Preference-based Tools for Smoking Cessation Among Disadvantaged Smokers, a Pragmatic Randomised Controlled Trial
Key facts
- Who runs it
- Société de Formation Thérapeutique du Généraliste - Recherche
- Where
- France15 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 167 people enrolled
- Started
- 26 Feb 2021
- Ended
- 30 Aug 2024
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- The STOP intervention
- Standard Care
- Record updated
- 16 December 2024
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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)
- People who at the time of inclusion are already being managed for smoking cessation (whatever treatment: varenicline, electronic cigarette, NRT, hypnosis, acupuncture, psychotherapy, talk groups, etc.)
- Patients who are already participating in another clinical study (self-reported)
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
- Objective:
Read full original descriptionShow less
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.
The 2 groups in the trial
- The STOP interventionTreatment being tested
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.
- Standard CareExisting treatment, for comparison
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.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Sevrage Tabagique à l'Aide Des Outils dédiés Selon la Préférence, un Essai randomisé contrôlé Pragmatique
- Record updated
- 16 December 2024