No single smoking cessation treatment has emerged as effective for all smokers. Although there has been a decline in the number of smokers, most remaining smokers, despite a professed desire to quit, have been unsuccessful in their efforts to do so. While various nicotine replacement products have shown promise as safe, effective adjunctive aids for dealing with the effects of withdrawal from nicotine, relapse rates are quite high once treatment is terminated. There is a great need for other cost effective and optimal treatment strategies for reducing this high relapse rate. Based on encouraging preliminary findings the use of a non-pharmacological agent, Accu Drop, plus brief motivational enhanced counseling may provide a novel set of conditions to potentially offer an optimal multi-modal smoking cessation treatment strategy to a wide range of smokers who are willing to undertake an active effort to address their smoking problem. Accu Drop is a corn syrup based food additive which is purported to trap nicotine and tar when applied to the filter of cigarettes. At the maximum dose, smoking machines have demonstrated a 88 percent-98 percent reduction in nicotine delivery. The proposed research is the first study to test the efficacy of the Accu Drop solution in combination with multimodal behavioral treatment. The 20-30 minute counseling sessions emphasize applying the drops as prescribed as well as creating an individualized schedule and plan of action for reducing cigarette usage leading toward total smoking cessation and maintenance by the end of treatment. The first objective of this proposed Innovative Stage 1B Behavioral Therapy Development Research project is to finalize a treatment manual for the counseling sessions that are provided in conjunction with Accu Drop use. A second objective of the research is to more fully systematize therapist training procedures for this treatment as well as quality assurance procedures to ensure treatment integrity. The final research objective is to conduct a preliminary study under randomized, double-blind, placebo controlled conditions, to evaluate the efficacy of a 6 week Accu Drop nicotine fading protocol used in conjunction with cigarette tapering to bring about termination of cigarette usage in moderate to heavy smokers (greater than or equal to 15 cpd) who are interested in smoking cessation. Both the experimental and control groups in this study will receive six weeks of the manually driven behavioral treatment by experienced and trained therapists. The experimental group (N=30) will also be prescribed active Accu Drops (AD and C) while the control condition (N=30) will be prescribed placebo Accu Drops (PD and C) very similar in appearance, viscosity, and taste to active Accu Drops. Completion of the study protocol and smoking cessation rates at 1 week, 1 month, and 6 months post-treatment will be the prime measures of efficacy. The findings of this study will provide sufficient evidence for the efficacy of the experimental treatment and its extended investigation in a Phase II study or for its nonefficacy.
