Overview

This trial is active, not recruiting.

Condition smoking cessation
Treatment cognitive behavior therapy (cbt)
Sponsor Stanford University
Collaborator National Institute on Drug Abuse (NIDA)
Start date March 2010
End date March 2015
Trial size 400 participants
Trial identifier NCT01330043, NCT01067612, R01DA017441, SU-09272010-6949

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Participants will be randomized to receive extended cognitive behavioral therapy for an additional six months beyond the initial 26-week intervention. Those who do not receive extended cognitive behavioral therapy will receive a monthly phone call asking about their smoking status and will not receive any treatment.
cognitive behavior therapy (cbt)
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 At week 10 those who are abstinent and report low levels of craving and low levels of depression symptoms will be withdrawn from study medications.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.

Primary Outcomes

Measure
smoking abstinence
time frame: 52 and 104 week follow-up

Secondary Outcomes

Measure
smoking relapse
time frame: 52 and 104 week follow-up

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - Age at least 18 years at the beginning of the study Smoking at least 10 cigarettes a day (1/2 pack) Exclusion Criteria: 1. Currently pregnant 2. Currently breastfeeding 3. Currently diagnosed with a seizure disorder, major depression, liver disease, kidney disease, congestive heart failure or diabetes mellitus 4. History of a seizure, seizure disorder, significant head trauma or central nervous system tumor 5. Family history of seizures 6. Currently using intravenous drugs 7. Currently using any drugs (marijuana, alcohol, cocaine, opiates, stimulants, etc.) on a daily basis 8. Currently using any over-the-counter stimulants and anorectics (diet pills) 9. Currently on bupropion (Wellbutrin, Wellbutrin SR) or other antidepressants, monoamine oxidase inhibitors, antipsychotics, benzodiazepines, theophylline, systemic steroids or levodopa 10. Currently on NRT or bupropion (Zyban) 11. Current or past diagnosis of anorexia nervosa or bulimia nervosa 12. Previous allergic response to bupropion or NRT

Additional Information

Official title Extended Treatment for Smoking Cessation
Principal investigator Sean P. David, M.D., D.Phil.
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 nicotine replacement therapy (NRT) through week 26. Medication will not be available after week 26. All will receive CBT through week 26.
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by Stanford University.