Study Stopped
Low Recruitment
Tailored Smoking Cessation Treatment for LIVE FOR LIFE® Participants
LiveForLife2
1 other identifier
interventional
19
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 2012
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2012
CompletedFirst Posted
Study publicly available on registry
March 22, 2012
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedResults Posted
Study results publicly available
November 19, 2013
CompletedDecember 24, 2014
November 1, 2014
1.2 years
March 20, 2012
September 9, 2013
December 5, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Cost-effectiveness of the Adaptive Treatment Approach to Smoking Cessation
Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.
End of study drug treatment period (11-12 weeks)
Secondary Outcomes (1)
Quit Success Genotype Score
After 6 month Follow-Up
Study Arms (3)
varenicline (Chantix)
ACTIVE COMPARATORThis 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.
nicotine patches
ACTIVE COMPARATORThis 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.
bupropion (Zyban) and nicotine patches
ACTIVE COMPARATORThis 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
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.
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.
21mg nicotine patch for first 11 weeks; 14mg nicotine patch for next 2 weeks; 7mg nicotine patch for final 2 weeks.
Eligibility Criteria
You may qualify if:
- 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;
- 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.
You may not qualify if:
- 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;
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- Philip Morris USA, Inc.collaborator
Study Sites (2)
Duke Center forSmoking Cessation
Durham, North Carolina, 27705, United States
Duke Center for Smoking Cessation
Raleigh, North Carolina, 27609, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Early termination of the study because of recruitment difficulties lead to insufficient data collection and analysis of primary and secondary outcome measures.
Results Point of Contact
- Title
- Dr. Jed Rose
- Organization
- Duke University Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Jed E Rose, Ph.D.
Duke University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2012
First Posted
March 22, 2012
Study Start
May 1, 2012
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
December 24, 2014
Results First Posted
November 19, 2013
Record last verified: 2014-11