Combining a Smoke Ending Aid With Behavioral Treatment - 1

The prime objective of this Innovative Stage I A/B Behavioral Therapy Development Research
project is to conduct a pilot study under randomized, double-blind, placebo controlled
conditions, to provide preliminary estimation of 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 (*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&C) while the control
condition (N=30) will be prescribed placebo Accu Drops (PD&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 preliminary indication for
the efficacy of the experimental treatment and its extended investigation in a Phase II
study or for its nonefficacy.

Inclusion Criteria:

- 21 years of age or older, and no greater than 65 years of age

- Medically stable

- Smoke at least 15 filtered cigarettes daily

- Motivated to quit smoking

Exclusion Criteria:

- Medically unstable

- Currently psychiatrically unstable (schizophrenia, unstable psychosis, untreated
major depression, active substance abuse within the past 6 months)

- Pregnant