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

This study has been terminated.
(Study terminated due to a technical issue (randomization error).)
Sponsor:
Collaborators:
McNeil AB
GlaxoSmithKline
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. )
ClinicalTrials.gov Identifier:
NCT01296698
First received: February 14, 2011
Last updated: March 29, 2012
Last verified: March 2012
  Purpose

This study is to see if a new nicotine replacement therapy safely helps people to quit smoking if it is used the way it would be if it were sold at the pharmacy and used at home. Approximately 1500 subjects will be enrolled into the study. The study will require participants to use the treatment for 12 weeks and there will be a 14-week follow-up period. The study will be conducted in approximately 20 pharmacies across the United States.

At the first visit to the pharmacy, participants will be asked some questions to see if they are eligible to participate. Participants will be asked to sign a consent form if they agree to participate. Participants will answer some more questions, and blow into a machine to measure their carbon monoxide (CO) levels to make sure they qualify for the trial. Participants will be asked to go to a nearby dentist who will look at their mouths. Participants will go back to the pharmacy and if they qualify, they will be given a supply of their assigned treatment. They will have an equal chance of receiving a treatment that has a drug in it or one that has no drug in it. They will be given a diary to keep track of how much of the treatment they use.

Subjects will go to the pharmacy four more times to hand in their diaries and blow into a machine that will measure their CO levels. At the last visit, subjects will have their mouths examined by a dentist again to have their mouth checked.

Subjects will receive four telephone calls during the study where they will be asked some questions.

After the 12 week treatment period, subjects will receive two to three more telephone calls, where they will be asked to answer some questions. Participants may be asked to come back to the pharmacy two more times to blow into the carbon monoxide machine again.


Condition Intervention Phase
Tobacco Dependence
Drug: Placebo
Drug: Nicotine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 26-Week Trial to Measure the Efficacy and Safety of a Novel Nicotine Replacement Therapy in Smokers in a Naturalistic Environment

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Consumer and Personal Products Worldwide:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 257
Study Start Date: March 2011
Study Completion Date: June 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
0 mg Oral NRT, up to 4 times per hour for 12 weeks
Drug: Placebo
Dosage Form: Oral NRT; Dose: 0 mg; Frequency: up to 4 times per hour; Duration: 12 weeks
Other Name: Not marketed
Experimental: Nicotine
1 mg Oral NRT, up to 4 times per hour for 12 weeks
Drug: Nicotine
Dosage Form: Oral NRT; Dose: 1 mg;Frequency: up to four times per hour; Duration:12 weeks
Other Name: Not yet marketed

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must be males or females 18 years of age or older who currently smoke cigarettes and are willing to stop smoking

Exclusion Criteria:

  • Subjects must not have a recent history of unstable angina, myocardial infarction or stroke
  • They must not have a suspected malignant and/or erosive oral lesion
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01296698

Locations
United States, Alabama
Avalon Discount Drugs
Muscle Shoals, Alabama, United States, 35661
United States, California
Coast Compounding Pharmacy
Oceanside, California, United States, 92054
United States, Georgia
Wynn's Pharmacy, Inc.
Griffin, Georgia, United States, 30224
United States, Kansas
Stark Pharmacy
Overland Park, Kansas, United States, 64116
United States, Minnesota
Goodrich Pharmacy
Anoka, Minnesota, United States, 55303
Goodrich Pharmacy
Elk River, Minnesota, United States, 55330
Goodrich Pharmacy
St. Francis, Minnesota, United States, 55070
Cub Pharmacy #1924
St. Louis Park, Minnesota, United States, 55426
United States, Mississippi
Medicap Pharmacy
Clarksdale, Mississippi, United States, 38614
Liddy's Health Mart
Holly Springs, Mississippi, United States, 38635
United States, Missouri
Countryside Pharmacy
Savannah, Missouri, United States, 64485
United States, New Mexico
Phil's Pills
Albuquerque, New Mexico, United States, 87110
United States, North Carolina
Kerr Drug
Raleigh, North Carolina, United States, 27609
United States, Pennsylvania
Family Prescription Center
Bethlehem, Pennsylvania, United States, 18015
United States, Texas
T.B. Bond Pharmacy
Hillsboro, Texas, United States, 76645
Inwood Pharmacy
Houston, Texas, United States, 77070
Louis Morgan Drug #1
Longview, Texas, United States, 75602
Brick Street Pharmacy
Tyler, Texas, United States, 75701
United States, Virginia
Montpelier Pharmacy, Inc.
Montpelier, Virginia, United States, 23192
Sponsors and Collaborators
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
McNeil AB
GlaxoSmithKline
Investigators
Study Director: Daniel Qi, MD McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
  More Information

No publications provided

Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. )
ClinicalTrials.gov Identifier: NCT01296698     History of Changes
Other Study ID Numbers: A6431112
Study First Received: February 14, 2011
Results First Received: March 29, 2012
Last Updated: March 29, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide:
Smoking Cessation
Tobacco Use Disorder

Additional relevant MeSH terms:
Nicotine
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014