Study to Determine if a New Nicotine Replacement Therapy Can Safely Help Smokers to Quit Smoking

• Number of Participants With Continuous Smoking Abstinence [ Time Frame: through Week 6 ] [ Designated as safety issue: No ]
  Number of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking from Week 2 through Week 6.
  
  

• Number of Participants With Continuous Smoking Abstinence [ Time Frame: through Week 26 ] [ Designated as safety issue: No ]
  Number of participants with carbon monoxide (CO)-verified self report of continuous abstinence from smoking from Week 2 to Weeks 4, 6, 12, 16, and 26.
  
  
• Number of Participants With 7-day Point Prevalence Abstinence [ Time Frame: through Week 26 ] [ Designated as safety issue: No ]
  Number of participants with carbon monoxide (CO)-verified self-reported 7-day point prevalence abstinence from smoking at Weeks 2, 4, 6, 12, 16, and 26.
  
  
• Mean Number of Daily Doses [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
  Mean number of daily doses by study week.
  
  
• Mean Number of Daily Doses [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  Mean number of daily doses by study week.
  
  
• Mean Number of Daily Doses [ Time Frame: Week 3 ] [ Designated as safety issue: No ]
  Mean number of daily doses by study week.
  
  
• Mean Number of Daily Doses [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  Mean number of daily doses by study week.
  
  
• Mean Number of Daily Doses [ Time Frame: Week 5 ] [ Designated as safety issue: No ]
  Mean number of daily doses by study week.
  
  
• Mean Number of Daily Doses [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  Mean number of daily doses by study week.
  
  
• Percentage of Participants With High Dosage [ Time Frame: within 12 Weeks ] [ Designated as safety issue: No ]
  Percentage of participants who used more than 64 doses in any one-day period.
  
  
• Percentage of Participants With High Usage [ Time Frame: within 12 Weeks ] [ Designated as safety issue: No ]
  Percentage of participants who used more than four doses in any one-hour period.
  
  
• Highest Rating of Desire/Urge to Smoke on a Categorical Scale [ Time Frame: within 12 Weeks ] [ Designated as safety issue: No ]
  Participants are asked if during the last 24 hours they experienced the Desire/Urge to Smoke on a 5-grade categorical scale from Not at all to Extremely so.
  
  
• Highest Rating of Irritability/Frustration/Anger on a Categorical Scale [ Time Frame: within 12 Weeks ] [ Designated as safety issue: No ]
  Participants are asked if during the last 24 hours they experienced Irritability/Frustration/Anger on a 5-grade categorical scale from Not at all to Extremely so.
  
  
• Highest Rating of Restlessness on a Categorical Scale [ Time Frame: within 12 Weeks ] [ Designated as safety issue: No ]
  Participants are asked if during the last 24 hours they experienced Restlessness on a 5-grade categorical scale from Not at all to Extremely so.
  
  
• Highest Rating of Difficulty Concentrating on a Categorical Scale [ Time Frame: within 12 Weeks ] [ Designated as safety issue: No ]
  Participants are asked if during the last 24 hours they experienced Difficulty Concentrating on a 5-grade categorical scale from Not at all to Extremely so.
  
  
• Highest Rating of Anxiety on a Categorical Scale [ Time Frame: within 12 Weeks ] [ Designated as safety issue: No ]
  Participants are asked if during the last 24 hours they experienced Anxiety on a 5-grade categorical scale from Not at all to Extremely so.
  
  
• Highest Rating of Dysphoric or Depressed Mood on a Categorical Scale [ Time Frame: within 12 Weeks ] [ Designated as safety issue: No ]
  Participants are asked if during the last 24 hours they experienced Dysphoric or Depressed Mood on a 5-grade categorical scale from Not at all to Extremely so.
  
  
• Highest Rating of Insomnia on a Categorical Scale [ Time Frame: within 12 Weeks ] [ Designated as safety issue: No ]
  Participants are asked if during the last 24 hours they experienced Insomnia on a 5-grade categorical scale from Not at all to Extremely so.
  
  
• Highest Rating of Increased Appetite on a Categorical Scale [ Time Frame: within 12 Weeks ] [ Designated as safety issue: No ]
  Participants are asked if during the last 24 hours they experienced Increased Appetite on a 5-grade categorical scale from Not at all to Extremely so.
  
  
• Participant Score for General Perception of the Product [ Time Frame: through Week 12 ] [ Designated as safety issue: No ]
  Participants are asked to rate their general perception of the investigational product on a scale of 1-10, where 1=very poor and 10=excellent.
  
  
• Participant Score for Product Effectiveness in Dealing With Cravings [ Time Frame: through 12 Weeks ] [ Designated as safety issue: No ]
  Participants are asked to rate the product in its effectiveness for dealing with cravings, on a scale of 1-5, where 1=not at all effective, and 5=extremely effective.
  
  
• Participant Score for Speed of Action [ Time Frame: through 12 Weeks ] [ Designated as safety issue: No ]
  Participants are asked to rate the product for speed of action, on a scale of 1-9, where 1=extremely slow and 9=extremely fast.
  
  
• Participant Score for Change in Perception [ Time Frame: through 12 Weeks ] [ Designated as safety issue: No ]
  Participants are asked to rate how their opinion has changed since the first time they used it, on a score of 1-5, where 1=I like it much less now and 5=I like it much more now.
  
  
• Participant Score for Product Convenience [ Time Frame: through 12 Weeks ] [ Designated as safety issue: No ]
  Participants are asked to rate how convenient the product is to use, on a scale of 1-5, where 1=not at all convenient and 5=extremely convenient.
  
  

This trial is a multi-center, randomized, double blind, placebo-controlled parallel group study to measure the efficacy and safety of a new nicotine replacement therapy for smoking cessation in a naturalistic environment. Subjects will be randomized in a 2:1 ratio (active to placebo). It is anticipated that data from about 450 in the active treatment group at Week 12 will be required for the safety analysis. In order to obtain that number of subjects, approximately 1500 subjects will need to be enrolled into the Use phase of the study, 1000 in the active arm and 500 in the placebo arm.

Based on the directions for use on the Drug Facts label, the study will include six weeks of full study drug treatment and then six weeks of progressive tapering drug treatment (Weeks 1-12). There will be a 14-week post-use follow up period.

This trial will be conducted in three sequential phases: Enrollment (baseline), Use and Post-use Follow-up. The Enrollment Phase will be conducted in approximately 20 pharmacies in nine diverse geographical areas in the continental United States. Subjects who qualify to participate in the study will be given three units of investigational product, a subject diary for tracking investigational product use and a medical problems worksheet to assist in the collection of AE information. Subjects will also be given a small hand counter and will be encouraged to use it to help keep track of the number of doses they use each day. Subjects will also be given a card with contact information for the pharmacy and study nurses. Where needed, the subject can also speak with the study physician.

During the Use Phase, the collection of data related to efficacy will be accomplished during four return visits to the pharmacy (at weeks 2, 4, 6 and 12). Self-reported abstinence will be verified by carbon monoxide (CO) measurements obtained at each pharmacy visit. Subjects will be given a subject use diary at each follow-up and re-supply visit and completed diaries will be collected each time the subject returns to the pharmacy. Subjects can return to the pharmacy for additional supplies at any time during their participation. Empty units will be returned during these visits.

Safety data will be collected during four telephone interviews, conducted by trained nurse interviewers, at weeks 2, 4, 6 and 12. If a subject reports an adverse event during a visit (return visit or resupply visit), this information will be immediately forwarded to the nurse interviewers for follow-up. Subjects may also initiate a call to the study nurses themselves to discuss health problems. All AE information collected will be reviewed by a physician as the adverse events are collected. A standardized visual mouth examination will be conducted by trained dentists at the enrollment visit and at the Week 12 return visit.

During the Post-use Follow-up period, self-reported efficacy and safety data will be collected during two telephone interviews initiated by trained nurse interviewers (at weeks 16 and 26). Subjects reporting abstinence since the last visit or abstinence for the prior seven days during these two interviews will be asked to return to the pharmacy to verify abstinence with an exhaled CO measurement. An additional telephone interview will be conducted between Week-12 and Week-16, by trained nurse interviewers, who will administer the End of Treatment questions to those subjects who have reported the following product use behavior that are inconsistent with the directions on the Drug Facts label: Use of more than 64 doses in a 24-hour period at least one time or use of more than 4 doses per hour at least one time based on the diary or their self report.