Comparing Smoking Treatment Programs for Lighter Smokers - 1

NCT ID: NCT00086411

Last Updated: 2019-08-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2009-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Tobacco Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1: Bup+MM

bupropion and MM counseling with placebo patch

Group Type EXPERIMENTAL

bupropion

Intervention Type DRUG

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

Medication Management

Intervention Type BEHAVIORAL

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

placebo patch

Intervention Type DRUG

placebo patch containing no nicotine

2 Bup+Mayo

bupropion and Mayo counseling with placebo patch.

Group Type EXPERIMENTAL

bupropion

Intervention Type DRUG

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

Mayo Counseling

Intervention Type BEHAVIORAL

Manual based therapy; Weekly 30 minute sessions for 10 weeks

placebo patch

Intervention Type DRUG

placebo patch containing no nicotine

3 Patch+MM

patch and MM counseling with placebo pills

Group Type PLACEBO_COMPARATOR

nicotine transdermal system

Intervention Type DRUG

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

Medication Management

Intervention Type BEHAVIORAL

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

placebo bupropion

Intervention Type DRUG

placebo pills

4 Patch+Mayo

patch and Mayo counseling with placebo pills

Group Type EXPERIMENTAL

nicotine transdermal system

Intervention Type DRUG

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

Mayo Counseling

Intervention Type BEHAVIORAL

Manual based therapy; Weekly 30 minute sessions for 10 weeks

placebo bupropion

Intervention Type DRUG

placebo pills

Interventions

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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.

Intervention Type DRUG

bupropion

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

Intervention Type DRUG

Medication Management

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

Intervention Type BEHAVIORAL

Mayo Counseling

Manual based therapy; Weekly 30 minute sessions for 10 weeks

Intervention Type BEHAVIORAL

placebo patch

placebo patch containing no nicotine

Intervention Type DRUG

placebo bupropion

placebo pills

Intervention Type DRUG

Other Intervention Names

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Nicoderm Zyban

Eligibility Criteria

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Inclusion Criteria

Mentally and physically stable, non-pregnant, light smokers (6-15 cigarettes per day)

Exclusion Criteria

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Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter W Gariti, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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. doi: 10.1016/j.jsat.2007.08.009. Epub 2007 Oct 10.

Reference Type BACKGROUND
PMID: 17931823 (View on PubMed)

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. doi: 10.1016/j.jsat.2009.01.006. Epub 2009 Mar 31.

Reference Type RESULT
PMID: 19339135 (View on PubMed)

Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.

Reference Type DERIVED
PMID: 37230961 (View on PubMed)

Other Identifiers

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R01DA015365

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIDA-15365-1

Identifier Type: -

Identifier Source: org_study_id

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