Phase 4
Completed N=822
Genetically Informed Smoking Cessation Trial
Source: ClinicalTrials.gov NCT02351167 ↗Enrolled (actual)
822
Serious AEs
8.2%
Results posted
Mar 2020
Primary outcomePrimary: 7-day Point Prevalence Quit Rate — 55; 70; 24 Participants
◆ Published Evidence
Established
36citations · ~6 / year
Genetic Variant in CHRNA5 and Response to Varenicline and Combination Nicotine Replacement in a Randomized Placebo-Controlled 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.
Linked Publications
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Genetic Variant in CHRNA5 and Response to Varenicline and Combination Nicotine Replacement in a Randomized Placebo-Controlled Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 7-day Point Prevalence Quit Rate |
37; 56; 25 | — |
| SECONDARY Continuous Abstinence |
43; 46; 21 | — |
| SECONDARY 7-day Point Prevalence Quit Rate |
37; 56; 25 | — |
| SECONDARY Number of Days to Lapse |
16.78; 20.47; 11.85; 16.33 | — |
| SECONDARY Number of Days to Relapse |
44.83; 45.01; 28.87; 39.22 | — |
| SECONDARY Initial Cessation |
217; 186; 172 | — |
| SECONDARY Longitudinal Models of Abstinence Outcomes Across Multiple Time Points |
5; 3; 0; 8; 91; 94 | — |
| SECONDARY Longitudinal Models of Smoking Quantity in Cigarettes Per Day Outcomes Across Multiple Time Points. |
2.50; 2.95; 3.74; 3.06; 3.06; 3.18 | — |
| SECONDARY Medication Adherence |
0.65; 0.57; 0.57; 0.57; 0.67; 0.70 | — |
| SECONDARY Side Effects |
53; 92; 59; 28; 36; 27 | — |
| SECONDARY Withdrawal |
1.33; 1.49; 1.47; 1.69; 1.81; 1.82 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02351167) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.