Comparing Smoking Treatment Programs for Lighter Smokers - 1

July 25, 2019 updated by: University of Pennsylvania

Comparing Smoking Treatment Programs for Lighter Smokers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

260

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1: Bup+MM
bupropion and MM counseling with placebo patch
Drug: bupropion
150 mg/day X 3 days 300mg/day for 60 days Total 9 weeks
Other Names:
  • 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 Names:
  • Zyban
Drug: placebo patch
placebo patch containing no nicotine
Behavioral: Mayo Counseling
Manual based therapy; Weekly 30 minute sessions for 10 weeks
Placebo Comparator: 3 Patch+MM
patch and MM counseling with placebo pills
Behavioral: Medication Management
Brief manual based therapy; four 15 minute session over 10 weeks.
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 Names:
  • Nicoderm
Drug: placebo bupropion
placebo pills
Experimental: 4 Patch+Mayo
patch and Mayo counseling with placebo pills
Behavioral: Mayo Counseling
Manual based therapy; Weekly 30 minute sessions for 10 weeks
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 Names:
  • Nicoderm
Drug: placebo bupropion
placebo pills

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
52 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Peter W Gariti, Ph.D., University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

July 1, 2004

First Submitted That Met QC Criteria

July 6, 2004

First Posted (Estimate)

July 7, 2004

Study Record Updates

Last Update Posted (Actual)

August 6, 2019

Last Update Submitted That Met QC Criteria

July 25, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-15365-1
  • R01DA015365 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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