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Clinical Trial Summary

Our primary goal is to examine the effectiveness of a multi-factor maintenance treatment strategy in promoting longer-term smoking abstinence. We will also conduct secondary analyses of mediators and moderators of treatment response.


Clinical Trial Description

400 adult smokers will be randomized. Our primary goal is to examine the effectiveness of a multi-factor maintenance treatment strategy in promoting longer-term smoking abstinence. All smokers will receive the same "Acute Phase Treatment" that combines nicotine patch, bupropion and intensive self-regulatory skills training. Nicotine patches will be provided for 8 weeks and bupropion and skills training will be provided for of 9 weeks. Participants will then enter a "Maintenance Treatment Phase" during which half (n=200) will receive three individualized relapse prevention training sessions spread over a 12 week period. They will also receive 12 weeks of self-administered RPT administered via written treatment modules. Finally, telephone counseling will 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 (n=200) will be assigned to a control condition that consists of three counselor-led sessions of "supportive therapy" spread over a 12 week period. P ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00110825
Study type Interventional
Source National Institute on Drug Abuse (NIDA)
Contact
Status Completed
Phase N/A
Start date February 2004
Completion date June 2009

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