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Combining a Smoke Ending Aid With Behavioral Treatment - 1
This study has been completed.
Sponsored by: National Institute on Drug Abuse (NIDA)
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00006151
  Purpose

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


Condition Intervention Phase
Tobacco Use Disorder
Behavioral: Behavioral Therapy
Phase IV

MedlinePlus related topics: Smoking
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Combining a Smoke Ending Aid With Behavioral Treatment

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • To determine the combination or combinations of pharmacotherapy (either bupropion or the nicotine patch) and either high or low intensity adjunctive counseling (Mayo vs. medical management) that are most effective as well as cost-effective. [ Time Frame: 1 year ]

Enrollment: 260
Study Start Date: May 1999
Study Completion Date: February 2008
Intervention Details:
    Behavioral: Behavioral Therapy
    Weekly behavioural therapy based on MAYO clinic manual.
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006151

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104 6178
Sponsors and Collaborators
Investigators
Principal Investigator: Peter W Gariti, Ph.D. University of Pennsylvania
  More Information

Responsible Party: University of Pennsylvania ( Peter Gariti, Ph.D. )
Study ID Numbers: NIDA-11645-1, R01-11645-1
Study First Received: August 8, 2000
Last Updated: October 27, 2008
ClinicalTrials.gov Identifier: NCT00006151  
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Smoking
Mental Disorders
Tobacco Use Disorder
Substance-Related Disorders
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on January 16, 2009