-mail: p.caponnetto@ 123456unict.it
                Article
                ntab005
                10.1093/ntr/ntab005
                8186418
                33723598
                c1d87a7e-7759-4a35-9570-a50558e11a05
                © The Author(s) 2021. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 17 June 2020
                : 05 January 2021
                : 18 January 2021
                : 16 March 2021
                Page count
                Pages: 10
                Categories
                Original Investigations
                AcademicSubjects/MED00010
                AcademicSubjects/SOC02541

                Agriculture
                Agriculture

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