The purpose of this study is to combine a smoke ending aid with behavioral treatment.

Condition	Treatment or Intervention	Phase
Tobacco Use Disorder	Behavior: Behavior Therapy	Phase IV

Further Study Details: 

Expected Total Enrollment:  60

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.

Ages Eligible for Study:  21 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

21 years of age or older, and no greater than65 years of age

Medically stable

Smoke at least 15 filtered cigarettes daily

Motivated to quit smoking

Exclusion Criteria:

Medically unstable

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

Pregnant

Pennsylvania
      University of Pennsylvania, Philadelphia,  Pennsylvania,  19104 6178,  United States

Study chairs or principal investigators

Peter W Gariti, Ph.D.,  Principal Investigator,  University of Pennsylvania   

Study ID Numbers:  NIDA-11645-1; R01-11645-1
Record last reviewed:  May 1999
Last Updated:  February 16, 2005
Record first received:  August 8, 2000
ClinicalTrials.gov Identifier:  NCT00006151
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08