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Completed

NCT Number: NCT02351167

Genetically Informed Smoking Cessation Trial

The investigators' goal is to identify the most appropriate smoking cessation treatments for smokers based on genetic information. Smokers try to quit smoking but relapses are common.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

The investigators' goal is to determine whether genetic markers can be used to optimize smoking cessation pharmacotherapy to enhance efficacy, medication adherence, and reduce side effects. Smoking is a leading cause of preventable death and disability, and smoking cessation reverses the risk of mortality. However, cessation failure is common despite available cessation medications, which are associated with different efficacy, side effects, adherence, use constraints, and costs. This challenge can be addressed by improving current treatments via personalized medicine based on individual genetic markers to maximize efficacy and minimize side effects.

The investigators propose a prospective, genotype-based stratified randomization trial to compare two smoking cessation medications (combination NRT [patch and lozenge], varenicline vs. placebo) for 3 months in 720 smokers with known genotypes.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult (≥21 years of age), seeking treatment for smoking cessation.
  • Able to speak English,
  • Active smoking (Cigarettes Per Day (CPD) ≥5), and exhaled Carbon Monoxide (CO) ≥8 ppm
  • Agree to participate in this randomized smoking cessation trial with follow up assessments up to 12 months.

Exclusion criteria

  • Pregnancy or breast feeding,
  • Active use or recent use (< or equal to 1 month) of medication or e-cigarettes for nicotine dependence/smoking cessation, or use of e-cigarettes for more than 9 days in the prior month,
  • Allergy to nicotine patch, lozenge, or varenicline,
  • Unwillingness to prevent pregnancy during the medication phase and 1 month afterwards (women only),
  • Significant cardiac conditions (myocardial infarction, unstable angina, coronary angioplasty, cardiac bypass) or serious arrhythmia in past 6 months,
  • Current heavy alcohol consumption (≥6 drinks/day, 6 days/week),
  • Active psychosis or poorly controlled depression within the past 6 months,
  • Any prior suicide attempt or suicidal ideation within the past 6 months,
  • End stage renal disease with hemodialysis.

Treatment and study plan

Combination NRT (Nicotine patch, Nicotine lozenge)

Drug

Other names: Nicoderm CQ, Nicotine Polacrilex Lozenge

Varenicline

Drug

Other names: Chantix

Placebo

Drug

Intensive smoking counseling

Behavioral

Primary outcomes

  1. 7-day Point Prevalence Quit Rate

    Time frame: Week 12

    The definition of this measure requires: (a) no self-reported smoking (not even a puff of a cigarette) for at least the 7 days prior to the assessment, and (b) biochemical verification of abstinence.

Secondary outcomes

  1. Continuous Abstinence

    Time frame: 12 weeks (with first 1 week initial grace period)

    The definition of this measure requires: Not taking even 1 cigarette puff from target quit date to end of treatment.

  2. 7-day Point Prevalence Quit Rate

    Time frame: Week 24

    The definition of this measure requires: (a) no self-reported smoking (not even a puff of a cigarette) for at least the 7 days prior to the assessment, and (b) biochemical verification of abstinence.

  3. Number of Days to Lapse

    Time frame: Assessed from the target quit day through 52 weeks

    • The number of days to lapse is defined as the number of days from the target quit date until the participant reports smoking (even a single puff).
    • Participants who did not lapse by the end of the 52 weeks and participants who had missing information on lapse are not included in the overall number of participants analyzed

  4. Number of Days to Relapse

    Time frame: Assessed from the target quit day through 52 weeks

    • The number of days to relapse is defined as the number of days from the target quit day until the first of seven consecutive days of smoking.
    • Participants who did not relapse by the end of the 52 weeks and participants who had missing information on relapse are not included in the overall number of participants analyzed

  5. Initial Cessation

    Time frame: Assessed for the first seven days after the target quit date

    Defined as at least 1 day of abstinence during the first 7 days after the target quit day.

  6. Longitudinal Models of Abstinence Outcomes Across Multiple Time Points

    Time frame: 0-52 Weeks

    -The definition of this measure requires; no self-reported smoking (not even a puff of a cigarette) for at least 7 days prior to the assessment.

  7. Longitudinal Models of Smoking Quantity in Cigarettes Per Day Outcomes Across Multiple Time Points.

    Time frame: 0-52 Weeks

    The definition of this measure requires self-reported cigarettes per day.

  8. Medication Adherence

    Time frame: Pre-quit week to Week 12

    Adherence is the proportion of expected medication (varenicline, patch, lozenge) taken as advised during pre-quit week to week 12

  9. Side Effects

    Time frame: Pre-quit week to Week 12

    All reported side effects (occurring>4%) will be summarized and presented for the study. In addition, the investigators will further identify a pre-specified set of key side effects as being related to drug agonist effects (e.g., nausea, vomiting, racing heart, headache, and sleep disturbance). These will be analyzed as rate of occurrence during the period of medication use.

  10. Withdrawal

    Time frame: Pre-quit, quit, week 1, week 2, and week 4

    • Withdrawal severity is assessed by Wisconsin Smoking Withdrawal Scale (WSWS), there are 28 items.
    • Participants rate each item on a scale of 0-4 (0=Strongly disagree, 1=Disagree, 2=Feel neutral, 3=Agree, 4=Strongly agree). The subscale to each item is determined on how high they agree on the scale. For some items, the subscale is determined on how low they agreed. Each score is determined by the mean of each item that applies. Higher means indicate greater withdrawal.
    • The scores were calculated by averaging a mean score of each item for each participant with data from time point pre-quit, quit, week 1, week 2, and week 4. The mean score for each participant was averaged for each item and a mean score was taken for each treatment condition (cNRT, Varenicline, Placebo). These data are reported as mean withdrawal scores and not change in withdrawal scores.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • National Institutes of Health (NIH)

Registry information

Acronym: GISC

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Jan 30, 2015
Registry last updated
Sep 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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