Extended Treatment for Smoking Cessation
| Status: | Archived |
|---|---|
| Conditions: | Smoking Cessation |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | March 2010 |
| End Date: | March 2014 |
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.
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withdrawn from study medications.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.
We found this trial at
1
site
Stanford university Hospital and Clinics Throughout our history, we have pioneered medical advances that save...
Click here to add this to my saved trials
