NCT04654585

Brief Summary

\- Objective: Our study aims to evaluate the effectiveness of the "STOP" (Sevrage Tabagique à l'aide d'Outils dédiés selon la Préférence: Smoking Cessation using preference-based tools) intervention, a preference-based smoking cessation intervention for smokers with low socio-economic position (SEP). \- Methods : STOP is a randomised, multi-centre, single blinded, intent-to-treat trial. Participating centres include primary care practices (community, municipal or general health clinics), hospital-based facilities, and healthcare institutions specialised in addiction treatment. Smokers with low SEP will be randomised into either the intervention or control group. Persons randomised to the control group will be accompanied by their health professional according to standard practice. Participants randomised to the intervention group will receive the same smoking cessation advice, drug (varenicline, champix,..) prescription and support as participants in the control group, but they will also have a choice of being given free Nicotine Replacement Therapy (NRT) (transdermal patch, gum, spray, inhaler, sublingual tablets/lozenges) and/or an electronic cigarette + e-liquid on the spot to aid their quit attempt. Follow-up appointments will take place at around 7 to 14 days, 1 month, 3 months and 6 months after inclusion, according to the participant and health professional availability. The main outcome measure of this study will be the 7-day point prevalence tobacco abstinence at 6 months after inclusion (yes/no), defined as self-reported abstinence for at least 7 days, This self-reported abstinence will be validated by measured exhaled carbon monoxide, unless this measurement is unavailable due to the ongoing covid-19 pandemic.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
167

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

15 active sites

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

November 27, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 4, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

February 26, 2021

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

December 16, 2024

Status Verified

December 1, 2024

Enrollment Period

3.5 years

First QC Date

November 27, 2020

Last Update Submit

December 10, 2024

Conditions

SmokingSmoking Cessation

Keywords

Electronic Nicotine Delivery SystemsTobacco Use Cessation DevicesPreference-based

Outcome Measures

Primary Outcomes (1)

  • Smoking abstinence at 6 months after inclusion (yes/no)

    Self-reported 7-day point prevalence tobacco abstinence, validated by measured exhaled carbon monoxide, if this measurement is available (depending on the sanitary measures in place due to the ongoing covid-19 pandemic).

    6 months after inclusion

Secondary Outcomes (5)

  • Total number of days of abstinence at 6 months

    6 months after inclusion

  • Smoking abstinence at 1 and 3 months after inclusion (yes/no)

    1 and 3 months after inclusion

  • Number of relapses

    3 and 6 months after inclusion

  • The number of cigarettes smoked per day

    6 months after inclusion

  • Proportion of participants who have significantly reduced daily smoking

    6 months after inclusion

Study Arms (2)

The STOP intervention

EXPERIMENTAL

The stop intervention is a heath professional (medical doctor) led intervention assisting smokers with low socioeconomic position in their smoking cessation attempt. It consists of routine care and adapted advice supplemented with a free delivery of any or several type(s) of nicotine replacement therapy (NRT) (patches, inhalers, gum, tablets, etc.) and/or an e-cigarette + e-liquid. The delivery of those smoking aids is based on the smokers' preference and choice.

Other: The STOP intervention

Standard Care

ACTIVE COMPARATOR

Participants randomised to the standard care group will be given standard care in assisting their smoking cessation attempt, but without free delivery of NRT or e-cigarettes. Standard care includes motivational interviewing, advice to quit and prescription for NRTs. The number and online address of the French smoking cessation support helpline could also be provided. Health professionals will also be in position to prescribe NRT or other treatments (for example: Varenicline or Bupropion) which can help with smoking cessation, according to routine practice. The health professional could also give advice on e-cigarette use if he or she finds it suitable.

Other: Standard Care

Interventions

The STOP interventionOTHER

The stop intervention is a heath professional (medical doctor) led intervention assisting smokers with low socioeconomic position in their smoking cessation attempt. It consists of routine care and adapted advice supplemented with a free delivery of any or several type(s) of nicotine replacement therapy (NRT) (patches, inhalers, gum, tablets, etc.) and/or an e-cigarette + e-liquid. The delivery of those smoking aids is based on the smokers' preference and choice.

The STOP intervention
Standard CareOTHER

Participants randomised to the standard care group will be given standard care in assisting their smoking cessation attempt, but without free delivery of NRT or e-cigarettes. Standard care includes motivational interviewing, advice to quit and prescription for NRTs. The number and online address of the French smoking cessation support helpline could also be provided. Health professionals will also be in position to prescribe NRT or other treatments (for example: Varenicline or Bupropion) which can help with smoking cessation, according to routine practice. The health professional could also give advice on e-cigarette use if he or she finds it suitable.

Standard Care

Eligibility Criteria

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

You may qualify if:

  • Daily smokers (5≥ cigarettes/day)
  • A low socio-economic position (meaning being unemployed or being a recipient of one of the state programs for low income individuals)
  • Being available for at least 4 appointments over a 6 month period
  • Affiliation to or benefiting from social security or state medical support

You may not qualify if:

  • Individuals who do not speak French, or who have cognitive impairments making it impossible to understand study information or a condition that makes it impossible for them to give informed consent.
  • Major citizens protected by law, adults unable to express their consent and subject to a protective measure (guardianship, curatorship, safeguard of justice)
  • Pregnant women or with a pregnancy project, mothers breastfeeding their child(ren).
  • Regular smokers who vape daily (at least once a day).
  • Patients who are already participating in another clinical study (self-reported).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

CHI Aix Pertuis

Aix-en-Provence, 13100, France

Location

CHU Angers

Angers, 49933, France

Location

Hôpital Avicenne

Bobigny, France

Location

Hôpital Jean Verdier

Bondy, France

Location

CH Le Vinatier

Bron, 69500, France

Location

HCL Est

Bron, 69500, France

Location

Hôpital Antoine Béclère

Clamart, 92140, France

Location

Institut Coeur Poumon - Lille

Lille, France

Location

Centre Municipal de Santé Savattero&Centre Municipal Daniel Renoult

Montreuil, 93100, France

Location

Association Addictions France

Nîmes, 30000, France

Location

Centre Hospitalier Sainte Anne

Paris, 75014, France

Location

Hôpital Tenon

Paris, 75020, France

Location

HCL Sud

Pierre-Bénite, 69310, France

Location

Centre de Santé Pierre-Rouquès

Villejuif, 94800, France

Location

HCL Centre

Villeurbanne, 69100, France

Location

Related Publications (1)

  • El-Khoury F, El Aarbaoui T, Heron M, Hejblum G, Metadieu B, Le Faou AL, Ibanez G, Melchior M. Smoking cessation using preference-based tools among socially disadvantaged smokers: study protocol for a pragmatic, multicentre randomised controlled trial. BMJ Open. 2021 Jun 30;11(6):e048859. doi: 10.1136/bmjopen-2021-048859.

    PMID: 34193499DERIVED

MeSH Terms

Conditions

SmokingSmoking CessationVaping

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

BehaviorHealth Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior researcher, principal investigator

Study Record Dates

First Submitted

November 27, 2020

First Posted

December 4, 2020

Study Start

February 26, 2021

Primary Completion

August 30, 2024

Study Completion

August 30, 2024

Last Updated

December 16, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(15)