Tailored Smoking Cessation Treatment for LIVE FOR LIFE® Participants

NCT ID: NCT01560507

Last Updated: 2014-12-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2013-07-31

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.

Conditions

Cigarette Smoking; Nicotine Dependence

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

varenicline (Chantix)

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

nicotine patches

Intervention Type: DRUG

21mg nicotine patch for first 11 weeks; 14mg nicotine patch for next 2 weeks; 7mg nicotine patch for final 2 weeks.

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.

Group Type: ACTIVE_COMPARATOR

bupropion (Zyban)

Intervention Type: DRUG

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.

nicotine patches

Intervention Type: DRUG

21mg nicotine patch for first 11 weeks; 14mg nicotine patch for next 2 weeks; 7mg nicotine patch for final 2 weeks.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

nicotine patches

21mg nicotine patch for first 11 weeks; 14mg nicotine patch for next 2 weeks; 7mg nicotine patch for final 2 weeks.

Intervention Type: DRUG

Other Intervention Names

Chantix; varenicline; Zyban; bupropion

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Philip Morris USA, Inc.

INDUSTRY

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jed E Rose, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke Center forSmoking Cessation

Durham, North Carolina, United States

Duke Center for Smoking Cessation

Raleigh, North Carolina, United States

Countries

United States

Other Identifiers

Pro00032605

Identifier Type: -

Identifier Source: org_study_id