Smoking Termination Enhancement Project (STEP)
Condition: Smoking
Intervention: Cognitive Behavioral Treatment; Nicotine Patch; Wellness Program; Aerobic Exercise
Intervention description: Cognitive Behavioral Treatment; Nicotine Patch; Wellness Program; Aerobic Exercise
Intervention MeSH terms: Nicotine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary aim of this research study (STEP) is to compare the effectiveness of two smoking
      cessation programs that integrate counseling and nicotine replacement with either a wellness
      program or exercise. This will help us to determine whether different lifestyle interventions
      (wellness or exercise) help increase the effectiveness of current standard programs for
      smoking cessation.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Aged between 18 and 65 years old

          2. Capable of providing informed consent, attend all study visits and comply with the
             protocol

          3. Daily smoker for at least one year and currently smoke an average of at least 10
             cigarettes per day

          4. Report a motivation to quit smoking in the next month of at least 5 on a 10-point
             scale

          5. Score of 20 or greater on 16-item Anxiety Sensitivity Index

          6. Physically inactive as defined as participating in moderate-intensity exercise less
             than 2 days/week (duration must be 30 minutes or less each time)

        Exclusion Criteria:

          1. Use of other tobacco products

          2. General medical condition(s) that contraindicate exercise

          3. Resting blood pressure of ≥ 160 systolic and/or 100 diastolic who are not receiving
             treatment for high blood pressure

          4. Blood lipid levels ≥ 240 mg/dl with LDL-C ≥ 160 mg/dl or triglyceride levels ≥ 300
             mg/dl (individuals receiving medical treatment for lipid abnormalities with lipid
             levels above the cut-offs will be eligible with physician written approval)

          5. Body mass index ≥40

          6. Currently suicidal or high suicide risk

          7. Current or past psychotic disorders of any type, or comorbid psychiatric conditions
             that are relative or absolute contraindications to the use of any treatment option in
             the study protocol

          8. Currently pregnant, planning on becoming pregnant in the next year, or current
             breastfeeding

          9. Alcohol or drug dependence; abuse of depressants, dissociative anesthetics,
             hallucinogens, opioids, or cocaine within the last 6 months

         10. Psychotherapy initiated within the past three months, or ongoing psychotherapy of any
             duration directed specifically toward the treatment of anxiety or mood disorder other
             than general supportive therapy

         11. Current use of any psychotherapy or pharmacotherapy for smoking cessation not provided
             by the researchers, including Chantix, Zyban, Welbutrin and Nortriptyline.