Tailored Smoking Cessation Treatment for LIVE FOR LIFE® Participants
Overview
- Phase
- Phase 2
- Intervention
- varenicline (Chantix)
- Conditions
- Cigarette Smoking
- Sponsor
- Duke University
- Enrollment
- 19
- Locations
- 2
- Primary Endpoint
- Cost-effectiveness of the Adaptive Treatment Approach to Smoking Cessation
- Status
- Terminated
- Last Updated
- 11 years ago
Overview
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.
Detailed Description
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.
Investigators
Eligibility Criteria
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;
Arms & Interventions
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: varenicline (Chantix)
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: nicotine patches
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.
Intervention: bupropion (Zyban)
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.
Intervention: nicotine patches
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Quit Success Genotype Score(After 6 month Follow-Up)