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

Primary Purpose

Cigarette Smoking, Nicotine Dependence

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
varenicline (Chantix)
bupropion (Zyban)
nicotine patches
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cigarette Smoking

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Duke Center forSmoking Cessation
  • Duke Center for Smoking Cessation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

varenicline (Chantix)

nicotine patches

bupropion (Zyban) and nicotine patches

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Cost-effectiveness of the Adaptive Treatment Approach to Smoking Cessation
Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.

Secondary Outcome Measures

Quit Success Genotype Score
Study was terminated early due to difficulties with enrollment. No outcome measures were assessed."

Full Information

First Posted
March 20, 2012
Last Updated
December 5, 2014
Sponsor
Duke University
Collaborators
Philip Morris USA, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01560507
Brief Title
Tailored Smoking Cessation Treatment for LIVE FOR LIFE® Participants
Acronym
LiveForLife2
Official Title
Tailored Smoking Cessation Treatment for LIVE FOR LIFE® Participants
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Terminated
Why Stopped
Low Recruitment
Study Start Date
May 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Philip Morris USA, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cigarette Smoking, Nicotine Dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
varenicline (Chantix)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
nicotine patches
Arm Type
Active Comparator
Arm Description
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.
Arm Title
bupropion (Zyban) and nicotine patches
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
varenicline (Chantix)
Other Intervention Name(s)
Chantix, varenicline
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
bupropion (Zyban)
Other Intervention Name(s)
Zyban, bupropion
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
nicotine patches
Intervention Description
21mg nicotine patch for first 11 weeks; 14mg nicotine patch for next 2 weeks; 7mg nicotine patch for final 2 weeks.
Primary Outcome Measure Information:
Title
Cost-effectiveness of the Adaptive Treatment Approach to Smoking Cessation
Description
Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.
Time Frame
End of study drug treatment period (11-12 weeks)
Secondary Outcome Measure Information:
Title
Quit Success Genotype Score
Description
Study was terminated early due to difficulties with enrollment. No outcome measures were assessed."
Time Frame
After 6 month Follow-Up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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; 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jed E Rose, Ph.D.
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Center forSmoking Cessation
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Duke Center for Smoking Cessation
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States

12. IPD Sharing Statement

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Tailored Smoking Cessation Treatment for LIVE FOR LIFE® Participants

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