CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 260 enrolled
Drug / intervention
nicotine transdermal system +5 moredrug
Likely dose
Nicotine transdermal system 21 or 14 mg starting dose titrated down over 8 weeks, or bupropion 300 mg/day for 60 daysAI-extracted
Key inclusion· 3
  • Light smokers smoking 6-15 cigarettes per day
  • Mentally and physically stable
  • Non-pregnant
Key exclusion· 0

None specified.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00086411
NCT00086411Phase 2Completed

Comparing Smoking Treatment Programs for Lighter Smokers

University of Pennsylvania·interventional·Posted Jul 7, 2004·Updated Aug 6, 2019

In Brief

A Phase 2 clinical trial evaluating nicotine transdermal system, bupropion, and 4 other interventions for Tobacco Use Disorder. Completed, enrolled 260 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 7, 2004
Enrollment StartSep 1, 2003
Primary CompletionApr 1, 2008
Study CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 22.0 years ago

Interventions

nicotine transdermal systemdrug

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

bupropiondrug

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

Medication Managementbehavioral

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

Mayo Counselingbehavioral

Manual based therapy; Weekly 30 minute sessions for 10 weeks

placebo patchdrug

placebo patch containing no nicotine

placebo bupropiondrug

placebo pills