Single-arm feasibility study reports high acceptability and potential effectiveness in people with multiple sclerosis, suggesting future trials.
Background: People with multiple sclerosis (pwMS) who smoke have an increased risk of progression. MS-specific barriers make it more difficult to stop smoking. However, tailored smoking cessation programs for pwMS are non-existent. Objective: The aim of this study was to assess the feasibility of a newly developed MS-specific smoking cessation intervention. Design: This was a one-armed, uncontrolled, prospective feasibility study. The intervention consisted of five online group sessions over 3 weeks, with follow-up assessments 3 and 12 weeks after baseline. This study took place between December 2024 and September 2025. Methods: Recruitment was conducted via clinics and MS networks. Primary outcomes were demand, practicality, and acceptability. The potential effectiveness was a secondary outcome. Self-reported smoking status was assessed at both follow-ups. Smoking status for participants who were smoke-free at 12 weeks was verified by measuring cotinine levels in saliva samples. This study was pre-registered: https://drks.de/search/de/trial/DRKS00035557 . Results: With regard to demand, we screened 130 individuals from November 2024 to May 2025, with 99 found to be eligible. Of those enrolled ( n = 62), 48 started the intervention in 8 groups of 4–10 participants. With regard to practicality, 83% ( n = 40) completed the 3-week follow-up, and 77% ( n = 37) the 12-week follow-up. Acceptability was high, with all participants who completed the questionnaires ( n = 39) stating that they would recommend the program. Respectively, 48% ( n = 23) and 25% ( n = 12) of participants self-reported to be smoke-free at 3 and 12 weeks. We did not reach the target sample size of 60, and the dropout rate at 12 weeks ( n = 11, 23%) slightly exceeded our predefined 20% threshold. Conclusion: The intervention was well received. A randomized controlled trial to test its efficacy seems feasible, with improvements to recruitment strategies and by integrating participants’ feedback. Our findings suggest that tailored interventions may play an important role in addressing smoking cessation in people with other chronic or neurological conditions as well. Trial registration: This study was registered at the German Clinical Trials Register: DRKS00035557.
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Keller et al. (2026) studied this question.
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