Reduce Tobacco Use in People Living With HIV in Switzerland
NCT ID: NCT06789692
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
972 participants
INTERVENTIONAL
2025-02-20
2027-12-31
Brief Summary
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Detailed Description
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New approaches to smoking cessation focus on harm reduction by substituting tobacco cigarettes by less harmful alternatives. Conventional nicotine replacement therapy like nicotine patches is well established and effective against withdrawal symptoms after quitting. However, these products are exceptionally expensive and the missing "nicotine hit" often limits therapy adherence. The long-term abstinence rate remains low. Electronic cigarettes (e-cigarettes) and nicotine pouches as alternative nicotine replacement therapies have the potential to overcome these problems and are accessible.
E-cigarettes play a growing role in smoking cessation therapy. Evidence from randomized trials shows superiority over conventional nicotine replacement therapies, which is probably based on the better imitation of the smoking experience. Although e-cigarettes are not without concerns, there is consensus that they are significantly less harmful than tobacco cigarettes.
Tobacco-free nicotine pouches, delivering nicotine through oral mucosa, are a relatively novel option for nicotine substitution. Similar to e-cigarettes, nicotine pouches are relatively affordable and can address the limitation of poor imitation of the "nicotine hit" seen with traditional nicotine replacement therapy. To the best of our knowledge, no trials have investigated the potential of nicotine pouches for smoking cessation so far.
With this trial, the investigators also want to address frequent shortcomings of smoking cessation trials, such as restrictive inclusion criteria and highly controlled interventions, by RETUNE Version 1.1, January 06, 2025 10/45 offering a menu of different tobacco smoking substitutional products (e-cigarettes or nicotine pouches or nicotine patches) and by using a novel pragmatic trial design, the Trials within Cohorts (TwiCs) design. The investigators plan to recruit tobacco smokers in the Swiss HIV Cohort Study (SHCS), regardless of their willingness to quit. This so called "opt-out-approach" has been suggested as a new promising approach for smoking cessation trials to increase generalizability of the results. The TwiCs design optimally allows to implement and evaluate the "opt-out" approach embedded in the SHCS.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Smoking substitution menu
Offer of preference-based smoking substitution menu, consisting of e-cigarettes or nicotine pouches or nicotine patches in addition to standard of care.
tobacco smoking substitution products
Offer of preference-based smoking substitution menu, consisting of e-cigarettes or nicotine pouches or nicotine patches in addition to standard of care. This menu will be offered by the treating physician during the routine cohort visit and the participant can choose one product to test as an alternative to tobacco smoking. The products will be handed out directly after the consultation and are provided free of charge for 6 months.
Standard of care group
Standard smoking cessation counselling according to routine care in the SHCS.
No interventions assigned to this group
Interventions
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tobacco smoking substitution products
Offer of preference-based smoking substitution menu, consisting of e-cigarettes or nicotine pouches or nicotine patches in addition to standard of care. This menu will be offered by the treating physician during the routine cohort visit and the participant can choose one product to test as an alternative to tobacco smoking. The products will be handed out directly after the consultation and are provided free of charge for 6 months.
Eligibility Criteria
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Inclusion Criteria
* Signed informed consent to be randomized to future interventions (Randomization consent).
* Age 18 years or older.
* Smoked one or more tobacco cigarettes per day (smoking status = yes) at the time of enrolment.
Exclusion Criteria
* Pregnant women.
18 Years
ALL
No
Sponsors
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Swiss National Science Foundation
OTHER
Novartis Foundation for Medical-Biological Research
UNKNOWN
University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Matthias Briel, Prof.
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Basel, Switzerland
Alain Amstutz, Dr.
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Basel, Switzerland
Christof Schönenberger, Dr.
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Basel, Switzerland
Locations
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Cantonal Hospital St. Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland
University Hospital Lausanne
Lausanne, Canton of Vaud, Switzerland
Cantonal Hospital Aarau
Aarau, , Switzerland
University Hospital Basel
Basel, , Switzerland
Inselspital Bern
Bern, , Switzerland
University Hospital Geneva
Geneva, , Switzerland
University Hospital Zurich
Zurich, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Patrick Schmid, Dr.
Role: primary
Matthias Cavassini, Prof.
Role: primary
Alexandra Calmy, Prof.
Role: primary
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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2024-02417; ub25Briel
Identifier Type: -
Identifier Source: org_study_id
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