Trial Outcomes & Findings for Varenicline for Light Smokers (NCT NCT01639560)

NCT ID: NCT01639560

Last Updated: 2018-02-22

Results Overview

To determine the efficacy of 12 weeks of varenicline therapy in achieving increased smoking abstinence rates in light smokers. Point prevalence is defined as no smoking in the past 7 days.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 93 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2018-02-22

Participant Flow

Participant milestones

Measure	Varenicline 1 mg of varenicline twice per day for 12 weeks. Varenicline: 1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling	Placebo 1 placebo tablet twice a day for 12 weeks Placebo: 1 placebo tablet twice per day for 12 weeks and brief behavioral counseling
Overall Study STARTED	45	48
Overall Study End of Treatment	28	20
Overall Study COMPLETED	26	19
Overall Study NOT COMPLETED	19	29

Reasons for withdrawal

Measure	Varenicline 1 mg of varenicline twice per day for 12 weeks. Varenicline: 1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling	Placebo 1 placebo tablet twice a day for 12 weeks Placebo: 1 placebo tablet twice per day for 12 weeks and brief behavioral counseling
Overall Study Withdrawal by Subject	9	14
Overall Study Lack of Efficacy	1	2
Overall Study Lost to Follow-up	9	11
Overall Study Adverse Event	0	2

Baseline Characteristics

Varenicline for Light Smokers

Baseline characteristics by cohort

Measure	Varenicline n=45 Participants 1 mg of varenicline twice per day for 12 weeks. Varenicline: 1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling	Placebo n=48 Participants 1 placebo tablet twice a day for 12 weeks Placebo: 1 placebo tablet twice per day for 12 weeks and brief behavioral counseling	Total n=93 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	45 Participants n=5 Participants	47 Participants n=7 Participants	92 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	37.1 years STANDARD_DEVIATION 11.7 • n=5 Participants	37.2 years STANDARD_DEVIATION 11.3 • n=7 Participants	37.2 years STANDARD_DEVIATION 11.4 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	34 Participants n=7 Participants	56 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	14 Participants n=7 Participants	37 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	45 Participants n=5 Participants	45 Participants n=7 Participants	90 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	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	36 Participants n=5 Participants	48 Participants n=7 Participants	84 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	0 Participants n=7 Participants	2 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	45 participants n=5 Participants	48 participants n=7 Participants	93 participants n=5 Participants
Baseline smoking rate (cigarettes per day)	7.9 cigarettes per day STANDARD_DEVIATION 1.5 • n=5 Participants	7.5 cigarettes per day STANDARD_DEVIATION 1.5 • n=7 Participants	7.7 cigarettes per day STANDARD_DEVIATION 1.5 • n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

To determine the efficacy of 12 weeks of varenicline therapy in achieving increased smoking abstinence rates in light smokers. Point prevalence is defined as no smoking in the past 7 days.

Outcome measures

Measure	Varenicline n=45 Participants 1 mg of varenicline twice per day for 12 weeks. Varenicline: 1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling	Placebo n=48 Participants 1 placebo tablet twice a day for 12 weeks Placebo: 1 placebo tablet twice per day for 12 weeks and brief behavioral counseling
Point Prevalence Smoking Outcome at 12 Weeks (End of Treatment)	24 participants	7 participants

PRIMARY outcome

Timeframe: 12 weeks

To determine the efficacy of 12 weeks of varenicline therapy in achieving increased smoking abstinence rates in light smokers. Prolonged abstinence is defined as no smoking since 2 weeks after the target quit date.

Outcome measures

Measure	Varenicline n=45 Participants 1 mg of varenicline twice per day for 12 weeks. Varenicline: 1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling	Placebo n=48 Participants 1 placebo tablet twice a day for 12 weeks Placebo: 1 placebo tablet twice per day for 12 weeks and brief behavioral counseling
Prolonged Smoking Outcome at 12 Weeks (End of Treatment)	18 participants	4 participants

SECONDARY outcome

Timeframe: 24 weeks

To determine the efficacy of 12 weeks of varenicline therapy in achieving increased smoking abstinence rates at 6 months in light smokers. Point prevalence is defined as no smoking in the past 7 days.

Outcome measures

Measure	Varenicline n=45 Participants 1 mg of varenicline twice per day for 12 weeks. Varenicline: 1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling	Placebo n=48 Participants 1 placebo tablet twice a day for 12 weeks Placebo: 1 placebo tablet twice per day for 12 weeks and brief behavioral counseling
Point Prevalence Smoking Outcome at 24 Weeks (End of Study)	18 participants	10 participants

SECONDARY outcome

Timeframe: 24 weeks

To determine the efficacy of 12 weeks of varenicline therapy in achieving increased smoking abstinence rates at 6 months in light smokers. Prolonged abstinence is defined as no smoking since 2 weeks after the target quit date.

Outcome measures

Measure	Varenicline n=45 Participants 1 mg of varenicline twice per day for 12 weeks. Varenicline: 1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling	Placebo n=48 Participants 1 placebo tablet twice a day for 12 weeks Placebo: 1 placebo tablet twice per day for 12 weeks and brief behavioral counseling
Prolonged Smoking Outcome at 24 Weeks (End of Study)	14 participants	4 participants

Adverse Events

Varenicline

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Varenicline n=45 participants at risk 1 mg of varenicline twice per day for 12 weeks. Varenicline: 1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling	Placebo n=48 participants at risk 1 placebo tablet twice a day for 12 weeks Placebo: 1 placebo tablet twice per day for 12 weeks and brief behavioral counseling
Gastrointestinal disorders Nausea	22.2% 10/45 • Number of events 10 • Serious Adverse Events were collected for the entire 6 months of study. Non-serious adverse events were collected for the 3 month-treatment phase.	0.00% 0/48 • Serious Adverse Events were collected for the entire 6 months of study. Non-serious adverse events were collected for the 3 month-treatment phase.
General disorders sleep disturbance	15.6% 7/45 • Number of events 7 • Serious Adverse Events were collected for the entire 6 months of study. Non-serious adverse events were collected for the 3 month-treatment phase.	2.1% 1/48 • Number of events 1 • Serious Adverse Events were collected for the entire 6 months of study. Non-serious adverse events were collected for the 3 month-treatment phase.
Psychiatric disorders Mood Disturbance	4.4% 2/45 • Number of events 2 • Serious Adverse Events were collected for the entire 6 months of study. Non-serious adverse events were collected for the 3 month-treatment phase.	2.1% 1/48 • Number of events 1 • Serious Adverse Events were collected for the entire 6 months of study. Non-serious adverse events were collected for the 3 month-treatment phase.
Psychiatric disorders Anxiety	2.2% 1/45 • Number of events 1 • Serious Adverse Events were collected for the entire 6 months of study. Non-serious adverse events were collected for the 3 month-treatment phase.	2.1% 1/48 • Number of events 1 • Serious Adverse Events were collected for the entire 6 months of study. Non-serious adverse events were collected for the 3 month-treatment phase.
Nervous system disorders Dizziness	4.4% 2/45 • Number of events 2 • Serious Adverse Events were collected for the entire 6 months of study. Non-serious adverse events were collected for the 3 month-treatment phase.	0.00% 0/48 • Serious Adverse Events were collected for the entire 6 months of study. Non-serious adverse events were collected for the 3 month-treatment phase.
Gastrointestinal disorders Gastro-esophageal reflux	4.4% 2/45 • Number of events 2 • Serious Adverse Events were collected for the entire 6 months of study. Non-serious adverse events were collected for the 3 month-treatment phase.	0.00% 0/48 • Serious Adverse Events were collected for the entire 6 months of study. Non-serious adverse events were collected for the 3 month-treatment phase.
Gastrointestinal disorders Diarrhea	2.2% 1/45 • Number of events 1 • Serious Adverse Events were collected for the entire 6 months of study. Non-serious adverse events were collected for the 3 month-treatment phase.	0.00% 0/48 • Serious Adverse Events were collected for the entire 6 months of study. Non-serious adverse events were collected for the 3 month-treatment phase.
General disorders Dry Mouth	2.2% 1/45 • Number of events 1 • Serious Adverse Events were collected for the entire 6 months of study. Non-serious adverse events were collected for the 3 month-treatment phase.	0.00% 0/48 • Serious Adverse Events were collected for the entire 6 months of study. Non-serious adverse events were collected for the 3 month-treatment phase.
Nervous system disorders headache	0.00% 0/45 • Serious Adverse Events were collected for the entire 6 months of study. Non-serious adverse events were collected for the 3 month-treatment phase.	2.1% 1/48 • Number of events 1 • Serious Adverse Events were collected for the entire 6 months of study. Non-serious adverse events were collected for the 3 month-treatment phase.
General disorders Loss of appetite	2.2% 1/45 • Number of events 1 • Serious Adverse Events were collected for the entire 6 months of study. Non-serious adverse events were collected for the 3 month-treatment phase.	0.00% 0/48 • Serious Adverse Events were collected for the entire 6 months of study. Non-serious adverse events were collected for the 3 month-treatment phase.
General disorders Taste Disturbance	2.2% 1/45 • Number of events 1 • Serious Adverse Events were collected for the entire 6 months of study. Non-serious adverse events were collected for the 3 month-treatment phase.	0.00% 0/48 • Serious Adverse Events were collected for the entire 6 months of study. Non-serious adverse events were collected for the 3 month-treatment phase.

Additional Information

Jon O. Ebbert, MD

Mayo Clinic

Phone: 507-266-1944

Email: nicotineresearch@mayo.edu

Results disclosure agreements

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