Extended Treatment for Smoking Cessation
Summary
Adult smokers (21-65) and adolescent smokers (18 - 21) years of age residing in Alameda and Santa Clara counties will serve as the target population for this study. A total of 400 smokers meeting eligibility criteria will be randomized. Treatment will include both open label and extended treatment phases. Randomization. Participants will be randomized to extended therapy or control conditions at baseline (prior to open label treatment) and the analysis will be intention-to-treat (ITT) to avoid the threat of selection bias. Primary hypothesis. Smokers randomized to receive CBT during extended treatment will have a higher prolonged abstinence rate (PA) at 52 week and 104 week follow-up than participants in the Supportive therapy Control treatment.
Description
During open label treatment, all receive CBT and zyban and nicotine patch. At week 10 those who continue to smoke will be switched to varenicline through week 26. At week 10 those who are abstinent and report low levels of craving and low levels of depression symptoms will be withdrawn from study medications. Those who are abstinent but report difficulty with craving or depression symptoms will remain on zyban and NRT through week 26. Medication will not be available after week 26. All will receive CBT through week 26.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Cigarette Smoking
Intervention
cognitive behavior therapy (CBT)
Status
Not yet recruiting
Source
National Institute on Drug Abuse (NIDA)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01067612
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Cognitive Dissonance
Motivational state produced by inconsistencies between simultaneously held cognitions or between a cognition and behavior; e.g., smoking enjoyment and believing smoking is harmful are dissonant.
Cognitive Therapy
A direct form of psychotherapy based on the interpretation of situations (cognitive structure of experiences) that determine how an individual feels and behaves. It is based on the premise that cognition, the process of acquiring knowledge and forming beliefs, is a primary determinant of mood and behavior. The therapy uses behavioral and verbal techniques to identify and correct negative thinking that is at the root of the aberrant behavior.
Cytochrome P-450 Cyp1a2
A cytochrome P-450 monooxygenase that can be induced by polycyclic aromatic xenobiotics in the liver of human and several animal species. This enzyme is of significant clinical interest due to the large number of drug interactions associated with its induction and its metabolism of THEOPHYLLINE. Caffeine is considered to be a model substrate for this enzyme. CYP1A2 activity can also be increased by environmental factors such as cigarette smoking, charbroiled meat, cruciferous vegetables, and a number of drugs including phenytoin, phenobarbital, and omeprazole.
Recreation Therapy
The enhancement of physical, cognitive, emotional and social skills so an individual may participate in chosen activities. Recreational modalities are used in designed intervention strategies, incorporating individual's interests to make the therapy process meaningful and relevant.
Smoking Cessation
Discontinuation of the habit of smoking, the inhaling and exhaling of tobacco smoke.
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