Extended Treatment for Smoking Cessation
Condition: Smoking Cessation
Intervention: Bupropion; Nicotine patch; Varenicline
Intervention description: 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 At week 10 those who are abstinent and reported low levels of craving and low levels of depression symptoms were withdrawn from study medications.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 At week 10 those who are abstinent and reported low levels of craving and low levels of depression symptoms were withdrawn from study medications.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 At week 10 those who are abstinent and reported low levels of craving and low levels of depression symptoms were withdrawn from study medications.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.
Intervention MeSH terms: Bupropion; Nicotine; Varenicline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
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)
Masking description: Behavioral therapists were blinded until the end of open-label treatment (26 weeks). Investigators were blinded to treatment assignment until the end of the study.
Enrollment: 223.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: smoking cessation intervention

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.
    

Eligibility criteria:

        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