Viewing Study NCT00129272



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Last Modification Date: 2024-10-26 @ 9:13 AM
Study NCT ID: NCT00129272
Status: COMPLETED
Last Update Posted: 2017-05-22
First Post: 2005-08-04

Brief Title: Effectiveness of Bupropion for Treating Nicotine Dependence in Young People
Sponsor: National Institute on Drug Abuse NIDA
Organization: National Institute on Drug Abuse NIDA

Study Overview

Official Title: Stress Response and Smoking Cessation in Depressed Youth
Status: COMPLETED
Status Verified Date: 2017-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Little is known about the best ways to help young people stop smoking Bupropion a medication marketed as Wellbutrin or Zyban has proved helpful in treating adult smokers The purpose of this study is to determine if bupropion is also effective in treating smokers between the ages of 12 and 25 years old This study also compares the effectiveness of bupropion used as a supplement to behavioral treatment versus behavioral treatment used alone In addition the study evaluates whether hormonal response to stress measured prior to the start of treatment predicts whether individuals respond well to treatment with medication
Detailed Description: Cigarette smoking and other forms of tobacco exposure are one of the leading preventable causes of morbidity and mortality in the United States Most smokers begin smoking during adolescence and though they seem motivated to quit smoking they frequently fail Although behavioral treatments are available they have not been very successful in past studies

Depressed adults may have more difficulty quitting smoking than non depressed adults this finding may also apply to depressed youth The purpose of this study is to determine the effectiveness of bupropion in combination with standard behavioral treatment in helping young smokers quit as compared to behavioral treatment alone Finally the study examines whether hormonal response to stress measured prior to treatment initiation predicts whether individuals respond well to treatment with bupropion

Participants in this double-blind study will be randomly assigned to receive either bupropion or placebo Both groups will receive behavioral treatment The trial will last for 9 weeks with weekly study visits Study visits will last 30 minutes to 1 hour and will include medication monitoring self-reported and biological measures of smoking and behavioral treatment Participants will have follow-up visits six months after completion of treatment

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None