Treatment of Nicotine Dependence and Acute Depression

This study has been completed.

Sponsor:

Collaborator:

GlaxoSmithKline

Information provided by (Responsible Party):

Alan Schatzberg, Stanford University

ClinicalTrials.gov Identifier:

NCT00186446

First received: September 13, 2005

Last updated: February 15, 2017

Last verified: February 2017

History of Changes

Results First Received: October 18, 2016

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Conditions:	Major Depressive Disorder Nicotine Dependence
Intervention:	Drug: bupropion and smoking cessation behavioral intervention

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Bupropion and Smoking Cessation Behavioral Intervention	Medication for depression and behavioral intervention for smoking cessation

Participant Flow: Overall Study

	Bupropion and Smoking Cessation Behavioral Intervention
STARTED	20
COMPLETED	11
NOT COMPLETED	9

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Bupropion and Smoking Cessation Behavioral Intervention	No text entered.

Baseline Measures

	Bupropion and Smoking Cessation Behavioral Intervention
Overall Participants Analyzed [Units: Participants]	20

Age [Units: Years] Mean (Standard Deviation)	44.35 (10.0)

Sex: Female, Male [Units: Participants] Count of Participants
Female	10 50.0%
Male	10 50.0%

Race (NIH/OMB) [Units: Participants] Count of Participants
American Indian or Alaska Native	0 0.0%
Asian	2 10.0%
Native Hawaiian or Other Pacific Islander	0 0.0%
Black or African American	0 0.0%
White	17 85.0%
More than one race	0 0.0%
Unknown or Not Reported	1 5.0%

Region of Enrollment [Units: Participants] Count of Participants
United States	20

Outcome Measures

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1. Primary:

Hamilton Depression Scale Score [ Time Frame: baseline to week 10 ]

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2. Primary:

Cessation of Smoking [ Time Frame: Week 10 ]

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3. Primary:

Can Depression and Smoking Cessation be Treated Simultaneously [ Time Frame: Dropouts over course of study ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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
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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:

Name/Title: aimee-noelle swanson
Organization: Stanford University
phone: 650-736-4559
e-mail: aimnoe@stanford.edu

Responsible Party:	Alan Schatzberg, Stanford University
ClinicalTrials.gov Identifier:	NCT00186446 History of Changes
Other Study ID Numbers:	GSK 103341
Study First Received:	September 13, 2005
Results First Received:	October 18, 2016
Last Updated:	February 15, 2017

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