Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00248118
Status:
TERMINATED
Last Update Posted:
2016-09-23
First Post:
2005-11-01
Brief Title:
Efficacy and Safety of Bupropion for Treatment of Adolescent Smoking
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Neurocognitive and Affective Correlates of Tobacco Dependence in Adolescent Smokers and Efficacy and Safety of Bupropion for Treatment of Adolescent Smoking
Status:
TERMINATED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI left NIH
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine 1 the short-term clinical efficacy and safety of bupropion for helping adolescent tobacco smokers quit and 2 The role of withdrawal symptoms in the maintenance of smoking in adolescents
Detailed Description:
This 10-week study consists of an unassisted pretrial acute tobacco withdrawal AW phase and a 7-week randomized double-blind placebo-controlled trial of bupropion 300 mgday for tobacco dependence Neuropsychological examinations will be conducted at baseline during acute withdrawal and during treatment incl early withdrawal with bupropion We expect smoking cessation in approximately 25 of the active medication group and significant overall smoking reduction We postulate that bupropion will also reduce the irritability depressed mood and anxiety symptoms that typically occur during tobacco withdrawal We expect to observe optimal cognitive performance ie attention memory and affective state during satiety impairment during pre-treatment abstinence and intermediate level cognitive performance in the abstinent active-treatment group Because limited data are available on cognitive tasks in adolescent smokers a non-smoking group will be included in order to establish the validity and appropriateness of our paradigm with a normative sample
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-DA-N382 | None | None | None |