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Chantix & Bupropion for Smoking Cessation

NCT00587769 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2013-04-24

Study results available
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Summary

The overarching goal of this line of research is to increase smoking abstinence rates using a combination of existing pharmacotherapies. The aim of the current study is to assess the safety and compliance as well as obtain preliminary estimates of efficacy and effect on craving and nicotine withdrawal of combination therapy with bupropion SR and varenicline. We will compare the efficacy estimates in this study with historical smoking abstinence rates with varenicline. To accomplish our aims, we will enroll 38 cigarette smokers in an open-label, phase II clinical trial.

Conditions

  • Smoking
  • Tobacco Use Disorder

Interventions

DRUG

Bupropion SR & Varenicline

Bupropion SR 150 mg by mouth once day for 3 days then 150 mg by mouth twice per day. Varenicline 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.

Sponsors & Collaborators

Principal Investigators

  • Jon O Ebbert, MD · Mayo Clinic

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • United States

Study Locations

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Entities

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 NCT00587769 on ClinicalTrials.gov