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Completed

NCT Number: NCT00086411

Comparing Smoking Treatment Programs for Lighter Smokers - 1

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.

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Key information

Conditions

Tobacco Use Disorder Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104 6178, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nicotine transdermal system

Drug

starting with 21 or 14mg dependent on number of cigarettes per day smoked upon entry in the study; titrated down over 8 weeks.

Other names: Nicoderm

bupropion

Drug

150 mg/day X 3 days 300mg/day for 60 days Total 9 weeks

Other names: Zyban

Medication Management

Behavioral

Brief manual based therapy; four 15 minute session over 10 weeks.

Mayo Counseling

Behavioral

Manual based therapy; Weekly 30 minute sessions for 10 weeks

Placebo Patch

Drug

placebo patch containing no nicotine

Placebo Bupropion

Drug

placebo pills

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Comparing Smoking Treatment Programs for Lighter Smokers

Important dates

Study start
2003
Primary completion
2008
Study completion
2009
First posted
Jul 7, 2004
Registry last updated
Aug 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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