Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
National Institute on Drug Abuse (NIDA) |
---|---|
Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00086411 |
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 |
Enrollment: | 260 |
Study Start Date: | September 2003 |
Estimated 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
|
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
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
United States, Pennsylvania | |
University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 6178 |
Principal Investigator: | Peter W Gariti, Ph.D. | University of Pennsylvania |
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: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00086411 |
Health Authority: | United States: Federal Government |
light smokers, smoking cessation treatments, treatment satisfaction |
Nicotine polacrilex Smoking Dopamine Nicotine Mental Disorders |
Tobacco Use Disorder Bupropion Substance-Related Disorders Disorders of Environmental Origin |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Cholinergic Agonists Molecular Mechanisms of Pharmacological Action Nicotinic Agonists Physiological Effects of Drugs Psychotropic Drugs Cholinergic Agents |
Pharmacologic Actions Autonomic Agents Therapeutic Uses Ganglionic Stimulants Dopamine Agents Peripheral Nervous System Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |