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Combining a Smoke Ending Aid With Behavioral Treatment - 1

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00006151
First received: August 8, 2000
Last updated: June 16, 2010
Last verified: June 2010
History of Changes

August 8, 2000
June 16, 2010
May 1999
February 2008   (final data collection date for primary outcome measure)
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 ]
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Complete list of historical versions of study NCT00006151 on ClinicalTrials.gov Archive Site
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Combining a Smoke Ending Aid With Behavioral Treatment - 1
Combining a Smoke Ending Aid With Behavioral Treatment

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

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Tobacco Use Disorder
Behavioral: Behavioral Therapy
Weekly behavioural therapy based on MAYO clinic manual.
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
260
February 2008
February 2008   (final data collection date for primary outcome measure)

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
Both
21 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006151
NIDA-11645-1, R01-11645-1
Not Provided
Peter Gariti, Ph.D., University of Pennsylvania
National Institute on Drug Abuse (NIDA)
Not Provided
Principal Investigator: Peter W Gariti, Ph.D. University of Pennsylvania
National Institute on Drug Abuse (NIDA)
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP