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Comparing Smoking Treatment Programs for Lighter Smokers - 1

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00086411
First Posted: July 7, 2004
Last Update Posted: March 11, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Peter Gariti, University of Pennsylvania
  Purpose
The purpose of this study was to compare two different types of Food and Drug Administration (FDA) approved smoking cessation medications (nicotine patch or bupropion) used in conjunction with two levels of counseling. It was hypothesized that the higher level of counseling would have the highest rates of treatment completion and highest rates of abstinence.

Condition Intervention Phase
Tobacco Use Disorder Drug: nicotine transdermal system Drug: bupropion Behavioral: Medication Management Behavioral: Mayo Counseling Drug: placebo patch Drug: placebo bupropion Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparing Smoking Treatment Programs for Lighter Smokers

Resource links provided by NLM:


Further study details as provided by Peter Gariti, University of Pennsylvania:

Primary Outcome Measures:
  • Percent Treatment Sessions Attended [ Time Frame: 52 weeks ]

    Completion of Treatment and Smoking Cessation by Two Different Types of Medications and Counseling Types at 12, 26, and 52 Weeks Post-treatment Initiation. The counseling types were Medication Management (MM) and Mayo counseling models. MM counseling was a 4 session lower intensity counseling model and Mayo counseling was a 10 session higher intensity model.

    A twofold definition of treatment completion included both medication and counseling session adherence. Treatment completion was defined as consistently taking the active medication as prescribed (80%) of the time during the medication period and attending at least 7 of the 10 required High C sessions or 3 of the 4 Low C sessions. Participants had to meet both requirements to be designated as full treatment completers.

    Seven-day point prevalence abstinence was the primary measure of abstinence at follow-up Weeks 12, 24, and 52. Abstinence was confirmed by biochemical testing.



Secondary Outcome Measures:
  • Delineate Mediators Associated With Different Treatment Conditions (i.e., Medication Compliance, Participant Views of Self-help Written Materials and Counseling Type. [ Time Frame: 52 weeks ]

Enrollment: 260
Study Start Date: September 2003
Study Completion Date: June 2009
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1: Bup+MM
bupropion and MM counseling with placebo patch
Drug: bupropion
150 mg/day X 3 days 300mg/day for 60 days Total 9 weeks
Other Name: Zyban
Behavioral: Medication Management
Brief manual based therapy; four 15 minute session over 10 weeks.
Drug: placebo patch
placebo patch containing no nicotine
Experimental: 2 Bup+Mayo
bupropion and Mayo counseling with placebo patch.
Drug: bupropion
150 mg/day X 3 days 300mg/day for 60 days Total 9 weeks
Other Name: Zyban
Behavioral: Mayo Counseling
Manual based therapy; Weekly 30 minute sessions for 10 weeks
Drug: placebo patch
placebo patch containing no nicotine
Placebo Comparator: 3 Patch+MM
patch and MM counseling with placebo pills
Drug: nicotine transdermal system
starting with 21 or 14mg dependent on number of cigarettes per day smoked upon entry in the study; titrated down over 8 weeks.
Other Name: Nicoderm
Behavioral: Medication Management
Brief manual based therapy; four 15 minute session over 10 weeks.
Drug: placebo bupropion
placebo pills
Experimental: 4 Patch+Mayo
patch and Mayo counseling with placebo pills
Drug: nicotine transdermal system
starting with 21 or 14mg dependent on number of cigarettes per day smoked upon entry in the study; titrated down over 8 weeks.
Other Name: Nicoderm
Behavioral: Mayo Counseling
Manual based therapy; Weekly 30 minute sessions for 10 weeks
Drug: placebo bupropion
placebo pills

Detailed Description:
The study compared a minimal level counseling model to a higher level counseling model plus one of two types of FDA approved smoking cessation products (bupropion or the nicotine patch)used to achieve long term abstinence among lighter smokers. Each participant received both products under blinded conditions meaning that neither the participant nor the counselor knew which product was real or a placebo. The primary goal was to determine the combination or combinations of high or low intensity counseling and pharmacotherapy (either bupropion or the nicotine patch) that were most effective for lighter smokers. The main hypothesis was that higher level counseling would contribute to improved outcomes meaning that more counseling would be associated higher abstinence rates following the completion of treatment and at longer term follow-up.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Light smokers (6-15 cigarettes per day

Inclusion Criteria:

Mentally and physically stable, non-pregnant, light smokers (6-15 cigarettes per day)

Exclusion Criteria:

Please contact site for more information

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00086411


Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104 6178
Sponsors and Collaborators
Peter Gariti
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Peter W Gariti, Ph.D. University of Pennsylvania
  More Information

Publications:
Responsible Party: Peter Gariti, Sponsor-Investigator, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00086411     History of Changes
Other Study ID Numbers: NIDA-15365-1
R01DA015365 ( U.S. NIH Grant/Contract )
First Submitted: July 1, 2004
First Posted: July 7, 2004
Results First Submitted: June 24, 2013
Results First Posted: March 11, 2014
Last Update Posted: March 11, 2014
Last Verified: January 2014

Keywords provided by Peter Gariti, University of Pennsylvania:
light smokers, smoking cessation treatment programs

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Bupropion
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Agents
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors