title: The focus and conduct of clinical trials.
abstract: This paper discusses some issues regarding how putative stop-smoking treatments should be evaluated. Preliminary evaluations of treatments have used withdrawal symptoms as a surrogate for abstinence in an attempt to decide those treatments on which to carry out expensive full-scale clinical trials. However, withdrawal symptom severity has not been shown to relate to long-term abstinence in any prospective studies. Until a better understanding of the relationship between withdrawal symptoms and abstinence is obtained withdrawal symptoms cannot be considered an appropriate surrogate for abstinence. Research is needed into what pattern of short-term abstinence provides the best predictor of long-term abstinence. Evidence from carbon monoxide validation of short-term abstinence raises doubts about whether minor lapses back to smoking are likely to lead to full blown relapse. Further research into the use of expired-air CO in validation of claims of abstinence is required. Finally, the traditional clinical trials format is not well suited to evaluation of treatment programmes with a large behavioural component. An alternative based on the principles underlying biological evolution is proposed.
authors.affiliation: Psychology Department, Royal Holloway and Bedford New College, London University, Egham, Surrey, UK.
authors.forename: R
authors.initials: R
authors.lastname: West
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods*; D003131:Combined Modality Therapy; D005500:Follow-Up Studies; D006801:Humans; D009538:Nicotine / Q000008:administration & dosage / Q000009:adverse effects*; D012907:Smoking / Q000009:adverse effects / Q000523:psychology / Q000628:therapy*; D013375:Substance Withdrawal Syndrome / Q000517:prevention & control* / Q000523:psychology
chemical_list: D009538:Nicotine