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Tailored Smoking Cessation Treatment for LIVE FOR LIFE® Participants (LiveForLife2)

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ClinicalTrials.gov Identifier: NCT01560507
Recruitment Status : Terminated (Low Recruitment)
First Posted : March 22, 2012
Results First Posted : November 19, 2013
Last Update Posted : December 24, 2014
Sponsor:
Collaborator:
Philip Morris USA, Inc.
Information provided by (Responsible Party):
Duke University

March 20, 2012
March 22, 2012
September 9, 2013
November 19, 2013
December 24, 2014
May 2012
July 2013   (Final data collection date for primary outcome measure)
Cost-effectiveness of the Adaptive Treatment Approach to Smoking Cessation [ Time Frame: End of study drug treatment period (11-12 weeks) ]
Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.
Cost-effectiveness of the Adaptive Treatment Approach to Smoking Cessation [ Time Frame: End of study drug treatment period (11-12 weeks) ]
Complete list of historical versions of study NCT01560507 on ClinicalTrials.gov Archive Site
Quit Success Genotype Score [ Time Frame: After 6 month Follow-Up ]
Study was terminated early due to difficulties with enrollment. No outcome measures were assessed."
Quit Success Genotype Score [ Time Frame: After 6 month Follow-Up ]
Not Provided
Not Provided
 
Tailored Smoking Cessation Treatment for LIVE FOR LIFE® Participants
Tailored Smoking Cessation Treatment for LIVE FOR LIFE® Participants
The purpose of this study is to ascertain: 1) the rate of smoking cessation obtained using an adaptive treatment algorithm developed in previous clinical trials, in order to calculate cost-effectiveness of the treatment; 2) the relationship between genotype and response to cigarette smoking cessation treatment.
Previous research has shown that the initial response to nicotine patch treatment can be used to decide whether the patch alone is likely to help smokers to quit or whether alternative prescription medications may be needed to achieve smoking abstinence. This study applies the knowledge gained from this previous research to adapt the smoking cessation treatment provided to participants, based on their degree of smoking reduction during the first four weeks of nicotine patch treatment. By demonstrating effectiveness of this algorithm, this study may lead to further dissemination of the adaptive treatment strategy to other health care settings. Additionally, by gathering further information relating genomic markers to outcome, the foundation will be laid for potential practical application of this index in other settings.
Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Cigarette Smoking
  • Nicotine Dependence
  • Drug: varenicline (Chantix)
    For the first 3 days after being switched from NRT (occurring at one week before the rescheduled quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks.
    Other Names:
    • Chantix
    • varenicline
  • Drug: bupropion (Zyban)
    After being switched from NRT (occurring at one week before the rescheduled quit date), smokers in this group will receive 150mg of bupropion once daily and 21mg nicotine patch for first 3 days; 150mg of bupropion twice daily and 21mg nicotine patch for 7 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks.
    Other Names:
    • Zyban
    • bupropion
  • Drug: nicotine patches
    21mg nicotine patch for first 11 weeks; 14mg nicotine patch for next 2 weeks; 7mg nicotine patch for final 2 weeks.
  • Active Comparator: varenicline (Chantix)
    This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation Nicotine Replacement Therapy (NRT) assessed the day before the scheduled quit day. They will receive varenicline.
    Intervention: Drug: varenicline (Chantix)
  • Active Comparator: nicotine patches
    This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They will continue to using only nicotine patches.
    Intervention: Drug: nicotine patches
  • Active Comparator: bupropion (Zyban) and nicotine patches
    This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They will receive bupropion with nicotine patches.
    Interventions:
    • Drug: bupropion (Zyban)
    • Drug: nicotine patches
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
19
300
July 2013
July 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Duke employees who are enrolled in a Duke Health Plan and intend to remain employed at Duke for the next six months;
  • Dependents of Duke employees who meet the above criteria;
  • 18-65 years old;
  • Currently smoke an average of at least 10 cigarettes per day;
  • Willing to take Chantix or Zyban;
  • Express a desire to quit smoking within the next 30 days.

Exclusion Criteria:

  • Hypertension;
  • Hypotension with symptoms (systolic <90 mm Hg, diastolic <60 mm Hg);
  • Coronary heart disease;
  • Lifetime history of heart attack;
  • Cardiac rhythm disorder (irregular heart rhythm);
  • Chest pains (unless history, exam, and ECG clearly indicate a non-cardiac source);
  • Cardiac (heart) disorder (including but not limited to valvular heart disease, heart murmur, heart failure);
  • Extensive active skin disorder;
  • Liver or kidney disorder (except kidney stones, gallstones);
  • Gastrointestinal disease other than gastroesophageal reflux or heartburn;
  • Active ulcers in the past 30 days;
  • Currently symptomatic lung disorder/disease (including but not limited to COPD, emphysema, and asthma);
  • Brain abnormality (including but not limited to stroke, brain tumor, and seizure disorder);
  • Migraine headaches that occur more frequently than once per week;
  • Recent, unexplained fainting spells;
  • 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 six months (except basal or squamous cell skin cancer);
  • Other major medical condition;
  • Suicidal ideation (within the past 10 years) or lifetime occurrence of attempted suicide;
  • Pregnant or nursing mothers;
  • Current psychiatric disease (with the exception of anxiety disorders, OCD and ADHD);
  • Current depression;
  • Bulimia or anorexia;
  • Alcohol abuse;
  • Significant adverse reaction to bupropion/Wellbutrin/Zyban, Chantix/Varenicline or nicotine patches in the past.
  • Use (within the past 30 days) of:

    • Wellbutrin, bupropion, Zyban, Chantix, nicotine replacement therapy or any other smoking cessation aid.
    • Medications that are known to affect smoking cessation.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01560507
Pro00032605
Yes
Not Provided
Not Provided
Duke University
Duke University
Philip Morris USA, Inc.
Principal Investigator: Jed E Rose, Ph.D. Duke University
Duke University
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP