Extended Treatment for Smoking Cessation
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      During open label treatment, all receive CBT and bupropion 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      be withdrawn from study medications.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.
    

Intervention name(s): Bupropion; Nicotine patch; Varenicline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Both groups received the same pharmacotherapy per protocol. During open label treatment, all received CBT and bupropion and NRT patch. At week 10 those who continued to smoke were switched to varenicline through week 26. At week 10 those who are abstinent and reported low levels of craving and low levels of depression symptoms were withdrawn from study medications. Those who were abstinent but reported difficulty with craving or depression symptoms remained on bupropion and NRT through week 26. Medication was not available after week 26.; Both groups received the same pharmacotherapy per protocol. During open label treatment, all received CBT and bupropion and NRT patch. At week 10 those who continued to smoke were switched to varenicline through week 26. At week 10 those who are abstinent and reported low levels of craving and low levels of depression symptoms were withdrawn from study medications. Those who were abstinent but reported difficulty with craving or depression symptoms remained on bupropion and NRT through week 26. Medication was not available after week 26.; Both groups received the same pharmacotherapy per protocol. During open label treatment, all received CBT and bupropion and NRT patch. At week 10 those who continued to smoke were switched to varenicline through week 26. At week 10 those who are abstinent and reported low levels of craving and low levels of depression symptoms were withdrawn from study medications. Those who were abstinent but reported difficulty with craving or depression symptoms remained on bupropion and NRT through week 26. Medication was not available after week 26.
Other intervention name(s): Zyban; NRT; Chantix
Intervention MeSH terms: Bupropion; Nicotine; Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were randomized to extended or non-extended treatment and followed for 104 weeks.
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
Keywords: smoking cessation intervention