NCT05552534

Brief Summary

Smoking cessation assistance is one of the major issues in prevention policies because the prevalence of smoking remains high in France. With its numerous consultations, an emergency service seems to be an interesting place for setting up and helping with weaning, despite specific working conditions. The study, which is a pilot, is interested in the feasibility and efficacy of the implementation of a STIR (Screening, Treatment Intervention and Referral) protocol, which screening, brief intervention, nicotine replacement therapy and referral to a specialist in order to help the patients in smoking cessation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2022

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 23, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

November 3, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2024

Completed
Last Updated

March 24, 2025

Status Verified

March 1, 2025

Enrollment Period

1.5 years

First QC Date

April 4, 2022

Last Update Submit

March 20, 2025

Conditions

Tobacco Cessation

Keywords

Emergency medicinePublic HealthAddictionologySmoking cessationTobacco dependence treatment

Outcome Measures

Primary Outcomes (1)

  • Feasibility and efficacy of a smoking cessation intervention

    Composite outcome: Proportion of patients who participated in follow-up consultations at 3 months after going to the emergency room and proportion of patients weaned from smoking at three months in the intervention group, compared to the control group. A patient is said to be weaned if he / she declares having stopped smoking for 7 days 3 months after his / her visit to the emergency room

    3 months after emergency consultation

Secondary Outcomes (11)

  • proportion of patients who participated in consultations at D7 and M1

    Day 7 and 1 month after emergency consultation

  • description of the procedure (duration of the inclusion)

    4 months

  • number of patients who refused to participate

    4 months

  • Number of doctors/paramedics involved, and of staff who performed the follow-up

    4 months

  • Feasibility of measuring exhaled carbon monoxide

    3 months after emergency consultation

  • +6 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL
Other: STIR PROTOCOL

Control group

NO INTERVENTION

Interventions

STIR PROTOCOLOTHER

Screening, STIR protocol (screening, brief intervention, incentive to download the tobacco info service application, delivery of the "tobacco-info-service" brochure, initiation of a nicotine patch made by the trained emergency nurse or doctor) then three consultations face-to-face or remotely with a member of the team addictionology at 7 days, 1 and 3 months.

Intervention group

Eligibility Criteria

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

You may qualify if:

  • Age \>= to 18 years old
  • Active smoker defined by having smoked at least 100 cigarettes in total in his life, associated with daily consumption or weekly
  • Free and informed consent signed by the patient
  • Patient with an understanding of the French language to participate in the intervention if necessary
  • Patient affiliated to a social security regimen
  • Age ≥ 18 years
  • Caregiver working in one of the 3 departments participating in the study
  • Signature of free and informed consent

You may not qualify if:

  • Absolute vital emergency
  • Pregnant or breastfeeding women
  • Contraindication to taking nicotine
  • Taking nicotine by patch or gum or e-cigarette
  • Patient under AME (national medical insurance)
  • Patients under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emergency department Hospital Pitié-Salpêtrière

Paris, 75013, France

Location

MeSH Terms

Conditions

Tobacco Use CessationSmoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Anne Laure Philippon, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 4, 2022

First Posted

September 23, 2022

Study Start

November 3, 2022

Primary Completion

May 3, 2024

Study Completion

August 3, 2024

Last Updated

March 24, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)