Clinical trial NCT01560507: Tailored Smoking Cessation Treatment for LIVE FOR LIFE® Participants
Official title: Tailored Smoking Cessation Treatment for LIVE FOR LIFE® Participants
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Cigarette Smoking
Nicotine Dependence
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Philip Morris USA, Inc.
First posted: 2012-03-22
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Cost-effectiveness of the Adaptive Treatment Approach to Smoking Cessation
timeFrame: End of study drug treatment period (11-12 weeks)
Secondary outcomes:
measure: Quit Success Genotype Score
timeFrame: After 6 month Follow-Up
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Center forSmoking Cessation
state: North Carolina
city: Raleigh
country: United States
facility: Duke Center for Smoking Cessation
state: North Carolina
Study officials:
affiliation: Duke University
name: Jed E Rose, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: