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Tailored Smoking Cessation Treatment for LIVE FOR LIFE® Participants

NCT01560507 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2014-12-24

Study results available
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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.

Conditions

  • Cigarette Smoking
  • Nicotine Dependence

Interventions

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.

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.

DRUG

nicotine patches

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

Sponsors & Collaborators

Principal Investigators

  • Jed E Rose, Ph.D. · Duke University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01560507 on ClinicalTrials.gov