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

This study has been terminated.
(Low Recruitment)
Sponsor:
Collaborator:
Philip Morris USA, Inc.
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01560507
First received: March 20, 2012
Last updated: September 9, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Cigarette Smoking
Nicotine Dependence
Drug: varenicline (Chantix)
Drug: bupropion (Zyban) & nicotine patches
Drug: nicotine patches
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tailored Smoking Cessation Treatment for LIVE FOR LIFE® Participants

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Cost-effectiveness of the Adaptive Treatment Approach to Smoking Cessation [ Time Frame: End of study drug treatment period (11-12 weeks) ] [ Designated as safety issue: No ]
    Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.


Secondary Outcome Measures:
  • Quit Success Genotype Score [ Time Frame: After 6 month Follow-Up ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: May 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
Drug: nicotine patches
21mg nicotine patch for first 11 weeks; 14mg nicotine patch for next 2 weeks; 7mg nicotine patch for final 2 weeks.
Other Name: 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.
Drug: bupropion (Zyban) & nicotine patches
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;
  • 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.
  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: NCT01560507

Locations
United States, North Carolina
Duke Center forSmoking Cessation
Durham, North Carolina, United States, 27705
Duke Center for Smoking Cessation
Raleigh, North Carolina, United States, 27609
Sponsors and Collaborators
Duke University
Philip Morris USA, Inc.
Investigators
Principal Investigator: Jed E Rose, Ph.D. Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01560507     History of Changes
Other Study ID Numbers: Pro00032605
Study First Received: March 20, 2012
Results First Received: September 9, 2013
Last Updated: September 9, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Varenicline
Bupropion
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014