Trial Comparing Different Methods of Support With Stopping Smoking (PORTSSS/Stop Together Trial)
NCT ID: NCT00775944
Last Updated: 2012-10-26
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
2591 participants
INTERVENTIONAL
2009-02-28
2010-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This trial will determine whether or not: (1)additional (proactive) telephone support for smoking cessation delivered to users of the National Health Service (NHS)Smoking Helpline, is more effective than standard support given by the helpline, and (2) whether the offer of free Nicotine Replacement Therapy influences rates of stopping smoking in individuals receiving either standard (reactive) or proactive telephone support.
Current smokers over 16 years of age will be recruited by helpline staff with the appropriate consent. Participants will then be randomised into one of four groups:
(i) usual care delivered by the helpline (called the Together Programme) (ii) usual care plus a programme of proactive telephone counselling (iii) usual care AND the offer of Nicotine Replacement Therapy (NRT) (iv) usual helpline support, proactive telephone counselling AND the offer of NRT.
The researchers will not be aware of which group participants have been allocated. The results will determine if the use of proactive telephone counselling is effective in helping individuals to stop smoking. It shall also find out if the offer of NRT medication via a telephone helpline assists individuals in their efforts to stop smoking.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Standard support
Standard 'Together Programme' telephone support for smoking cessation \& advice to obtain nicotine addiction treatment
Reactive (standard) telephone support
Reactive counselling usually involves the provision of evidence-based information to support quit attempts without any or with only very brief counselling to accompany it.
Proactive telephone support
Proactive support \& advice to obtain nicotine addiction treatment
Proactive telephone support
Pro-active telephone counselling allows for repeated, sequenced calls to be made by quitline counsellors to smokers and for counselling to be provided during accepted calls.
Standard support & offer NRT
Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
Reactive (standard) telephone support
Reactive counselling usually involves the provision of evidence-based information to support quit attempts without any or with only very brief counselling to accompany it.
Offer of voucher for cost-free Nicotine Replacement Therapy
Offer of voucher for cost-free Nicotine Replacement Therapy over the telephone
Proactive support & offer NRT
Proactive telephone support and offer of voucher for cost free NRT
Proactive telephone support
Pro-active telephone counselling allows for repeated, sequenced calls to be made by quitline counsellors to smokers and for counselling to be provided during accepted calls.
Offer of voucher for cost-free Nicotine Replacement Therapy
Offer of voucher for cost-free Nicotine Replacement Therapy over the telephone
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Proactive telephone support
Pro-active telephone counselling allows for repeated, sequenced calls to be made by quitline counsellors to smokers and for counselling to be provided during accepted calls.
Reactive (standard) telephone support
Reactive counselling usually involves the provision of evidence-based information to support quit attempts without any or with only very brief counselling to accompany it.
Offer of voucher for cost-free Nicotine Replacement Therapy
Offer of voucher for cost-free Nicotine Replacement Therapy over the telephone
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
16 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Department of Health, United Kingdom
OTHER_GOV
University of Nottingham
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tim Coleman, MB ChB
Role: PRINCIPAL_INVESTIGATOR
University of Nottingham
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Nottingham
Nottingham, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Silagy C, Mant D, Fowler G, Lancaster T. Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2000;(3):CD000146. doi: 10.1002/14651858.CD000146.
Tobacco Advisory Group of the Royal College of Physicians. Going smoke-free: The case for clean air in the home, at work and in public places. London: Royal College of Physicians of London, 2005.
Tobacco Advisory Group of the Royal College of Physicians. Nicotine addiction in Britain. London: Royal College of Physicians of London, 2000.
Ashenden R, Silagy C, Weller D. A systematic review of the effectiveness of promoting lifestyle change in general practice. Fam Pract. 1997 Apr;14(2):160-76. doi: 10.1093/fampra/14.2.160.
Pierce JP, White MM, Gilpin EA. Adolescent smoking decline during California's tobacco control programme. Tob Control. 2005 Jun;14(3):207-12. doi: 10.1136/tc.2004.010116.
Hughes JR, Stead LF, Lancaster T. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2000;(4):CD000031. doi: 10.1002/14651858.CD000031.
Tonstad S, Tonnesen P, Hajek P, Williams KE, Billing CB, Reeves KR; Varenicline Phase 3 Study Group. Effect of maintenance therapy with varenicline on smoking cessation: a randomized controlled trial. JAMA. 2006 Jul 5;296(1):64-71. doi: 10.1001/jama.296.1.64.
Ferguson J, Bauld L, Chesterman J, Judge K. The English smoking treatment services: one-year outcomes. Addiction. 2005 Apr;100 Suppl 2:59-69. doi: 10.1111/j.1360-0443.2005.01028.x.
Stead LF, Lancaster T. Group behaviour therapy programmes for smoking cessation. Cochrane Database Syst Rev. 2000;(2):CD001007. doi: 10.1002/14651858.CD001007.
Lancaster T, Stead LF. Individual behavioural counselling for smoking cessation (Cochrane Review). The Cochrane Library, Issue 4, Chichester, UK: John Wiley & Sons, Ltd, 2003.
Coleman T, Lewis S, Hubbard R, Smith C. Impact of contractual financial incentives on the ascertainment and management of smoking in primary care. Addiction. 2007 May;102(5):803-8. doi: 10.1111/j.1360-0443.2007.01766.x.
Britton J, Lewis S. Trends in the uptake and delivery of smoking cessation services to smokers in Great Britain. J Epidemiol Community Health. 2004 Jul;58(7):569-70. doi: 10.1136/jech.2003.015271. No abstract available.
Stead LF, Lancaster T, Perera R. Telephone counselling for smoking cessation. Cochrane Database Syst Rev. 2003;(1):CD002850. doi: 10.1002/14651858.CD002850.
Platt S, Tannahill A, Watson J, Fraser E. Effectiveness of antismoking telephone helpline: follow up survey. BMJ. 1997 May 10;314(7091):1371-5. doi: 10.1136/bmj.314.7091.1371.
An LC, Schillo BA, Kavanaugh AM, Lachter RB, Luxenberg MG, Wendling AH, Joseph AM. Increased reach and effectiveness of a statewide tobacco quitline after the addition of access to free nicotine replacement therapy. Tob Control. 2006 Aug;15(4):286-93. doi: 10.1136/tc.2005.014555.
Silagy C, Lancaster T, Stead L, Mant D, Fowler G. Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2002;(4):CD000146. doi: 10.1002/14651858.CD000146.
Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.
Ferguson J, Docherty G, Bauld L, Lewis S, Lorgelly P, Boyd KA, McEwen A, Coleman T. Effect of offering different levels of support and free nicotine replacement therapy via an English national telephone quitline: randomised controlled trial. BMJ. 2012 Mar 23;344:e1696. doi: 10.1136/bmj.e1696.
Coleman T, McEwen A, Bauld L, Ferguson J, Lorgelly P, Lewis S. Protocol for the Proactive Or Reactive Telephone Smoking CeSsation Support (PORTSSS) trial. Trials. 2009 Apr 28;10:26. doi: 10.1186/1745-6215-10-26.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
08118
Identifier Type: -
Identifier Source: org_study_id