Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00459953
Status:
COMPLETED
Last Update Posted:
2016-05-30
First Post:
2007-04-11
Brief Title:
Extended Cessation Treatment for Teen Smokers
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Extended Cessation Treatment for Teen Smokers
Status:
COMPLETED
Status Verified Date:
2016-05
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:
Nicoteens
Brief Summary:
This study is designed to test the efficacy of an extended smoking cessation program for teen smokers We hypothesize that teen smokers randomized to extended treatment will have a higher abstinence rate at 52 week follow-up than teen smokers receiving only open label treatment
Detailed Description:
Adolescent smokers aged 14-18 10 cigarettesday attending continuation high schools in the San Francisco-San Jose Bay Area will serve as the target population for this study 280 smokers meeting eligibility criteria will be randomized Our primary goal is to examine the effectiveness of a multi-factor extended treatment strategy in promoting longer-term smoking abstinence All 280 smokers will receive 10 weeks of open label treatment consisting of nicotine patch therapy and group-based intensive self-regulatory skills training ST Following open label treatment half n140 will receive nine additional group-based ST sessions delivered over a 14 week period Telephone counseling will also be provided in conjunction with an Interactive Voice Response system IVR that will allow early detection of smoking slips and rapid response by treatment staff The other half n140 will not receive any additional therapy beyond that provided in the open label treatment phase Abstinence and relapse will be assessed at the end of open label 10 weeks and extended treatment 24 weeks and at 52 weeks from the time of study entry Our primary hypothesis is that smokers randomized to extended treatment will have a higher prolonged abstinence rate PA at 52 week follow-up than participants receiving only open label treatment PA at 52 weeks will be the outcome measure used to evaluate the primary hypothesis and will be defined as a report of non-smoking following an initial 2-week grace period during which any smoking is not counted as a failure and an expired-air carbon monoxide level of 9PPM Here failure is defined as either seven consecutive days of smoking or smoking on at least one day on each of two consecutive weeks Point prevalence abstinence will be examined as a secondary outcome and defined as no smoking not even a puff for seven consecutive days prior to assessment and an expired-air carbon monoxide level of 9PPM With 150 participants per cell we will have in general 80 power at a 2-tailed alpha of 05 to detect a difference in abstinence rates of at least 15 over a large range of success probabilities
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 |
|---|---|---|---|
| R01CA118035 | NIH | None | httpsreporternihgovquickSearchR01CA118035 |