Trial Outcomes & Findings for Understanding Disparities in Quitting in African American and White Smokers (NCT NCT01836276)
NCT ID: NCT01836276
Last Updated: 2018-10-24
Results Overview
Defined as having no cigarettes for the previous 7 days at the Week 26 visit. The recommended cut-off of 15ng/ml for salivary cotinine will be used to differentiate smokers from non-smokers.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
449 participants
Primary outcome timeframe
Change from Baseline to Week 26
Results posted on
2018-10-24
Participant Flow
Participant milestones
| Measure |
African American Smokers
African Americans smokers received 12 weeks of Varenicline and 6 smoking cessation counseling sessions.
Varenicline: 1 mg of varenicline twice daily after titration to full strength in the first week following standard dosing guidelines
|
White Smokers
White smokers received 12 weeks of Varenicline and 6 smoking cessation counseling sessions.
Varenicline: 1 mg of varenicline twice daily after titration to full strength in the first week following standard dosing guidelines
|
|---|---|---|
|
Overall Study
STARTED
|
224
|
225
|
|
Overall Study
Week 4
|
198
|
186
|
|
Overall Study
Week 12
|
183
|
165
|
|
Overall Study
COMPLETED
|
196
|
174
|
|
Overall Study
NOT COMPLETED
|
28
|
51
|
Reasons for withdrawal
| Measure |
African American Smokers
African Americans smokers received 12 weeks of Varenicline and 6 smoking cessation counseling sessions.
Varenicline: 1 mg of varenicline twice daily after titration to full strength in the first week following standard dosing guidelines
|
White Smokers
White smokers received 12 weeks of Varenicline and 6 smoking cessation counseling sessions.
Varenicline: 1 mg of varenicline twice daily after titration to full strength in the first week following standard dosing guidelines
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
28
|
51
|
Baseline Characteristics
Understanding Disparities in Quitting in African American and White Smokers
Baseline characteristics by cohort
| Measure |
African American
n=224 Participants
12 weeks of varenicline and 6 counseling sessions.
|
White
n=225 Participants
12 weeks of varenicline and 6 counseling sessions.
|
Total
n=449 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.4 years
STANDARD_DEVIATION 12 • n=5 Participants
|
40.5 years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
41.4 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
112 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
224 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
112 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
225 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
|
224 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
224 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
225 Participants
n=7 Participants
|
225 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
|
|
Cohabitation Status
Living alone
|
142 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
257 Participants
n=5 Participants
|
|
Cohabitation Status
Living with a partner
|
82 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
192 Participants
n=5 Participants
|
|
Employment Status
Employed full-time
|
77 Participants
n=5 Participants
|
142 Participants
n=7 Participants
|
219 Participants
n=5 Participants
|
|
Employment Status
Employed part-time
|
41 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Employment Status
Not currently employed
|
75 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Employment Status
Retired
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Employment Status
Student/homemaker
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Education level
Less than high school (HS) graduate
|
30 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Education level
HS graduate or HS equivalent (GED)
|
64 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Education level
Some college or tech school
|
90 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
206 Participants
n=5 Participants
|
|
Education level
College graduate or higher
|
40 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Health insurance that pays for most medical care
No
|
107 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
209 Participants
n=5 Participants
|
|
Health insurance that pays for most medical care
Yes
|
117 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
240 Participants
n=5 Participants
|
|
Income
|
21,293 Dollars
STANDARD_DEVIATION 15,501 • n=5 Participants
|
35,806 Dollars
STANDARD_DEVIATION 21,035 • n=7 Participants
|
28,566 Dollars
STANDARD_DEVIATION 19,840 • n=5 Participants
|
|
Number of people living in house, including self
|
2.7 Cohabitants
STANDARD_DEVIATION 1.6 • n=5 Participants
|
3.0 Cohabitants
STANDARD_DEVIATION 1.8 • n=7 Participants
|
2.8 Cohabitants
STANDARD_DEVIATION 1.7 • n=5 Participants
|
|
Housing
Own a home
|
38 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Housing
Rent or stay with others
|
186 Participants
n=5 Participants
|
148 Participants
n=7 Participants
|
334 Participants
n=5 Participants
|
|
Perceived Health
Good, fair, or poor
|
125 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
238 Participants
n=5 Participants
|
|
Perceived Health
Very good/excellent
|
99 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
211 Participants
n=5 Participants
|
|
Percent Federal Poverty Level
< or = 100%
|
115 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
|
Percent Federal Poverty Level
101%-200%
|
72 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
|
Percent Federal Poverty Level
201%-250%
|
15 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Percent Federal Poverty Level
251%-300%
|
9 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Percent Federal Poverty Level
301%-400%
|
13 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Height in inches
|
66.8 inches
STANDARD_DEVIATION 3.7 • n=5 Participants
|
66.8 inches
STANDARD_DEVIATION 3.9 • n=7 Participants
|
66.8 inches
STANDARD_DEVIATION 3.8 • n=5 Participants
|
|
Weight in pounds
|
195.3 pounds
STANDARD_DEVIATION 51.2 • n=5 Participants
|
182.9 pounds
STANDARD_DEVIATION 44.1 • n=7 Participants
|
189.1 pounds
STANDARD_DEVIATION 48.1 • n=5 Participants
|
|
BMI
|
30.8 kg/m^2
STANDARD_DEVIATION 8.1 • n=5 Participants
|
28.9 kg/m^2
STANDARD_DEVIATION 7.1 • n=7 Participants
|
29.8 kg/m^2
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Waist circumference in inches
|
37.6 inches
STANDARD_DEVIATION 6.7 • n=5 Participants
|
36.3 inches
STANDARD_DEVIATION 6.2 • n=7 Participants
|
37.0 inches
STANDARD_DEVIATION 6.4 • n=5 Participants
|
|
Cigarettes per day
|
12.5 Cigarettes
STANDARD_DEVIATION 5.7 • n=5 Participants
|
16.9 Cigarettes
STANDARD_DEVIATION 4.6 • n=7 Participants
|
14.7 Cigarettes
STANDARD_DEVIATION 5.7 • n=5 Participants
|
|
Age when you started smoking regularly
|
18.5 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
16.5 years
STANDARD_DEVIATION 4.8 • n=7 Participants
|
17.5 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
|
Menthol smoker
Non-menthol
|
31 Participants
n=5 Participants
|
166 Participants
n=7 Participants
|
197 Participants
n=5 Participants
|
|
Menthol smoker
Menthol
|
193 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
252 Participants
n=5 Participants
|
|
Longest quit attempt in months
|
24.8 months
STANDARD_DEVIATION 70.9 • n=5 Participants
|
25.3 months
STANDARD_DEVIATION 51.7 • n=7 Participants
|
25.0 months
STANDARD_DEVIATION 62.0 • n=5 Participants
|
|
Time to first cigarette
After 30 minutes
|
47 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Time to first cigarette
Within 30 minutes
|
177 Participants
n=5 Participants
|
168 Participants
n=7 Participants
|
345 Participants
n=5 Participants
|
|
Number of your five best friends smoke
|
2.9 friends
STANDARD_DEVIATION 1.8 • n=5 Participants
|
2.7 friends
STANDARD_DEVIATION 1.7 • n=7 Participants
|
2.8 friends
STANDARD_DEVIATION 1.8 • n=5 Participants
|
|
Number of smokers in the home(not including self)
|
0.6 cohabitants
STANDARD_DEVIATION 1.0 • n=5 Participants
|
0.6 cohabitants
STANDARD_DEVIATION 0.8 • n=7 Participants
|
0.6 cohabitants
STANDARD_DEVIATION 0.9 • n=5 Participants
|
|
Partner smoking status
No partner/spouse
|
94 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
|
Partner smoking status
Partner/spouse is a non-smoker
|
68 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
|
Partner smoking status
Partner/spouse is a smoker
|
62 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
Withdrawal
|
5.3 units on a scale
STANDARD_DEVIATION 4.3 • n=5 Participants
|
5.2 units on a scale
STANDARD_DEVIATION 3.1 • n=7 Participants
|
5.3 units on a scale
STANDARD_DEVIATION 3.8 • n=5 Participants
|
|
Craving
|
14.1 units on a scale
STANDARD_DEVIATION 7.9 • n=5 Participants
|
15.3 units on a scale
STANDARD_DEVIATION 6.7 • n=7 Participants
|
14.7 units on a scale
STANDARD_DEVIATION 7.3 • n=5 Participants
|
|
Perceived stress
|
4.5 units on a scale
STANDARD_DEVIATION 2.7 • n=5 Participants
|
3.6 units on a scale
STANDARD_DEVIATION 2.3 • n=7 Participants
|
4.1 units on a scale
STANDARD_DEVIATION 2.6 • n=5 Participants
|
|
Depression
|
2.1 units on a scale
STANDARD_DEVIATION 3.4 • n=5 Participants
|
1.2 units on a scale
STANDARD_DEVIATION 1.8 • n=7 Participants
|
1.7 units on a scale
STANDARD_DEVIATION 2.7 • n=5 Participants
|
|
Anxiety
|
3.0 units on a scale
STANDARD_DEVIATION 3.6 • n=5 Participants
|
2.1 units on a scale
STANDARD_DEVIATION 2.7 • n=7 Participants
|
2.5 units on a scale
STANDARD_DEVIATION 3.2 • n=5 Participants
|
|
Financial strain
|
15.6 units on a scale
STANDARD_DEVIATION 4.3 • n=5 Participants
|
14.6 units on a scale
STANDARD_DEVIATION 4.1 • n=7 Participants
|
15.1 units on a scale
STANDARD_DEVIATION 4.2 • n=5 Participants
|
|
Perceived discrimination
number of situations encountered
|
2.7 units on a scale
STANDARD_DEVIATION 1.6 • n=5 Participants
|
2.6 units on a scale
STANDARD_DEVIATION 1.6 • n=7 Participants
|
2.7 units on a scale
STANDARD_DEVIATION 1.6 • n=5 Participants
|
|
Perceived discrimination
frequency encountered
|
6.8 units on a scale
STANDARD_DEVIATION 5.1 • n=5 Participants
|
5.1 units on a scale
STANDARD_DEVIATION 4.1 • n=7 Participants
|
5.9 units on a scale
STANDARD_DEVIATION 4.9 • n=5 Participants
|
|
Race Consciousness
Never
|
109 Participants
n=5 Participants
|
158 Participants
n=7 Participants
|
267 Participants
n=5 Participants
|
|
Race Consciousness
Once a year
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race Consciousness
Once a month
|
22 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race Consciousness
Once a week
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race Consciousness
At least daily
|
54 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Perceived social status
|
4.8 units on a scale
STANDARD_DEVIATION 1.5 • n=5 Participants
|
5.0 units on a scale
STANDARD_DEVIATION 1.5 • n=7 Participants
|
4.9 units on a scale
STANDARD_DEVIATION 1.5 • n=5 Participants
|
|
Satisfaction with life
|
20.1 units on a scale
STANDARD_DEVIATION 6.3 • n=5 Participants
|
23.8 units on a scale
STANDARD_DEVIATION 5.5 • n=7 Participants
|
22.0 units on a scale
STANDARD_DEVIATION 6.2 • n=5 Participants
|
|
Cynicism/distrust of others' intentions
|
5.7 units on a scale
STANDARD_DEVIATION 1.6 • n=5 Participants
|
4.8 units on a scale
STANDARD_DEVIATION 1.7 • n=7 Participants
|
5.3 units on a scale
STANDARD_DEVIATION 1.7 • n=5 Participants
|
|
Neuroticism/proneness to psychological stress
|
12.6 units on a scale
STANDARD_DEVIATION 7.1 • n=5 Participants
|
12.5 units on a scale
STANDARD_DEVIATION 6.3 • n=7 Participants
|
12.5 units on a scale
STANDARD_DEVIATION 6.7 • n=5 Participants
|
|
Social cohesion and trust
|
16.2 units on a scale
STANDARD_DEVIATION 4.7 • n=5 Participants
|
17.8 units on a scale
STANDARD_DEVIATION 4.5 • n=7 Participants
|
17.0 units on a scale
STANDARD_DEVIATION 4.7 • n=5 Participants
|
|
Neighborhood problems
|
15.5 units on a scale
STANDARD_DEVIATION 4.7 • n=5 Participants
|
13.5 units on a scale
STANDARD_DEVIATION 3.4 • n=7 Participants
|
14.5 units on a scale
STANDARD_DEVIATION 4.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline to Week 26Defined as having no cigarettes for the previous 7 days at the Week 26 visit. The recommended cut-off of 15ng/ml for salivary cotinine will be used to differentiate smokers from non-smokers.
Outcome measures
| Measure |
African American (AA) Smokers
n=224 Participants
AA smokers received 12 weeks of Varenicline and 6 smoking cessation counseling sessions.
Varenicline: 1 mg of varenicline twice daily after titration to full strength in the first week following standard dosing guidelines
|
White Smokers
n=225 Participants
White smokers received 12 weeks of Varenicline and 6 smoking cessation counseling sessions.
Varenicline: 1 mg of varenicline twice daily after titration to full strength in the first week following standard dosing guidelines
|
|---|---|---|
|
Number of Participants With Cotinine-verified 7-day Point Prevalence Smoking Abstinence at Week 26
|
32 Participants
|
55 Participants
|
Adverse Events
African American
Serious events: 1 serious events
Other events: 210 other events
Deaths: 0 deaths
White
Serious events: 5 serious events
Other events: 206 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
African American
n=224 participants at risk
Varenicline treatment began at Week 0 and continued through Week 12. Adverse events were monitored through week 16.
|
White
n=225 participants at risk
Varenicline treatment began at Week 0 and continued through Week 12. Adverse events were monitored through week 16.
|
|---|---|---|
|
Cardiac disorders
Fluid on the heart
|
0.45%
1/224 • Number of events 1 • Adverse events were collected between weeks 0-16.
|
0.00%
0/225 • Adverse events were collected between weeks 0-16.
|
|
Psychiatric disorders
Depressive episode
|
0.00%
0/224 • Adverse events were collected between weeks 0-16.
|
0.44%
1/225 • Number of events 1 • Adverse events were collected between weeks 0-16.
|
|
Vascular disorders
Seizure
|
0.00%
0/224 • Adverse events were collected between weeks 0-16.
|
0.44%
1/225 • Number of events 1 • Adverse events were collected between weeks 0-16.
|
|
Cardiac disorders
Heart attack
|
0.00%
0/224 • Adverse events were collected between weeks 0-16.
|
0.44%
1/225 • Number of events 1 • Adverse events were collected between weeks 0-16.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/224 • Adverse events were collected between weeks 0-16.
|
0.44%
1/225 • Number of events 1 • Adverse events were collected between weeks 0-16.
|
|
Gastrointestinal disorders
Intestinal blockage
|
0.00%
0/224 • Adverse events were collected between weeks 0-16.
|
0.44%
1/225 • Number of events 1 • Adverse events were collected between weeks 0-16.
|
Other adverse events
| Measure |
African American
n=224 participants at risk
Varenicline treatment began at Week 0 and continued through Week 12. Adverse events were monitored through week 16.
|
White
n=225 participants at risk
Varenicline treatment began at Week 0 and continued through Week 12. Adverse events were monitored through week 16.
|
|---|---|---|
|
Psychiatric disorders
Hostility, aggression, or other change in behavior not normal for you
|
5.9%
13/220 • Number of events 13 • Adverse events were collected between weeks 0-16.
|
6.1%
13/214 • Number of events 13 • Adverse events were collected between weeks 0-16.
|
|
General disorders
Fatigue or loss of energy
|
8.2%
18/220 • Number of events 18 • Adverse events were collected between weeks 0-16.
|
9.8%
21/214 • Number of events 21 • Adverse events were collected between weeks 0-16.
|
|
Gastrointestinal disorders
Nausea
|
15.5%
34/220 • Number of events 34 • Adverse events were collected between weeks 0-16.
|
20.1%
43/214 • Number of events 43 • Adverse events were collected between weeks 0-16.
|
|
General disorders
Trouble Sleeping
|
11.8%
26/220 • Number of events 26 • Adverse events were collected between weeks 0-16.
|
13.1%
28/214 • Number of events 28 • Adverse events were collected between weeks 0-16.
|
|
General disorders
Headaches
|
9.1%
20/220 • Number of events 20 • Adverse events were collected between weeks 0-16.
|
7.9%
17/214 • Number of events 17 • Adverse events were collected between weeks 0-16.
|
|
General disorders
Abnormal dreams
|
13.2%
29/220 • Number of events 29 • Adverse events were collected between weeks 0-16.
|
4.2%
9/214 • Number of events 9 • Adverse events were collected between weeks 0-16.
|
|
Gastrointestinal disorders
Gas or flatulence
|
16.8%
37/220 • Number of events 37 • Adverse events were collected between weeks 0-16.
|
15.0%
32/214 • Number of events 32 • Adverse events were collected between weeks 0-16.
|
|
Gastrointestinal disorders
Constipation
|
11.8%
26/220 • Number of events 26 • Adverse events were collected between weeks 0-16.
|
8.4%
18/214 • Number of events 18 • Adverse events were collected between weeks 0-16.
|
|
General disorders
Dizziness
|
3.6%
8/220 • Number of events 8 • Adverse events were collected between weeks 0-16.
|
1.4%
3/214 • Number of events 3 • Adverse events were collected between weeks 0-16.
|
|
General disorders
Dry mouth
|
8.2%
18/220 • Number of events 18 • Adverse events were collected between weeks 0-16.
|
7.9%
17/214 • Number of events 17 • Adverse events were collected between weeks 0-16.
|
|
Psychiatric disorders
Irritability
|
10.9%
24/220 • Number of events 24 • Adverse events were collected between weeks 0-16.
|
12.6%
27/214 • Number of events 27 • Adverse events were collected between weeks 0-16.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place