NCT04854616

Brief Summary

The Cessation of Smoking Trial in the Emergency Department (CoSTED) is an National Institute for Health Research (NIHR) Health Technology Assessment (HTA) funded randomised controlled trial (RCT). The research question is "in people attending the Emergency Department who smoke, does a brief intervention (including the provision of an electronic cigarette (e-cigarette) and referral to stop smoking services) increase smoking cessation in comparison with usual care and is it cost effective?" The trial includes an internal pilot, health economic evaluation and process evaluation. The primary outcome is smoking cessation, self-reported as continuous smoking abstinence, biochemically validated by carbon monoxide monitoring with cut off of ≥8ppm. The sample size is 972 (486 in intervention and control) across 6 sites.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
972

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 22, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

January 4, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

April 30, 2026

Completed
Last Updated

April 30, 2026

Status Verified

December 1, 2023

Enrollment Period

1.2 years

First QC Date

March 26, 2021

Results QC Date

May 1, 2025

Last Update Submit

April 9, 2026

Conditions

Smoking CessationElectronic Cigarette UseE-Cig UseVaping

Keywords

interventionemergency departmente-cigaretteelectronic cigaretteA&EAccident and Emergencyvapingbehavioural interventionstop smoking services

Outcome Measures

Primary Outcomes (1)

  • Continuous Smoking Abstinence

    The primary outcome is smoking cessation, self-reported as continuous smoking abstinence, biochemically validated by carbon monoxide monitoring with cut off of ≥8ppm.This is according to the Russell standard, stated as: continuous abstinence (Russell Standard) \[ Time Frame: Six months post quit date \] Self-report of smoking not more than five cigarettes from the Quit date, supported by biochemical validation (expired air carbon monoxide)

    6 months after randomisation

Secondary Outcomes (11)

  • 7-day Point Prevalence Abstinence

    6 months after randomisation

  • Number of Quit Attempts

    6 months after randomisation

  • Number of Cigarettes Per Day

    6 months after randomisation

  • Nicotine Dependence

    6 months after randomisation

  • Number of Times Using an E-cigarette Per Day

    6 months after randomisation

  • +6 more secondary outcomes

Study Arms (2)

CoSTED Intervention

EXPERIMENTAL

CoSTED is an opportunistic smoking cessation intervention comprising three elements: 1. brief smoking cessation advice 2. the provision of an electronic cigarette (e-cigarette) and training in its use 3. referral to stop-smoking services

Behavioral: CoSTED Intervention

Treatment as Usual

NO INTERVENTION

Signposting to NHS smoking cessation services through provision of written information about local services.

Interventions

CoSTED InterventionBEHAVIORAL

Brief smoking cessation advice, the provision of an e-cigarette starter kit and training in its use, and referral to stop smoking services.

CoSTED Intervention

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults ≥18 years old who are current daily tobacco smokers
  • Current daily tobacco smoker (self-reporting smoking of at least one cigarette per day)
  • Attending the ED for medical treatment (or accompanying a patient attending for medical treatment)
  • Submitting an expired carbon monoxide (CO) breath test reading of more than ≥8 parts per million (ppm).

You may not qualify if:

  • Requiring immediate medical treatment as defined by the treating clinician.
  • In police custody.
  • Known history of allergy to nicotine replacement products.
  • Currently defined as dual users - already using an e-cigarette daily as well as smoking conventional cigarettes.
  • Without the capacity to give informed consent for participation in the study
  • Have taken part in the CoSTED trial already

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norfolk and Norwich University Hospitals NHS Foundation Trust

Norwich, Norfolk, NR4 7UY, United Kingdom

Location

Related Publications (4)

  • Notley C, Clark L, Belderson P, Ward E, Clark AB, Parrott S, Agrawal S, Bloom BM, Boyle AA, Morris G, Gray A, Coats T, Man MS, Bauld L, Holland R, Pope I. Cessation of smoking trial in the emergency department (CoSTED): protocol for a multicentre randomised controlled trial. BMJ Open. 2023 Jan 18;13(1):e064585. doi: 10.1136/bmjopen-2022-064585.

    PMID: 36657751RESULT

  • Ward E, Belderson P, Clark A, Stirling S, Clark L, Pope I, Notley C. How do people quit smoking using e-cigarettes? A mixed-methods exploration of participant smoking pathways following receiving an opportunistic e-cigarette-based smoking cessation intervention. Addiction. 2024 Dec;119(12):2185-2196. doi: 10.1111/add.16633. Epub 2024 Sep 10.

    PMID: 39252616DERIVED

  • Pope I, Clark LV, Clark A, Ward E, Belderson P, Stirling S, Parrott S, Li J, Coats T, Bauld L, Holland R, Gentry S, Agrawal S, Bloom BM, Boyle AA, Gray AJ, Morris MG, Livingstone-Banks J, Notley C. Cessation of Smoking Trial in the Emergency Department (COSTED): a multicentre randomised controlled trial. Emerg Med J. 2024 Apr 22;41(5):276-282. doi: 10.1136/emermed-2023-213824.

    PMID: 38531658DERIVED

  • Belderson P, Ward E, Pope I, Notley C. Selecting an e-cigarette for use in smoking cessation interventions and healthcare services: findings from patient and public consultation for the COSTED trial. BMJ Open. 2024 Mar 4;14(3):e078677. doi: 10.1136/bmjopen-2023-078677.

    PMID: 38443079DERIVED

Related Links

MeSH Terms

Conditions

Smoking CessationVapingEmergencies

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorSmokingDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Ian Pope
Organization
Norfolk and Norwich University Hospitals NHS Foundation Trust
I.Pope@uea.ac.uk
01603 286286

Study Officials

  • Ian Pope, MD

    Norfolk and Norwich University Hospitals NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2021

First Posted

April 22, 2021

Study Start

January 4, 2022

Primary Completion

March 31, 2023

Study Completion

September 30, 2023

Last Updated

April 30, 2026

Results First Posted

April 30, 2026

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Data underlying the main trial results will be available in a public, open access repository immediately following publication of the major findings of the study. Details of the repository and a persistent URL will be provided on publication of the main results. Study protocol, statistical analysis plan, informed consent form, and other documents will also be available.

Locations

GB(1)