An interventional study of tobacco smoking substitution products in HIV and Smoking, sponsored by University Hospital, Basel, Switzerland. Recruiting at 7 sites in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by University Hospital, Basel, Switzerland · Not applicable, Interventional, and Prevention
The purpose of this trial is to test the effectiveness of offering a menu of different tobacco smoking substitutional products (e-cigarettes, nicotine pouches, nicotine patches in addition to usual of care) for smokers in the SHCS (Swiss HIV Cohort Study) in achieving self-reported 7-day tobacco cigarette abstinence at 6 months.
Due to highly effective antiretroviral therapy, people living with HIV (PLWH) in Switzerland have a close-to-normal life expectancy. Among PLWH, there has been a shift of focus from HIV-related health issues to non communicable diseases, especially cardiovascular diseases (CVDs) and cancer. Smoking, a prominent risk factor for both diseases, takes a key role in view of the high number of smokers among PLWH.
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.
1,509 studies on the registry are indexed under Smoking; 193 are open to participants now.
This study's planned enrollment of 972 is above the median of 115 across 1,164 interventional studies indexed under Smoking.
Browse Smoking studies →University Hospital, Basel, Switzerland is the lead sponsor of 990 studies on the registry; 189 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Offer of preference-based smoking substitution menu, consisting of e-cigarettes or nicotine pouches or nicotine patches in addition to standard of care.
Other: tobacco smoking substitution products
Standard smoking cessation counselling according to routine care in the SHCS.
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.
Tobacco smoking status (yes/no)
Measured as self-reported abstinence in the last 7 day at 6-month visit
Time frame: at 6 month visit
Tobacco smoking status (yes/no)
Measured as self-reported abstinence in the last 7 day at 12-month visit and at 24-month visit
Time frame: at 12 month visit, 24-month visit
Mean change in number of tobacco-based cigarettes smoked per day
Number will be self reported by participant
Time frame: at 6 month visit, at 12 month visit, at 24 month visit
Mean Change in Cholesterol (mmol/l)
High Density Lipoprotein (HDL) and Low Density Lipoprotein (LDL) Cholesterol in blood samples will be measured
Time frame: at 6 month visit, at 12 month visit, at 24 month visit
Mean change in blood pressure (mmHg)
systolic and diastolic blood pressure will be measured.
Time frame: at 6 month visit, at 12 month visit, at 24 month visit
Mean change in body weight (kg)
Mean change in body weight from baseline to 6,12 and 24 months.
Time frame: at 6 month visit, at 12 month visit, at 24 month visit
Mean change in SCORE2-risk prediction algorithm
SCORE2: Algorithm to Predict Cardiovascular Disease Risk in Europe Linear regression model adjusted for the variables used in the minimization (region \[French vs. German speaking part of Switzerland\], men having sex with men \[yes/no\], current drug user \[yes/no\], number of cigarettes per day) and will be reported as an adjusted odds ratio with 95% confidence interval.
Time frame: at 6 month visit, at 12 month visit, at 24 month visit
Number of cardiovascular events
Occurrence of cardiovascular events (myocardial infarction, coronary angioplasty/stenting, coronary artery by-pass grafting, carotid endarterectomy, stroke, deep vein thrombosis, pulmonary embolism, heart transplantation) and all-cause death
Time frame: at 6 month visit, at 12 month visit, at 24 month visit
Serious Adverse events
This endpoint will be presented descriptively.
Time frame: at 6 month visit, at 12 month visit, at 24 month visit
Self reported use of any nicotine containing product other than tobacco cigarettes (yes/no)
Time frame: at 6 month visit, at 12 month visit, at 24 month visit
Self reported use of e-cigarettes (yes/no) or nicotine pouches (yes/no) or nicotine patches (yes/no)
Time frame: at 6 month visit, at 12 month visit, at 24 month visit
Self reported use of any nicotine containing product (yes/no)
Time frame: at 6 month visit, at 12 month visit, at 24 month visit
Not enrolling at this site.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan
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University Hospital, Basel, Switzerland →