scholarly journals Nicotine replacement treatment, e-cigarettes and an online behavioural intervention to reduce relapse in recent ex-smokers: a multinational four-arm RCT

2020 ◽  
Vol 24 (68) ◽  
pp. 1-82
Author(s):  
Hayden J McRobbie ◽  
Anna Phillips-Waller ◽  
Catherine El Zerbi ◽  
Ann McNeill ◽  
Peter Hajek ◽  
...  
Keyword(s):  
Usual Care ◽  
Electronic Cigarettes ◽  
Health Technology ◽  
Text Messages ◽  
Nicotine Replacement ◽  
Replacement Treatment ◽  
Stop Smoking ◽  
Oral Nicotine ◽  
Structured Planning ◽  
Relapse Rates

Background Relapse remains an unresolved issue in smoking cessation. Extended stop smoking medication use can help, but uptake is low and several behavioural relapse prevention interventions have been found to be ineffective. However, opportunistic ‘emergency’ use of fast-acting nicotine replacement treatment or electronic cigarettes may be more attractive and effective, and an online behavioural Structured Planning and Prompting Protocol has shown promise. The present trial aimed to evaluate the clinical effectiveness and cost-effectiveness of these two interventions. Design A randomised controlled trial. Setting English stop smoking services and Australian quitlines, Australian social media and St Vincent’s Hospital Melbourne, Fitzroy, VIC. Participants Ex-smokers abstinent for at least 4 weeks, with some participants in Australia also recruited from 1 week post quit date. The planned sample size was 1400, but the trial was curtailed when 235 participants were recruited. Interventions Participants were randomised in permuted blocks of random sizes to (1) oral nicotine replacement treatment/electronic cigarettes to use if at risk of relapse, plus static text messages (n = 60), (2) the Structured Planning and Prompting Protocol and interactive text messages (n = 57), (3) oral nicotine replacement treatment/electronic cigarettes plus the Structured Planning and Prompting Protocol with interactive text messages (n = 58) or (4) usual care plus static text messages (n = 59). Outcome measures Owing to delays in study set-up and recruitment issues, the study was curtailed and the primary outcome was revised. The original objective was to determine whether or not the two interventions, together or separately, reduced relapse rates at 12 months compared with usual care. The revised primary objective was to determine whether or not number of interventions received (i.e. none, one or two) affects relapse rate at 6 months (not biochemically validated because of study curtailment). Relapse was defined as smoking on at least 7 consecutive days, or any smoking in the last month at final follow-up for both the original and curtailed outcomes. Participants with missing outcome data were included as smokers. Secondary outcomes included sustained abstinence (i.e. no more than five cigarettes smoked over the 6 months), nicotine product preferences (e.g. electronic cigarettes or nicotine replacement treatment) and Structured Planning and Prompting Protocol coping strategies used. Two substudies assessed reactions to interventions quantitatively and qualitatively. The trial statistician remained blinded until analysis was complete. Results The 6-month relapse rates were 60.0%, 43.5% and 49.2% in the usual-care arm, one-intervention arm and the two-intervention arm, respectively (p = 0.11). Sustained abstinence rates were 41.7%, 54.8% and 50.9%, respectively (p = 0.17). Electronic cigarettes were chosen more frequently than nicotine replacement treatment in Australia (71.1% vs. 29.0%; p = 0.001), but not in England (54.0% vs. 46.0%; p = 0.57). Of participants allocated to nicotine products, 23.1% were using them daily at 6 months. The online intervention received positive ratings from 63% of participants at 6 months, but the majority of participants (72%) completed one assessment only. Coping strategies taught in the Structured Planning and Prompting Protocol were used with similar frequency in all study arms, suggesting that these are strategies people had already acquired. Only one participant used the interactive texting, and interactive and static messages received virtually identical ratings. Limitations The inability to recruit sufficient participants resulted in a lack of power to detect clinically relevant differences. Self-reported abstinence was not biochemically validated in the curtailed trial, and the ecological momentary assessment substudy was perceived by some as an intervention. Conclusions Recruiting recent ex-smokers into an interventional study proved problematic. Both interventions were well received and safe. Combining the interventions did not surpass the effects of each intervention alone. There was a trend in favour of single interventions reducing relapse, but it did not reach significance and there are reasons to interpret the trend with caution. Future work Further studies of both interventions are warranted, using simpler study designs. Trial registration Current Controlled Trials ISRCTN11111428. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 68. See the NIHR Journals Library website for further project information. Funding was also provided by the National Health and Medical Research Council, Canberra, ACT, Australia (NHMRC APP1095880). Public Health England provided the funds to purchase the nicotine products in England.

scholarly journals Combining mirtazapine with SSRIs or SNRIs for treatment-resistant depression: the MIR RCT

2018 ◽  
Vol 22 (63) ◽  
pp. 1-136 ◽  
Author(s):  
David Kessler ◽  
Alison Burns ◽  
Debbie Tallon ◽  
Glyn Lewis ◽  
Stephanie MacNeill ◽  
...  
Keyword(s):  
Primary Care ◽  
Health Technology Assessment ◽  
Usual Care ◽  
Reuptake Inhibitor ◽  
Technology Assessment ◽  
Primary Outcome ◽  
Health Technology ◽  
Treatment Resistant Depression ◽  
Treatment Resistant ◽  
Resistant Depression

Background Depression is usually managed in primary care and antidepressants are often the first-line treatment, but only half of those treated respond to a single antidepressant. Objectives To investigate whether or not combining mirtazapine with serotonin–noradrenaline reuptake inhibitor (SNRI) or selective serotonin reuptake inhibitor (SSRI) antidepressants results in better patient outcomes and more efficient NHS care than SNRI or SSRI therapy alone in treatment-resistant depression (TRD). Design The MIR trial was a two-parallel-group, multicentre, pragmatic, placebo-controlled randomised trial with allocation at the level of the individual. Setting Participants were recruited from primary care in Bristol, Exeter, Hull/York and Manchester/Keele. Participants Eligible participants were aged ≥ 18 years; were taking a SSRI or a SNRI antidepressant for at least 6 weeks at an adequate dose; scored ≥ 14 points on the Beck Depression Inventory-II (BDI-II); were adherent to medication; and met the International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, criteria for depression. Interventions Participants were randomised using a computer-generated code to either oral mirtazapine or a matched placebo, starting at a dose of 15 mg daily for 2 weeks and increasing to 30 mg daily for up to 12 months, in addition to their usual antidepressant. Participants, their general practitioners (GPs) and the research team were blind to the allocation. Main outcome measures The primary outcome was depression symptoms at 12 weeks post randomisation compared with baseline, measured as a continuous variable using the BDI-II. Secondary outcomes (at 12, 24 and 52 weeks) included response, remission of depression, change in anxiety symptoms, adverse events (AEs), quality of life, adherence to medication, health and social care use and cost-effectiveness. Outcomes were analysed on an intention-to-treat basis. A qualitative study explored patients’ views and experiences of managing depression and GPs’ views on prescribing a second antidepressant. Results There were 480 patients randomised to the trial (mirtazapine and usual care, n = 241; placebo and usual care, n = 239), of whom 431 patients (89.8%) were followed up at 12 weeks. BDI-II scores at 12 weeks were lower in the mirtazapine group than the placebo group after adjustment for baseline BDI-II score and minimisation and stratification variables [difference –1.83 points, 95% confidence interval (CI) –3.92 to 0.27 points; p = 0.087]. This was smaller than the minimum clinically important difference and the CI included the null. The difference became smaller at subsequent time points (24 weeks: –0.85 points, 95% CI –3.12 to 1.43 points; 12 months: 0.17 points, 95% CI –2.13 to 2.46 points). More participants in the mirtazapine group withdrew from the trial medication, citing mild AEs (46 vs. 9 participants). Conclusions This study did not find convincing evidence of a clinically important benefit for mirtazapine in addition to a SSRI or a SNRI antidepressant over placebo in primary care patients with TRD. There was no evidence that the addition of mirtazapine was a cost-effective use of NHS resources. GPs and patients were concerned about adding an additional antidepressant. Limitations Voluntary unblinding for participants after the primary outcome at 12 weeks made interpretation of longer-term outcomes more difficult. Future work Treatment-resistant depression remains an area of important, unmet need, with limited evidence of effective treatments. Promising interventions include augmentation with atypical antipsychotics and treatment using transcranial magnetic stimulation. Trial registration Current Controlled Trials ISRCTN06653773; EudraCT number 2012-000090-23. Funding This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 63. See the NIHR Journals Library website for further project information.

scholarly journals Outcomes and Cost-Effectiveness of Two Nicotine Replacement Treatment Delivery Models for a Tobacco Quitline

2011 ◽  
Vol 8 (5) ◽  
pp. 1547-1559 ◽  
Author(s):  
Jessie E. Saul ◽  
Rebecca Lien ◽  
Barbara Schillo ◽  
Annette Kavanaugh ◽  
Ann Wendling ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Nicotine Replacement ◽  
Treatment Delivery ◽  
Replacement Treatment ◽  
Delivery Models

scholarly journals A Comparison of Dependence across Different Types of Nicotine Containing Products and Coffee

2018 ◽  
Vol 15 (8) ◽  
pp. 1609
Author(s):  
Karl Fagerstrom
Keyword(s):  
Data Collection ◽  
Random Sample ◽  
Electronic Cigarettes ◽  
Coffee Consumption ◽  
Cigarette Use ◽  
Tobacco Products ◽  
Nicotine Replacement ◽  
Heavy Smoking ◽  
Different Types ◽  
Smoking Index

Introduction: Few studies have compared the dependence to different tobacco and nicotine products. Even less is known about how it relates to dependence on other common drugs, e.g., caffeine. In this study degree of dependence was compared between snus, cigarettes, nicotine replacement (NR), electronic cigarettes and coffee. Methods: A random sample of Swedish citizens belonging to an internet panel were contacted from September to October 2017. The responders were asked among other related things about their use of snus, NR, traditional cigarette or e-cigarette use and coffee consumption. The indicators of dependence used were: (A) the Heavy Smoking Index, (B) The proportions that used within 30 min after raising in the morning, (C) rating the first use in the morning as the most important and (D) Stating that it would be very hard to give up entirely. Results: Significantly fewer coffee drinkers started use within 30 min of awakening compared with all other products. The first use of the day was found to be more important for snus users compared with other products. On HSI there was no difference between snus and cigarettes. Snus and cigarettes were rated as being more difficult to give up than NR and coffee. Conclusion: Dependence to traditional cigarettes and snus seem to be relatively similar while NR was rated lower and coffee lowest. Since the prevalence of caffeine use in all forms is so much more prevalent than nicotine there might be more persons in the society heavily dependent on caffeine. Implication: Tobacco products are likely more dependence forming than NR products and coffee although there might be more people dependent on caffeine. The addiction to coffee or caffeine is seldom discussed in the society probably because of the little or no harm it causes. Funding: The Snus Commission in Sweden (snuskommissionen) funded the data collection. No funding used for the analysis and writing of manuscript.

scholarly journals Knowledge and Education as Barriers and Facilitators to Nicotine Replacement Therapy Use for Smoking Cessation in Pregnancy: A Qualitative Study with Health Care Professionals

2019 ◽  
Vol 16 (10) ◽  
pp. 1814 ◽  
Author(s):  
Ross Thomson ◽  
Lisa McDaid ◽  
Joanne Emery ◽  
Felix Naughton ◽  
Sue Cooper ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Replacement Therapy ◽  
Nicotine Replacement Therapy ◽  
Health Care Professionals ◽  
Educational Interventions ◽  
Barriers And Facilitators ◽  
Nicotine Replacement ◽  
Smoking During Pregnancy ◽  
Stop Smoking ◽  
In Pregnancy

Smoking during pregnancy is a leading cause of negative pregnancy and perinatal outcomes. While UK guidelines recommend nicotine replacement therapy (NRT) for smoking cessation during pregnancy, adherence to NRT is generally low and may partially explain why NRT appears less effective in pregnancy compared to non-pregnant smokers. This study aimed to identify and describe factors associated with NRT adherence from a health professional’s perspective. Two focus groups and one expert group were conducted with 26 professionals involved in antenatal stop smoking services and the data were analysed thematically using a template methodology. From our analyses, we extracted two main themes: (i) ‘Barriers to NRT use in pregnancy’ explores the issues of how misinformation and unrealistic expectations could discourage NRT use, while (ii) ‘Facilitators to NRT use in pregnancy’ describes the different information, and modes of delivery, that stop smoking professionals believe will encourage correct and sustained NRT use. Understanding the barriers and facilitators to improve NRT adherence may aid the development of educational interventions to encourage NRT use and improve outcomes for pregnant women wanting to stop smoking.

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