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Comparing Smoking Treatment Programs for Lighter Smokers - 1

NCT00086411 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2019-08-06

Study results available
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Summary

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.

Conditions

  • Tobacco Use Disorder

Interventions

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.

DRUG

bupropion

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

BEHAVIORAL

Medication Management

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

BEHAVIORAL

Mayo Counseling

Manual based therapy; Weekly 30 minute sessions for 10 weeks

DRUG

placebo patch

placebo patch containing no nicotine

DRUG

placebo bupropion

placebo pills

Sponsors & Collaborators

Principal Investigators

  • Peter W Gariti, Ph.D. · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-09-30
Primary Completion
2008-04-30
Completion
2009-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00086411 on ClinicalTrials.gov