Preference-based Tools for Smoking Cessation Among Disadvantaged Smokers, a Pragmatic Randomised Controlled Trial

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.

Conditions

• Smoking
• Smoking Cessation

Interventions

OTHER

The STOP intervention

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

Standard Care

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.

Sponsors & Collaborators

• National Cancer Institute, France

  collaborator OTHER_GOV

• Institut National de la Santé Et de la Recherche Médicale, France

  collaborator OTHER_GOV

• Société de Formation Thérapeutique du Généraliste - Recherche

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-02-26

Primary Completion

2024-08-30

Completion

2024-08-30

Countries

• France

Study Locations