Constructing a trial as a personal lifestyle change project: Participants' experiences in a clinical study for nicotine vaccination

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.