Concurrent Nicotine Patch / Denicotinized Cigarette Therapy for Smoking Cessation II
Condition: Cigarette Smoking
Intervention: Nicotine Patch
Intervention description: Groups 1 & 3 1-21mg Nicotine patch and 1-placebo for 2 wks pre quit day and 4 wks post quit day
Groups 2 & 4 2-21mg Nicotine Patches for 2 wks pre quit day and 4 wks post quit day
Intervention MeSH terms: Nicotine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 479.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cigarette; Nicotine

Summary:

      The main goals of the study are to assess benefits of higher doses of the nicotine patch
      prior to smoking cessation for high- and low-dependent smokers, and to investigate the
      potential relationship between genetic factors and smoking cessation success. There will be a
      two-week double-blind pre-cessation exposure to nicotine patch treatment in a sample of 240
      high-dependent & 240 low-dependent smokers; half of each group will wear two 21mg nicotine
      patches (42mg) daily, and half will wear one 21mg nicotine patch and one comparable placebo
      patch daily, resulting in the following four conditions (120 subjects each) during the 2-week
      pre-quit period: 1) Less Dependent/21mg nic., 2) Less Dependent/42mg nic., 3) More
      Dependent/21mg nic., and 4) More Dependent/42mg nic. After the quit date, subjects will
      continue with the same nicotine dosage for the 1st 4 weeks; after that the treatment will no
      longer be double-blind as only nicotine patches will be used: all subjects will wear one
      21-mg patch daily for 2 weeks, one 14-mg patch daily for the following 2 weeks, and one 7-mg
      patch for the remaining 2 weeks. The four treatment groups will be distributed over 4 sites:
      Durham, Raleigh, Charlotte, and Winston-Salem. After the screening visit, subjects will have
      7 lab visits: at 2 weeks, 1 week, and 1 day prior to the quit-smoking date, and at 1 week, 3
      weeks, 6 weeks and 10 weeks after the quit-smoking date.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must be 18-65 years old, have smoked an average of at least 10 cigarettes per
             day for three cumulative or continuous years of a brand that delivers (by Federal
             Trade Commission rated yields) at least 0.5 mg nicotine, have an expired air carbon
             monoxide reading of at least 10 ppm, and express a desire to quit smoking.
             Additionally, subjects must express a willingness to switch to denicotinized
             cigarettes. A more dependent smoker is defined as someone with an FTND score of seven
             or greater. A less dependent smoker is defined as someone with an FTND score of less
             than seven.

        Exclusion Criteria:

          -  For those with a known history of hypertension, systolic >140 mm Hg, diastolic >100 mm
             Hg); hypotension (systolic <90 mm Hg, diastolic <60 mm Hg) Participants with
             hypertension or hypotension may, however, be allowed to participate in the study if
             the study physician or P.A. determines that the condition is stable, controlled by
             medication, and in no way jeopardizes the individual's safety. Subjects with no
             previous diagnosis of hypertension may have a screening blood pressure up to 160/100.
             Potential subjects who report coronary heart disease; heart attack; cardiac rhythm
             disorder (irregular heart rhythm); chest pains (unless history, exam, and EKG clearly
             indicate a non-cardiac source); cardiac (heart) disorder (including but not limited to
             valvular heart disease, heart murmur, heart failure); history of skin allergy; active
             skin condition (psoriasis) within the last five years; skin disorder except minor skin
             conditions (including but not limited to facial acne, minor localized infections, and
             superficial minor wounds.); liver or kidney disorder (except kidney stones,
             gallstones); gastrointestinal problems or disease other than gastroesophageal reflux
             or heartburn; ulcers; lung disorder (including but not limited to COPD, emphysema, and
             asthma); brain abnormality (including but not limited to, stroke, brain tumor, seizure
             disorder); history of fainting; problems giving blood samples; difficulty passing
             urine; diabetes treated with insulin, non-insulin treated diabetes (unless glucose is
             less than 180mg/dcl and HbA1c is less than 7%); current cancer or treatment for cancer
             in the past 6 months(except basal or squamous cell skin cancer); other major medical
             condition; current psychiatric disease (with the exception of depression, anxiety
             disorders, OCD and ADHD) will be excluded from the study. Potential subjects who do
             not have a self reported diagnosis of the above listed conditions may be excluded if
             the study physician or P.A. determines that the history, physical findings, EKG, or
             laboratory studies reveal information that may jeopardize the subject's safe study
             participation.

        Potential subjects who have abused alcohol or drugs, or have used within the last 30 days
        experimental (investigational) drugs, psychiatric medications (including antidepressants,
        anti-psychotics) or any other medications that are known to affect smoking cessation (e.g.
        clonidine) will be excluded. Potential subjects who have used smokeless tobacco (chewing
        tobacco, snuff), cigars, pipes, nicotine replacement therapy, or other smoking cessation
        treatment within the last 2 weeks will be excluded. Pregnant or nursing mothers will be
        excluded.

        Use of non-opiate medications for pain or sleep will be allowed. For medical conditions
        that do not appear above, the study physician will be consulted and if the medical
        condition does not jeopardize safe study participation, then the subject may be enrolled.