Nicotine Replacement Therapy (NRT) and Bupropion Mechanisms of Effectiveness in Smokers
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Intervention: Bupropion SR; Nicotine Patch; Placebo Patch and Placebo Pill
Intervention description: 150 encapsulated pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down.; Nicotine patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days; 150 encapsulated placebo pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down. Placebo patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days. The placebo patches were given beginning 1st day cessation: 21 mg size (but actually placebo)/24 days, 14 mg size (actually placebo)/ 14 mg size (actually placebo) 14 days/, 7 mg size (actually placebo)/7 days
Intervention MeSH terms: Bupropion; Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Enrollment: 197.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Electroencephalography; nicotine; bupropion; attention; drug withdrawal symptoms

Summary:

      The purpose of this study is to better characterize differences in mood, attention, brain
      activation patterns underlying the beneficial effects of pharmacological treatments
      previously demonstrated to be help individuals successfully quit tobacco smoking. Smokers
      will be randomly assigned to one of three treatments: 1) bupropion sustained release (SR), 2)
      nicotine patch, or 3) placebo patches plus pills across a 45-day period with a 3-week
      intensive post-treatment follow-up. In addition, 20 percent of the subjects will be
      randomized to a delayed-quit control group.
    

Eligibility criteria:

        Inclusion Criteria:Inclusion Criteria:

          -  Diagnostic and Statistical Manual of the American Psychiatric Association (DSM-IV)
             diagnosis of nicotine dependence with psychological dependence

          -  Smokes at least 10 cigarettes per day for the three months prior to enrollment

          -  Currently seeking treatment for nicotine dependence

          -  Medically healthy on the basis of physical examination and medical history, vital
             signs,

          -  Females must use an effective method of contraception for the duration of the study

        Exclusion Criteria:

          -  DSM-IV diagnosis of abuse or dependence on alcohol or drugs other than nicotine

          -  Current Axis I diagnosis or current treatment with psychotropic medications within the
             three months prior to enrollment

          -  History of schizophrenia or other psychotic disorders, bipolar disorder, or anxiety
             disorders

          -  Currently seeking treatment for nicotine disorders

          -  History of seizures or head trauma with loss of consciousness, brain contusion, or
             fracture

          -  History of significant recent violent behavior

          -  Blood pressure greater than 150/90

          -  History of eating disorders

          -  History of allergic reaction to any of the study medications

          -  Pregnant