Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00158171
Status:
COMPLETED
Last Update Posted:
2017-01-10
First Post:
2005-09-08
Brief Title:
Effectiveness of Various Smoking Cessation Therapies in Reducing Smoking in Adolescents - 1
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
Interventions for Tobacco Dependent Adolescents
Status:
COMPLETED
Status Verified Date:
2016-10
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:
Currently one in five high school students smokes Smoking can harm adolescents well before they reach adulthood by causing a number of immediate sometimes irreversible health risks and problems This study will compare the effectiveness of treatment with bupropion a nicotine patch or nicotine gum in supporting the reduction of smoking in adolescent smokers
Detailed Description:
Among adolescents the short-term health effects of smoking include damage to the respiratory system addiction to nicotine and the associated risk of other drug use Adolescents are at greater risk for long-term health problems because most young people who smoke regularly continue to smoke throughout adulthood This study will compare the effectiveness of treatment with bupropion a nicotine patch or nicotine gum in supporting the reduction of smoking in adolescent smokers The study will also assess whether reduction of smoking leads to continued involvement in treatment less toxic cigarette exposure and improved motivation to quit
This open-label study will last a total of 6 weeks Baseline measurements will be taken twice a week at study visits for the first two weeks to assess vital signs and smoking behavior Participants will aslo use a computerized device outside of study visits to monitor their own smoking habits At Week 3 participants will be randomly assigned to receive bupropion a nicotine patch nicotine gum or placebo Participants will be asked to limit the frequency of their smoking to 75 of what it was during baseline During Weeks 4 5 and 6 participants will be expected to reduce smoking behavior to 50 of what it was at baseline Customized doses of nicotine patches and nicotine gum relative to the amount of cigarettes a participant smoked during baseline will be dispensed weekly Participants receiving bupropion or placebo will receive medication at each study visit and will take one pill daily During treatment study visits will occur once weekly At each study visit all participants will receive a 10- to 15-minute standardized behavioral therapy session aimed at supporting smoking reduction Smoking habits and vital signs will be assessed and the effects of the treatments will be determined There will be one follow-up visit 3 months post-intervention at which time smoking status will be assessed
This open-label study will last a total of 6 weeks Baseline measurements will be taken twice a week at study visits for the first two weeks to assess vital signs and smoking behavior Participants will aslo use a computerized device outside of study visits to monitor their own smoking habits At Week 3 participants will be randomly assigned to receive bupropion a nicotine patch nicotine gum or placebo Participants will be asked to limit the frequency of their smoking to 75 of what it was during baseline During Weeks 4 5 and 6 participants will be expected to reduce smoking behavior to 50 of what it was at baseline Customized doses of nicotine patches and nicotine gum relative to the amount of cigarettes a participant smoked during baseline will be dispensed weekly Participants receiving bupropion or placebo will receive medication at each study visit and will take one pill daily During treatment study visits will occur once weekly At each study visit all participants will receive a 10- to 15-minute standardized behavioral therapy session aimed at supporting smoking reduction Smoking habits and vital signs will be assessed and the effects of the treatments will be determined There will be one follow-up visit 3 months post-intervention at which time smoking status will be assessed
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 |
|---|---|---|---|
| DPMC | None | None | None |
| R01-14538-1 | None | None | None |