Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00063323
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2003-06-25
Brief Title:
Maintenance Treatment for Abstinent Smokers
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
Maintenance Treatment for Prevention of Smoking Relapse
Status:
COMPLETED
Status Verified Date:
2010-01
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:
The purpose of this study is to determine the efficacy and cost-effectiveness of long-term pharmacotherapy using Zyban andor nicotine replacement for reducing the relapse rate associated with stopping smoking
Detailed Description:
The goal of this study was to assess relapse prevention outcomes among individuals able to stop smoking when pharmacotherapy is extended beyond the standard duration of treatment We hypothesized that maintenance treatment with prolonged bupropion use andor as needed use of nicotine gum will reduce relapse to smoking Participants were recruited through advertisements on radio television newspapers the Internet and various community outlets Respondents were pre-screened by telephone using a standard interview The first participant entered the OLT phase in February 2001 the final NTFU visit took place in October 2005
The study was multi-phased consisting of 1 eight-week open-label treatment OLT with bupropion and nicotine patch 2 randomized double-blind assignment of OLT successes to 16 weeks of placebo-controlled maintenance treatment MT and 3 24 weeks of non-treatment follow-up NTFU Participants received 25 compensation for completing the NTFU visits at Weeks 36 and 48 The Institutional Review Board of the New York State Psychiatric Institute approved the study The study was performed at the Columbia University Medical Center Smoking Cessation Clinic in New York City
The study was multi-phased consisting of 1 eight-week open-label treatment OLT with bupropion and nicotine patch 2 randomized double-blind assignment of OLT successes to 16 weeks of placebo-controlled maintenance treatment MT and 3 24 weeks of non-treatment follow-up NTFU Participants received 25 compensation for completing the NTFU visits at Weeks 36 and 48 The Institutional Review Board of the New York State Psychiatric Institute approved the study The study was performed at the Columbia University Medical Center Smoking Cessation Clinic in New York City
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 | OTHER | NIDA | httpsreporternihgovquickSearchR01DA013490 |
| R01DA013490 | NIH | None | None |