Completed

Comparing Smoking Treatment Programs for Lighter Smokers

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What is being tested

nicotine transdermal system

+ Medication Management

+ placebo bupropion

DrugBehavioral
Who is being recruted

Mental Disorders+1

+ Tobacco Use Disorder

+ Substance-Related Disorders

From 18 to 75 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: September 2003
See protocol details

Summary

Principal SponsorUniversity of Pennsylvania
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2003

Actual date on which the first participant was enrolled.

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.

Official TitleComparing Smoking Treatment Programs for Lighter Smokers 
NCT00086411
Principal SponsorUniversity of Pennsylvania
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

260 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersTobacco Use DisorderSubstance-Related DisordersChemically-Induced Disorders

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo
patch and MM counseling with placebo pills

Group II

Experimental
patch and Mayo counseling with placebo pills

Group III

Experimental
bupropion and MM counseling with placebo patch

Group IV

Experimental
bupropion and Mayo counseling with placebo patch.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of Pennsylvania

Philadelphia, United StatesSee the location
CompletedOne Study Center