title: Constructing a trial as a personal lifestyle change project: participants' experiences in a clinical study for nicotine vaccination.
abstract: The purpose of this study was to gain insight into the experiences and dynamics of the involvement of research participants in a randomized clinical trial for nicotine vaccination. Participants received an experimental nicotine vaccine or a placebo, in addition to quit smoking medication and counseling. The longitudinal design of this qualitative study allowed us to follow people from their first visit to the trial location until the unblinding of their treatment with either verum or placebo vaccine. The empirical data consisted of 49 semi-structured, in-depth interviews, field notes and memos, and trial documents collected in the Netherlands between 2010 and 2012. Participants' expectations and experiences of the innovative nicotine vaccine were characterized by ambivalence: Although they complied with the research design, throughout the study they tinkered with discourses, objects, and activities to make them serve their individual goals. They made the concepts of nicotine vaccination and placebo treatment meaningful for quitting, reshaped the meaning of research tests and obligatory visits to serve their own personal goals, and introduced a new element into the trial by creating space to discuss problems that might endanger the quit attempt. In short, the participants constructed the clinical study for nicotine vaccination as their own personal lifestyle change project.
authors.affiliation: Maastricht University, School CAPHRI, Department of Health, Ethics, and Society, P.O. Box 616, 6200 MD Maastricht, The Netherlands. Electronic address: a.wolters@maastrichtuniversity.nl.
authors.forename: Anna
authors.initials: A
authors.lastname: Wolters
authors.affiliation: Maastricht University, School CAPHRI, Department of Health, Ethics, and Society, P.O. Box 616, 6200 MD Maastricht, The Netherlands.
authors.forename: Guido
authors.initials: G
authors.lastname: de Wert
authors.affiliation: Maastricht University, School CAPHRI, Department of General Practice, P.O. Box 616, 6200 MD Maastricht, The Netherlands.
authors.forename: Onno
authors.initials: O
authors.lastname: van Schayck
authors.affiliation: Maastricht University, School CAPHRI, Department of Health, Ethics, and Society, P.O. Box 616, 6200 MD Maastricht, The Netherlands.
authors.forename: Klasien
authors.initials: K
authors.lastname: Horstman
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008019:Life Style; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D009538:Nicotine / Q000276:immunology*; D036301:Qualitative Research; D035842:Research Subjects / Q000523:psychology*; D012907:Smoking / Q000523:psychology; D016540:Smoking Cessation / Q000379:methods / Q000523:psychology; D000074606:Smoking Prevention; D014611:Vaccination; D014838:Volunteers / Q000523:psychology* / Q000706:statistics & numerical data
chemical_list: D009538:Nicotine
keywords: Constructing meaning; Expectations and experiences; Netherlands; Nicotine vaccine; Placebo; Quitting smoking; Randomized clinical trial; Research participants