Comparing Smoking Treatment Programs for Lighter Smokers - 1

University of Pennsylvania

Status and phase: Completed; Phase 2

Conditions: Tobacco Use Disorder

Treatments: Behavioral: Medication Management; Behavioral: Mayo Counseling; Drug: placebo patch; Drug: nicotine transdermal system; Drug: bupropion; Drug: placebo bupropion

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00086411

R01DA015365 (U.S. NIH Grant/Contract)

NIDA-15365-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 260 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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260 participants in 4 patient groups, including a placebo group

1: Bup+MM

Experimental group

Description:

bupropion and MM counseling with placebo patch

Treatment:

Drug: placebo patch

Drug: bupropion

Behavioral: Medication Management

2 Bup+Mayo

Experimental group

Description:

bupropion and Mayo counseling with placebo patch.

Treatment:

Drug: placebo patch

Drug: bupropion

Behavioral: Mayo Counseling

3 Patch+MM

Placebo Comparator group

Description:

patch and MM counseling with placebo pills

Treatment:

Drug: placebo bupropion

Drug: nicotine transdermal system

Behavioral: Medication Management

4 Patch+Mayo

Experimental group

Description:

patch and Mayo counseling with placebo pills

Treatment:

Behavioral: Mayo Counseling

Drug: placebo bupropion

Drug: nicotine transdermal system