Who is sponsoring NCT02351167?

NCT02351167 is sponsored by Washington University School of Medicine.

What drugs are being tested in NCT02351167?

Interventions in NCT02351167: Combination NRT (Nicotine patch, Nicotine lozenge), Varenicline, Placebo, Intensive smoking counseling.

What condition does NCT02351167 study?

NCT02351167 studies Smoking Cessation.

Is NCT02351167 still recruiting?

NCT02351167 is currently completed. Last updated 22 September 2020.

Are results published for NCT02351167?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-09-22 · How we verify

NCT02351167: GISC

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Genetically Informed Smoking Cessation Trial

Completed Phase 4 Results posted Last updated 22 September 2020

What this trial tests

Phase 4 trial testing Combination NRT (Nicotine patch, Nicotine lozenge) in Smoking Cessation in 822 participants. Completed in 31 August 2019.

Timeline

20 May 2015

Primary endpoint
26 December 2018

31 August 2019

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	822
Start date	20 May 2015
Primary completion	26 December 2018
Estimated completion	31 August 2019
Sites	1 location across United States

Drugs / interventions tested

Combination NRT (Nicotine patch, Nicotine lozenge) — full drug profile →
Varenicline (varenicline) — full drug profile →
Placebo
Intensive smoking counseling

Conditions studied

Smoking Cessation — all drugs for Smoking Cessation →

Sponsor

Washington University School of Medicine

Who can join

21 and older, any sex, with Smoking Cessation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

7-day Point Prevalence Quit Rate Primary · 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.

Group	Value	95% CI
Combination NRT and Counseling	55
Varenicline (Chantix) and Counseling	70
Placebo Medicine and Counseling	24

Continuous Abstinence Secondary · 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.

Group	Value	95% CI
Combination NRT and Counseling	43
Varenicline (Chantix) and Counseling	46
Placebo Medicine and Counseling	21

7-day Point Prevalence Quit Rate Secondary · 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.

Group	Value	95% CI
Combination NRT and Counseling	37
Varenicline (Chantix) and Counseling	56
Placebo Medicine and Counseling	25

Number of Days to Lapse Secondary · 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

Group	Value	95% CI
Combination NRT and Counseling	16.78	± 2.48
Varenicline (Chantix) and Counseling	20.47	± 3.22
Placebo Medicine and Counseling	11.85	± 2.07
3 Arms Combined	16.33	± 1.52

Number of Days to Relapse Secondary · 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

Group	Value	95% CI
Combination NRT and Counseling	44.83	± 4.25
Varenicline (Chantix) and Counseling	45.01	± 5.04
Placebo Medicine and Counseling	28.87	± 3.75
3 Arms Combined	39.22	± 2.53

Initial Cessation Secondary · 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.

Group	Value	95% CI
Combination NRT and Counseling	217
Varenicline (Chantix) and Counseling	186
Placebo Medicine and Counseling	172

Longitudinal Models of Abstinence Outcomes Across Multiple Time Points Secondary · 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.

0 weeks - Abstinence

Group	Value	95% CI
Combination NRT and Counseling	5
Varenicline (Chantix) and Counseling	3
Placebo Medicine and Counseling	0
3 Arms Combined	8

1 week - Abstinence

Group	Value	95% CI
Combination NRT and Counseling	91
Varenicline (Chantix) and Counseling	94
Placebo Medicine and Counseling	70
3 Arms Combined	255

2 week - Abstinence

Group	Value	95% CI
Combination NRT and Counseling	119
Varenicline (Chantix) and Counseling	105
Placebo Medicine and Counseling	70
3 Arms Combined	294

4 week - Abstinence

Group	Value	95% CI
Combination NRT and Counseling	112
Varenicline (Chantix) and Counseling	114
Placebo Medicine and Counseling	74
3 Arms Combined	300

12 week - Abstinence

Group	Value	95% CI
Combination NRT and Counseling	81
Varenicline (Chantix) and Counseling	88
Placebo Medicine and Counseling	49
3 Arms Combined	218

26 week - Abstinence

Group	Value	95% CI
Combination NRT and Counseling	75
Varenicline (Chantix) and Counseling	82
Placebo Medicine and Counseling	49
3 Arms Combined	206

52 week - Abstinence

Group	Value	95% CI
Combination NRT and Counseling	68
Varenicline (Chantix) and Counseling	77
Placebo Medicine and Counseling	43
3 Arms Combined	188

Longitudinal Models of Smoking Quantity in Cigarettes Per Day Outcomes Across Multiple Time Points. Secondary · 0-52 Weeks

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

0 week

Group	Value	95% CI
Combination NRT and Counseling	2.50	± 0.38
Varenicline (Chantix) and Counseling	2.95	± 0.32
Placebo Medicine and Counseling	3.74	± 0.38
3 Arms Combined	3.06	± 0.21

1 week

Group	Value	95% CI
Combination NRT and Counseling	3.06	± 0.40
Varenicline (Chantix) and Counseling	3.18	± 0.34
Placebo Medicine and Counseling	4.46	± 0.37
3 Arms Combined	3.56	± 0.22

2 week

Group	Value	95% CI
Combination NRT and Counseling	3.43	± 0.39
Varenicline (Chantix) and Counseling	3.08	± 0.35
Placebo Medicine and Counseling	5.00	± 0.41
3 Arms Combined	3.83	± 0.22

4 week

Group	Value	95% CI
Combination NRT and Counseling	4.08	± 0.43
Varenicline (Chantix) and Counseling	3.63	± 0.41
Placebo Medicine and Counseling	5.79	± 0.43
3 Arms Combined	4.49	± 0.25

12 week

Group	Value	95% CI
Combination NRT and Counseling	6.38	± 0.53
Varenicline (Chantix) and Counseling	5.75	± 0.50
Placebo Medicine and Counseling	8.33	± 0.52
3 Arms Combined	3.50	± 0.30

26 week

Group	Value	95% CI
Combination NRT and Counseling	7.68	± 0.58
Varenicline (Chantix) and Counseling	7.09	± 0.53
Placebo Medicine and Counseling	9.38	± 0.57
3 Arms Combined	8.03	± 0.32

52 week

Group	Value	95% CI
Combination NRT and Counseling	7.67	± 0.59
Varenicline (Chantix) and Counseling	7.76	± 0.57
Placebo Medicine and Counseling	8.98	± 0.55
3 Arms Combined	8.12	± 0.33

Medication Adherence Secondary · 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

Patch

Group	Value	95% CI
Combination NRT and Counseling	0.65	± 0.34
Placebo Medicine and Counseling	0.57	± 0.36

Lozenge

Group	Value	95% CI
Combination NRT and Counseling	0.57	± 0.39
Placebo Medicine and Counseling	0.57	± 0.38

Varenicline (Chantix)

Group	Value	95% CI
Varenicline (Chantix) and Counseling	0.67	± 0.32
Placebo Medicine and Counseling	0.70	± 0.35

Side Effects Secondary · 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.

Nausea

Group	Value	95% CI
Combination NRT and Counseling	53
Varenicline (Chantix) and Counseling	92
Placebo Medicine and Counseling	59

Vomiting

Group	Value	95% CI
Combination NRT and Counseling	28
Varenicline (Chantix) and Counseling	36
Placebo Medicine and Counseling	27

Racing Heart

Group	Value	95% CI
Combination NRT and Counseling	27
Varenicline (Chantix) and Counseling	24
Placebo Medicine and Counseling	17

Headache

Group	Value	95% CI
Combination NRT and Counseling	81
Varenicline (Chantix) and Counseling	81
Placebo Medicine and Counseling	71

Sleep Disturbance

Group	Value	95% CI
Combination NRT and Counseling	49
Varenicline (Chantix) and Counseling	55
Placebo Medicine and Counseling	42

Withdrawal Secondary · 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,

Anger

Group	Value	95% CI
Combination NRT and Counseling	1.33	± 0.75
Varenicline (Chantix) and Counseling	1.49	± 0.81
Placebo Medicine and Counseling	1.47	± .79

Anxiety

Group	Value	95% CI
Combination NRT and Counseling	1.69	± 0.79
Varenicline (Chantix) and Counseling	1.81	± 0.90
Placebo Medicine and Counseling	1.82	± 0.83

Concentration

Group	Value	95% CI
Combination NRT and Counseling	1.28	± 0.64
Varenicline (Chantix) and Counseling	1.48	± 0.76
Placebo Medicine and Counseling	1.42	± 0.76

Craving

Group	Value	95% CI
Combination NRT and Counseling	2.29	± 0.85
Varenicline (Chantix) and Counseling	2.20	± 0.86
Placebo Medicine and Counseling	2.50	± 0.83

Hunger

Group	Value	95% CI
Combination NRT and Counseling	2.11	± 0.84
Varenicline (Chantix) and Counseling	2.28	± 0.80
Placebo Medicine and Counseling	2.17	± 0.79

Sadness

Group	Value	95% CI
Combination NRT and Counseling	1.01	± 0.63
Varenicline (Chantix) and Counseling	1.11	± 0.69
Placebo Medicine and Counseling	1.11	± 0.61

Sleep

Group	Value	95% CI
Combination NRT and Counseling	1.49	± 0.82
Varenicline (Chantix) and Counseling	1.70	± 0.89
Placebo Medicine and Counseling	1.54	± 0.92

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Combination NRT and Counseling

Serious: 23/275 (8%)

Deaths: 3/275

Varenicline (Chantix) and Counseling

Serious: 17/274 (6%)

Deaths: 2/274

Placebo Medicine and Counseling

Serious: 27/273 (10%)

Deaths: 4/273

Serious adverse events (80 terms)

Reaction	System	Combination NRT and Counse…	Varenicline (Chantix) and …	Placebo Medicine and Couns…
COPD	Respiratory, thoracic and mediastinal disorders	—	—	—
Diverticulosis	Gastrointestinal disorders	—	—	—
Pneumonia	Respiratory, thoracic and mediastinal disorders	—	—	—
Hip replacement surgery	Surgical and medical procedures	—	—	—
Coronary artery disease	Cardiac disorders	—	—	—
Death due to cardiorespiratory arrest	Cardiac disorders	—	—	—
Death due to congestive heart failure	Cardiac disorders	—	—	—
Heart failure	Cardiac disorders	—	—	—
Left bundle branch block	Cardiac disorders	—	—	—
Death due to diabetic coma	Endocrine disorders	—	—	—
Diabetic ketoacidosis	Endocrine disorders	—	—	—
Hyperthyroidism	Endocrine disorders	—	—	—
Type 2 Diabetes	Endocrine disorders	—	—	—
Crohn's disease	Gastrointestinal disorders	—	—	—
Hemorrhoid	Gastrointestinal disorders	—	—	—
Pancreatitis	Gastrointestinal disorders	—	—	—
Death, unknown	General disorders	—	—	—
Death due to natural causes	General disorders	—	—	—
Ammonia poisoning of liver	Hepatobiliary disorders	—	—	—
Antibiotic spacer for MRSA infection in knee	Infections and infestations	—	—	—
Cellulitis, right hand	Infections and infestations	—	—	—
Ear infection	Infections and infestations	—	—	—
Surgical incision site infection (post-surgery)	Infections and infestations	—	—	—
Infection of second toe on left foot	Infections and infestations	—	—	—
Influenza	Infections and infestations	—	—	—

Other adverse events (23 terms — click to expand)

Reaction	System	Combination NRT and Counse…	Varenicline (Chantix) and …	Placebo Medicine and Couns…
Vivid dreams	Psychiatric disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Headache	Nervous system disorders	—	—	—
Feeling worried, nervous, scared, or anxious	Psychiatric disorders	—	—	—
Feeling significantly down, depressed, or hopeless	Psychiatric disorders	—	—	—
Feeling agitated and restless	Psychiatric disorders	—	—	—
Insomnia	Psychiatric disorders	—	—	—
Dizziness	Nervous system disorders	—	—	—
Indigestion	Gastrointestinal disorders	—	—	—
Sweating	Skin and subcutaneous tissue disorders	—	—	—
Hiccups	Respiratory, thoracic and mediastinal disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Itching/hives	Skin and subcutaneous tissue disorders	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—
Weakness	General disorders	—	—	—
Feeling hostile or angry towards others	Psychiatric disorders	—	—	—
Rapid, slow, pounding, or irregular heartbeat	Cardiac disorders	—	—	—
Chest tightness	Cardiac disorders	—	—	—
Feeling panicky or having panic attacks	Psychiatric disorders	—	—	—
Trouble breathing	Respiratory, thoracic and mediastinal disorders	—	—	—
Mouth problems (e.g. pain or sore)	Gastrointestinal disorders	—	—	—
Swelling or tingling in mouth or throat	Immune system disorders	—	—	—
Swelling in face or hands	Immune system disorders	—	—	—

Most-reported serious reactions: COPD, Diverticulosis, Pneumonia, Hip replacement surgery, Coronary artery disease, Death due to cardiorespiratory arrest, Death due to congestive heart failure, Heart failure.

Data from ClinicalTrials.gov NCT02351167 adverse events section.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Nicotine receptor partial agonists for smoking cessation.
Cahill K, Lindson-Hawley N, Thomas KH, Fanshawe TR, et al · · 2016 · cited 228× · PMID 27158893 · DOI 10.1002/14651858.cd006103.pub7
Genetic Variant in CHRNA5 and Response to Varenicline and Combination Nicotine Replacement in a Randomized Placebo-Controlled Trial.
Chen LS, Baker TB, Miller JP, Bray M, et al · · 2020 · cited 26× · PMID 32602170 · DOI 10.1002/cpt.1971
Biomedical risk assessment as an aid for smoking cessation.
Clair C, Mueller Y, Livingstone-Banks J, Burnand B, et al · · 2019 · cited 20× · PMID 30912847 · DOI 10.1002/14651858.cd004705.pub5
Most Current Smokers Desire Genetic Susceptibility Testing and Genetically-Efficacious Medication.
Chiu A, Hartz S, Smock N, Chen J, et al · · 2018 · cited 13× · PMID 30370503 · DOI 10.1007/s11481-018-9818-1
Racial disparities in intensity of smoke exposure and nicotine intake among low-dependence smokers.
Ho JTK, Tyndale RF, Baker TB, Amos CI, et al · · 2021 · cited 5× · PMID 33652379 · DOI 10.1016/j.drugalcdep.2021.108641

Verify or expand the search:

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Other Washington University School of Medicine trials

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02351167 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Washington University School of Medicine
Last refreshed: 22 September 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02351167.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing