Phase 4 Completed N=1,086 Randomized Single-blind Treatment

A Comparative Effectiveness & Long Term Health Study in Wisconsin Smokers

Smoking Cessation · Smoking · Nicotine Dependence

Source: ClinicalTrials.gov NCT01553084 ↗

Enrolled (actual)

1,086

Serious AEs

0.1%

Results posted

Apr 2019

Primary outcomePrimary: Biochemically-confirmed 7-Day Point-Prevalence Abstinence at 26 Weeks — 63; 124; 108 Participants — p=.3623

Summary

The overall purpose of this research is two-fold. First, the two smoking cessation medication treatments with the strongest evidence of effectiveness have never been directly compared. This research will determine how these two treatments compare in effectiveness in a head-to-head trial, and which types of smokers benefit most from each. Second, much of the data on smoking and health come from studies from many years ago. Today's smokers differ from earlier smokers in many ways that could influence the impact of smoking on health (e.g., weight, sex, diet, socio-economic status); the proposed work will determine how smoking cessation affects cardiovascular and pulmonary health in today's smokers.

Outcome Measures

Outcome	Result	p-value
PRIMARY Biochemically-confirmed 7-Day Point-Prevalence Abstinence at 26 Weeks	63; 124; 108	.3623
SECONDARY Number of Days to Relapse	29.3; 37.4; 31.7	.3613
SECONDARY Number of Participants With Initial Cessation in the First 7 Days Post-quit	176; 339; 289	.03 sig
SECONDARY The Effects of Quitting Smoking vs. Continued Smoking on Change in Carotid Intima-media Thickness (CIMT).	-0.0682; -0.0620	.3282

Eligibility Criteria

We are only recruiting by invitation only (to members of our past cohort). We will open up enrollment to the public in the Madison, WI and Milwaukee WI areas at the end of 2012.

Inclusion Criteria

a. To be eligible for the Comparative effectiveness trial, participants must:

smoke 5 or more cigarettes per day,
desire to quit smoking but not be currently engaged in cessation treatment,
be medically eligible to use either combination NRT or varenicline,
have reliable phone access,
if female, must not be pregnant and must be willing to use an acceptable birth control method.

Exclusion Criteria

There are no exclusion criteria for participating in the main health outcomes study, other than being unwilling to complete study assessments.
All smoking participants from new and original cohorts will be excluded from the cessation trial for the following reasons:
end-stage renal disease with hemodialysis;
prior suicide attempts within the last 5 years or current suicidal ideation;
diagnosis of and/or treatment for schizophrenia;
other psychotic disorders or bipolar disorder within the last 10 years;
current PHQ-9 score indicative of moderately severe depression;
severe untreated hypertension >200/100 mmHg;
currently taking Wellbutrin, Zyban or bupropion;
hospitalized for a stroke, heart attack, congestive heart failure or diabetes within the last year;
used pipe tobacco, cigars, snuff or chew more than twice in the past week.

It should be noted that if any incidental findings appear in any of the cardiology tests (e.g., ultrasound, tonometry, ECG, or exercise stress test; see forms in Supplemental Information section of application), the study cardiologist (Dr. Stein or his designee) will be assign the participant to the non-randomized treatment arm and they will be given the nicotine patch and the same counseling intervention as CET participants. They will not be included in the CET analyses. This will be done to properly address the cardiovascular risk warning from the FDA regarding varenicline (Chantix).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01553084). 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.