Trial Outcomes & Findings for Varenicline or Nicotine Patch in Promoting Smoking Cessation Among Current Smokers (NCT NCT01771627)

NCT ID: NCT01771627

Last Updated: 2020-09-28

Results Overview

The quit rate at 4 months will be compared between the 2 groups, using a logistic regression analysis with a 2-side 95% confidence interval.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 300 participants
• Primary outcome timeframe: 4 months
• Results posted on: 2020-09-28

Participant Flow

Participant milestones

Measure	Arm I (Varenicline) Patients undergo general smoking cessation counseling and receive varenicline PO QD on days 1-28. Courses repeat every 28 days for up to 12 weeks. varenicline: Given PO	Arm II (Nicotine Patch) Patients undergo general smoking cessation counseling and receive nicotine patch continuously for 12 weeks. nicotine patch
Overall Study STARTED	200	100
Overall Study COMPLETED	92	50
Overall Study NOT COMPLETED	108	50

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Varenicline or Nicotine Patch in Promoting Smoking Cessation Among Current Smokers

Baseline characteristics by cohort

Measure	Arm I (Varenicline) n=200 Participants Patients undergo general smoking cessation counseling and receive varenicline PO QD on days 1-28. Courses repeat every 28 days for up to 12 weeks. varenicline: Given PO	Arm II (Nicotine Patch) n=100 Participants Patients undergo general smoking cessation counseling and receive nicotine patch continuously for 12 weeks. nicotine patch	Total n=300 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	200 Participants n=5 Participants	100 Participants n=7 Participants	300 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	47.2 years STANDARD_DEVIATION 13.9 • n=5 Participants	46.1 years STANDARD_DEVIATION 13.8 • n=7 Participants	47 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	93 Participants n=5 Participants	47 Participants n=7 Participants	140 Participants n=5 Participants
Sex: Female, Male Male	107 Participants n=5 Participants	53 Participants n=7 Participants	160 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	21 Participants n=5 Participants	13 Participants n=7 Participants	34 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	179 Participants n=5 Participants	87 Participants n=7 Participants	266 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	46 Participants n=5 Participants	16 Participants n=7 Participants	62 Participants n=5 Participants
Race (NIH/OMB) White	154 Participants n=5 Participants	84 Participants n=7 Participants	238 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	200 participants n=5 Participants	100 participants n=7 Participants	300 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 months

Population: self reported abstinence

The quit rate at 4 months will be compared between the 2 groups, using a logistic regression analysis with a 2-side 95% confidence interval.

Outcome measures

Measure	Arm I (Varenicline) n=36 Participants Patients undergo general smoking cessation counseling and receive varenicline PO QD on days 1-28. Courses repeat every 28 days for up to 12 weeks. varenicline: Given PO	Arm II (Nicotine Patch) n=50 Participants Patients undergo general smoking cessation counseling and receive nicotine patch continuously for 12 weeks. nicotine patch
Quit Rate	13 Participants	23 Participants

Adverse Events

Arm I (Varenicline)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm II (Nicotine Patch)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ben Toll

MUSC

Phone: 843-792-9162

Email: toll@musc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place