Comparing Smoking Treatment Programs for Lighter Smokers - 1 - Full Text View

Sponsor:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00086411

Purpose

The purpose of this study is 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.

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Comparing Smoking Treatment Programs for Lighter Smokers

Resource links provided by NLM:

MedlinePlus related topics: Quitting Smoking Smoking

Drug Information available for: Nicotine tartrate Bupropion hydrochloride Bupropion Nicotine polacrilex

U.S. FDA Resources

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

Primary Outcome Measures:

Completion of treatment and smoking cessation by two different types of medications and counseling types at 12, 26, and 52 weeks post-treatment initiation. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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
1: Bup+MM: Experimental bupropion and MM with placebo patch	Drug: bupropion 150 mg/day X 3 days 300mg/day for 60 days Total 9 weeks Behavioral: Medication Management Brief manual based therapy; four 15 minute session over 10 weeks. Drug: placebo patch placebo patch containing no nicotine
2 bup+mayo: Experimental bupropion and Mayo counseling with placebo patch.	Drug: bupropion 150 mg/day X 3 days 300mg/day for 60 days Total 9 weeks Behavioral: Mayo Counseling Manual based therapy; Weekly 30 minute sessions for 10 weeks Drug: placebo patch placebo patch containing no nicotine
3 patch+mm: Experimental patch and MM 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. Behavioral: Medication Management Brief manual based therapy; four 15 minute session over 10 weeks. Drug: placebo bupropion placebo pills
4 patch+mayo: Experimental patch and Mayo counseling with placebo patch	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. Behavioral: Mayo Counseling Manual based therapy; Weekly 30 minute sessions for 10 weeks Drug: placebo bupropion placebo pills

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00086411

Locations

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

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Peter W Gariti, Ph.D.

University of Pennsylvania

More Information

No publications provided

Responsible Party:	University of Pennsylvania ( Peter Gariti, PhD )
Study ID Numbers:	NIDA-15365-1, R01-15365-1
Study First Received:	July 1, 2004
Last Updated:	February 8, 2010
ClinicalTrials.gov Identifier:	NCT00086411 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):

light smokers, smoking cessation treatments, treatment satisfaction

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Agonists
Tobacco Use Disorder
Nicotinic Agonists
Physiological Effects of Drugs
Psychotropic Drugs
Disorders of Environmental Origin
Cholinergic Agents
Pharmacologic Actions

Mental Disorders
Nicotine
Autonomic Agents
Therapeutic Uses
Bupropion
Substance-Related Disorders
Ganglionic Stimulants
Dopamine Agents
Peripheral Nervous System Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on February 08, 2010