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

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 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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
Experimental: 1: Bup+MM bupropion and MM 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
Experimental: 3 patch+mm 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. 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 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. Other Name: nicoderm 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

Publications:

Gariti P, Lynch K, Alterman A, Kampman K, Xie H, Varillo K. Comparing smoking treatment programs for lighter smokers with and without a history of heavier smoking. J Subst Abuse Treat. 2009 Oct;37(3):247-55. Epub 2009 Mar 31.

Gariti P, Levin S, Whittingham T, Barou D, Kampman KM, Lynch K, Halbert CH, Alterman A. Why do those who request smoking treatment fail to attend the first appointment? J Subst Abuse Treat. 2008 Jul;35(1):62-7. Epub 2007 Oct 10.

Responsible Party:	Peter Gariti, PhD, University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT00086411 History of Changes
Other Study ID Numbers:	NIDA-15365-1, R01-15365-1
Study First Received:	July 1, 2004
Last Updated:	June 16, 2010
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:

Smoking
Tobacco Use Disorder
Habits
Substance-Related Disorders
Mental Disorders
Nicotine
Bupropion
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists

Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013