Chantix & Bupropion for Smoking Cessation - Study Results

Chantix & Bupropion for Smoking Cessation (ChanBan)

This study has been completed.

Study NCT00587769 Information provided by Mayo Clinic

First Received on December 21, 2007. Last Updated on December 28, 2010 History of Changes

Results First Received: October 5, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Smoking Tobacco Use Disorder
Intervention:	Drug: Bupropion SR & Varenicline

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patient's were recruited between 10 September, 2007 and 25 October, 2007 in the community surrounding the Mayo Clinic in Rochester Minnesota.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were excluded for not meeting entry criteria

Reporting Groups

	Description
Medication Arm	Varenicline 1.0 mg po bid plus bupropion 150 mg po bid

Participant Flow: Overall Study

Baseline Characteristics

Reporting Groups

	Description
Medication Arm	Varenicline 1.0 mg po bid plus bupropion 150 mg po bid

Baseline Measures

	Medication Arm
Number of Participants [units: participants]	38
Age [units: years] Median ± Standard Deviation	49.1 ± 12.4
Gender [units: participants]
Female	17
Male	21
Cigarettes per day [units: cigarettes per day] Mean ± Standard Deviation	19.9 ± 7.8

Outcome Measures

1. Primary:

Point Prevalence Smoking Abstinence at 12 Weeks: the Number of Patients Who Refrained From Smoking at 12 Weeks [ Time Frame: 12 weeks ]

Show Outcome Measure 1

2. Secondary:

Point Prevalence Smoking Abstinence at 6 Months: the Number of Patients Who Refrained From Smoking at 6 Months [ Time Frame: 6 months ]

Show Outcome Measure 2

Serious Adverse Events

Other Adverse Events

More Information

Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Jon O. Ebbert
Organization: Mayo Clinic
phone: 507-284-2511
e-mail: ebbert.jon@mayo.edu

No publications provided

Responsible Party:	Jon O. Ebbert, MD, Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00587769 History of Changes
Other Study ID Numbers:	07-003998
Study First Received:	December 21, 2007
Results First Received:	October 5, 2010
Last Updated:	December 28, 2010
Health Authority:	United States: Food and Drug Administration