Smoking CessationPhase 4GISCNCT02351167
Genetically Informed Smoking Cessation Trial
A Phase 4 study testing Combination NRT (Nicotine patch, Nicotine lozenge), Varenicline and Intensive smoking counseling in people with Smoking Cessation, run by Washington University School of Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Combination NRT (Nicotine patch, Nicotine lozenge), Varenicline and Intensive smoking counseling
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 822 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2015to 31 Aug 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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),
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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.
Read the detailed description
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.
- Conditions
- Smoking Cessation
- Being tested
- Combination NRT (Nicotine patch, Nicotine lozenge), Varenicline, Placebo, Intensive smoking counseling
- Keywords
- Smoking cessation, Counseling, Genetics and Genomics
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination NRT (Nicotine patch, Nicotine lozenge)Drug
Also called Nicoderm CQ, Nicotine Polacrilex Lozenge
VareniclineDrug
Also called Chantix
PlaceboDrug
Intensive smoking counselingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Combination NRT and Counseling | Active comparator | Combination Nicotine replacement therapy (cNRT) (patch and lozenge) and smoking cessation counseling will be provided to participants. Lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment. Receives: Drug: Combination NRT (Nicotine patch, Nicotine lozenge); Behavioral: Intensive smoking counseling |
| Varenicline (Chantix) and Counseling | Active comparator | Varenicline (pill) and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Seven smoking cessation counseling sessions will be given during treatment. Receives: Drug: Varenicline; Behavioral: Intensive smoking counseling |
| Placebo Medicine and Counseling | Placebo comparator | Placebo pill and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Placebo lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment. Receives: Drug: Placebo; Behavioral: Intensive smoking counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day Point Prevalence Quit Rate
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.
Measured: Week 12
Secondary outcomes (10)
Continuous Abstinence
The definition of this measure requires: Not taking even 1 cigarette puff from target quit date to end of treatment.
Measured: 12 weeks (with first 1 week initial grace period)
7-day Point Prevalence Quit Rate
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.
Measured: Week 24
Number of Days to Lapse
- 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
Measured: Assessed from the target quit day through 52 weeks
Number of Days to Relapse
- 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
Measured: Assessed from the target quit day through 52 weeks
Initial Cessation
Defined as at least 1 day of abstinence during the first 7 days after the target quit day.
Measured: Assessed for the first seven days after the target quit date
Longitudinal Models of Abstinence Outcomes Across Multiple Time Points
-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.
Measured: 0-52 Weeks
Longitudinal Models of Smoking Quantity in Cigarettes Per Day Outcomes Across Multiple Time Points.
The definition of this measure requires self-reported cigarettes per day.
Measured: 0-52 Weeks
Medication Adherence
Adherence is the proportion of expected medication (varenicline, patch, lozenge) taken as advised during pre-quit week to week 12
Measured: Pre-quit week to Week 12
Side Effects
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.
Measured: Pre-quit week to Week 12
Withdrawal
- 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.
Measured: Pre-quit, quit, week 1, week 2, and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2015 (estimated)
- Study start20 May 2015
- Primary completion26 Dec 2018
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 822 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Li-Shiun Chen, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02351167
- Sponsor's protocol ID
- 201305128
- Other IDs
- 1R01DA038076-01A1
- Acronym
- GISC
- Status last verified
- Sep 2020
- First submitted
- 26 Jan 2015
- Last updated
- 22 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen LS, Baker TB, Miller JP, Bray M, Smock N, Chen J, Stoneking F, Culverhouse RC, Saccone NL, Amos CI, Carney RM, Jorenby DE, Bierut LJ. Genetic Variant in CHRNA5 and Response to Varenicline and Combination Nicotine Replacement in a Randomized Placebo-Controlled Trial. Clin Pharmacol Ther. 2020 Dec;108(6):1315-1325. doi: 10.1002/cpt.1971. Epub 2020 Aug 4.
PubMed 32602170
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetically Informed Smoking Cessation Trial
- ClinicalTrials.gov ID
- NCT02351167
- Acronym / sponsor ID
- GISC / 201305128
- Conditions
- Smoking Cessation
- Keywords
- Smoking cessation, Counseling, Genetics and Genomics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 822 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Study start
- 20 May 2015 (actual)
- Primary completion
- 26 Dec 2018 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 30 Jan 2015 (estimated)
- Results
- Posted 16 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Combination NRT and Counseling | Active comparator | Drug: Combination NRT (Nicotine patch, Nicotine lozenge), Behavioral: Intensive smoking counselingCombination Nicotine replacement therapy (cNRT) (patch and lozenge) and smoking cessation counseling will be provided to participants. Lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment. |
| Varenicline (Chantix) and Counseling | Active comparator | Drug: Varenicline, Behavioral: Intensive smoking counselingVarenicline (pill) and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Seven smoking cessation counseling sessions will be given during treatment. |
| Placebo Medicine and Counseling | Placebo comparator | Drug: Placebo, Behavioral: Intensive smoking counselingPlacebo pill and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Placebo lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combination NRT (Nicotine patch, Nicotine lozenge)Also: Nicoderm CQ, Nicotine Polacrilex Lozenge | Drug | Combination NRT and Counseling |
| VareniclineAlso: Chantix | Drug | Varenicline (Chantix) and Counseling |
| Placebo | Drug | Placebo Medicine and Counseling |
| Intensive smoking counseling | Behavioural | Combination NRT and Counseling, Placebo Medicine and Counseling, Varenicline (Chantix) and Counseling |
Primary outcome
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.
10 secondary outcomes
Continuous Abstinence
Time frame: 12 weeks (with first 1 week initial grace period)
7-day Point Prevalence Quit Rate
Time frame: Week 24
Number of Days to Lapse
Time frame: Assessed from the target quit day through 52 weeks
Number of Days to Relapse
Time frame: Assessed from the target quit day through 52 weeks
Initial Cessation
Time frame: Assessed for the first seven days after the target quit date
Longitudinal Models of Abstinence Outcomes Across Multiple Time Points
Time frame: 0-52 Weeks
Longitudinal Models of Smoking Quantity in Cigarettes Per Day Outcomes Across Multiple Time Points.
Time frame: 0-52 Weeks
Medication Adherence
Time frame: Pre-quit week to Week 12
Side Effects
Time frame: Pre-quit week to Week 12
Withdrawal
Time frame: Pre-quit, quit, week 1, week 2, and week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32602170Chen LS, Baker TB, Miller JP, Bray M, Smock N, Chen J, Stoneking F, Culverhouse RC, Saccone NL, Amos CI, Carney RM, Jorenby DE, Bierut LJ. Genetic Variant in CHRNA5 and Response to Varenicline and Combination Nicotine Replacement in a Randomized Placebo-Controlled Trial. Clin Pharmacol Ther. 2020 Dec;108(6):1315-1325. doi: 10.1002/cpt.1971. Epub 2020 Aug 4.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li-Shiun Chen, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Combination NRT (Nicotine patch, Nicotine lozenge), Varenicline and Intensive smoking counseling in people with Smoking Cessation, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-day Point Prevalence Quit Rate (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02351167, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2020.