Trial Outcomes & Findings for Advancing Tobacco Use Treatment for African American Smokers (NCT NCT02360631)
NCT ID: NCT02360631
Last Updated: 2020-07-15
Results Overview
Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Month 6 visit
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
500 participants
Primary outcome timeframe
Month 6
Results posted on
2020-07-15
Participant Flow
Participant milestones
| Measure |
Chantix (Varenicline)
Participants will receive 1mg pills to take twice a day for 12 weeks.
Chantix: A drug used to treat nicotine addiction.Chantix is approved by the FDA to be given to help people quit smoking.
|
Placebo
Participants will receive a placebo pill to take twice a day for 12 weeks.
Placebo: Health education counseling will be provided to all participants.
|
|---|---|---|
|
Overall Study
STARTED
|
300
|
200
|
|
Overall Study
Week 12
|
249
|
165
|
|
Overall Study
COMPLETED
|
267
|
174
|
|
Overall Study
NOT COMPLETED
|
33
|
26
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Advancing Tobacco Use Treatment for African American Smokers
Baseline characteristics by cohort
| Measure |
Chantix (Varenicline)
n=300 Participants
Participants will receive 1mg pills to take twice a day for 12 weeks.
Chantix: A drug used to treat nicotine addiction.Chantix is approved by the FDA to be given to help people quit smoking.
|
Placebo
n=200 Participants
Participants will receive a placebo pill to take twice a day for 12 weeks.
Placebo: Health education counseling will be provided to all participants.
|
Total
n=500 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.6 years
STANDARD_DEVIATION 11.9 • n=99 Participants
|
52.4 years
STANDARD_DEVIATION 11.0 • n=107 Participants
|
51.9 years
STANDARD_DEVIATION 11.5 • n=206 Participants
|
|
Sex/Gender, Customized
Female
|
156 Participants
n=99 Participants
|
106 Participants
n=107 Participants
|
262 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Male
|
144 Participants
n=99 Participants
|
94 Participants
n=107 Participants
|
238 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African American
|
300 Participants
n=99 Participants
|
200 Participants
n=107 Participants
|
500 Participants
n=206 Participants
|
|
Employed
|
143 Participants
n=99 Participants
|
113 Participants
n=107 Participants
|
256 Participants
n=206 Participants
|
|
BMI
|
30.6 kg/m^2
STANDARD_DEVIATION 7.1 • n=99 Participants
|
30.1 kg/m^2
STANDARD_DEVIATION 7.6 • n=107 Participants
|
30.4 kg/m^2
STANDARD_DEVIATION 7.3 • n=206 Participants
|
|
Cigarettes per day
|
12.9 cigarettes per day
STANDARD_DEVIATION 6.9 • n=99 Participants
|
12.2 cigarettes per day
STANDARD_DEVIATION 6.2 • n=107 Participants
|
12.6 cigarettes per day
STANDARD_DEVIATION 6.6 • n=206 Participants
|
PRIMARY outcome
Timeframe: Month 6Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Month 6 visit
Outcome measures
| Measure |
Chantix (Varenicline)
n=300 Participants
Participants will receive 1mg pills to take twice a day for 12 weeks.
Chantix: A drug used to treat nicotine addiction.Chantix is approved by the FDA to be given to help people quit smoking.
|
Placebo
n=200 Participants
Participants will receive a placebo pill to take twice a day for 12 weeks.
Placebo: Health education counseling will be provided to all participants.
|
|---|---|---|
|
Number of Participants With Smoking Abstinence at Month 6
|
47 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Week 12Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Week 12 visit
Outcome measures
| Measure |
Chantix (Varenicline)
n=300 Participants
Participants will receive 1mg pills to take twice a day for 12 weeks.
Chantix: A drug used to treat nicotine addiction.Chantix is approved by the FDA to be given to help people quit smoking.
|
Placebo
n=200 Participants
Participants will receive a placebo pill to take twice a day for 12 weeks.
Placebo: Health education counseling will be provided to all participants.
|
|---|---|---|
|
Number of Participants With Smoking Abstinence at Week 12
|
56 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Week 26Population: 300 participants received varenicline and of those 154 were Light smokers (10 or less cigarettes per day (CPD) and 146 were moderate to heavy smokers (greater than 10 )CPD. 200 participants received placebo medication and of those 106 were light smokers and 94 were moderate to heavy smokers.
Intent to treat Cotinine verified cessation for light and moderate to heavy smokers by treatment
Outcome measures
| Measure |
Chantix (Varenicline)
n=300 Participants
Participants will receive 1mg pills to take twice a day for 12 weeks.
Chantix: A drug used to treat nicotine addiction.Chantix is approved by the FDA to be given to help people quit smoking.
|
Placebo
n=200 Participants
Participants will receive a placebo pill to take twice a day for 12 weeks.
Placebo: Health education counseling will be provided to all participants.
|
|---|---|---|
|
Number of Participants With Smoking Abstinence at Week 26
Light
|
33 Participants
|
9 Participants
|
|
Number of Participants With Smoking Abstinence at Week 26
Heavy
|
14 Participants
|
4 Participants
|
Adverse Events
Chantix (Varenicline)
Serious events: 0 serious events
Other events: 276 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 178 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Chantix (Varenicline)
n=300 participants at risk
Participants will receive 1mg pills to take twice a day for 12 weeks.
Chantix: A drug used to treat nicotine addiction.Chantix is approved by the FDA to be given to help people quit smoking.
|
Placebo
n=200 participants at risk
Participants will receive a placebo pill to take twice a day for 12 weeks.
Placebo: Health education counseling will be provided to all participants.
|
|---|---|---|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/300 • Adverse event data was systematically collected between weeks 0-16.
|
0.50%
1/200 • Number of events 1 • Adverse event data was systematically collected between weeks 0-16.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial inflammation
|
0.00%
0/300 • Adverse event data was systematically collected between weeks 0-16.
|
0.50%
1/200 • Number of events 1 • Adverse event data was systematically collected between weeks 0-16.
|
Other adverse events
| Measure |
Chantix (Varenicline)
n=300 participants at risk
Participants will receive 1mg pills to take twice a day for 12 weeks.
Chantix: A drug used to treat nicotine addiction.Chantix is approved by the FDA to be given to help people quit smoking.
|
Placebo
n=200 participants at risk
Participants will receive a placebo pill to take twice a day for 12 weeks.
Placebo: Health education counseling will be provided to all participants.
|
|---|---|---|
|
Psychiatric disorders
Change in hostility or aggression
|
33.0%
99/300 • Number of events 99 • Adverse event data was systematically collected between weeks 0-16.
|
39.5%
79/200 • Number of events 79 • Adverse event data was systematically collected between weeks 0-16.
|
|
General disorders
Fatigue or Loss of Energy
|
54.3%
163/300 • Number of events 163 • Adverse event data was systematically collected between weeks 0-16.
|
56.0%
112/200 • Number of events 112 • Adverse event data was systematically collected between weeks 0-16.
|
|
Gastrointestinal disorders
Nausea
|
54.3%
163/300 • Number of events 163 • Adverse event data was systematically collected between weeks 0-16.
|
45.0%
90/200 • Number of events 90 • Adverse event data was systematically collected between weeks 0-16.
|
|
General disorders
Trouble sleeping
|
63.3%
190/300 • Number of events 190 • Adverse event data was systematically collected between weeks 0-16.
|
58.5%
117/200 • Number of events 117 • Adverse event data was systematically collected between weeks 0-16.
|
|
General disorders
Headaches
|
52.3%
157/300 • Number of events 157 • Adverse event data was systematically collected between weeks 0-16.
|
47.5%
95/200 • Number of events 95 • Adverse event data was systematically collected between weeks 0-16.
|
|
General disorders
Abnormal dreams
|
48.7%
146/300 • Number of events 146 • Adverse event data was systematically collected between weeks 0-16.
|
46.5%
93/200 • Number of events 93 • Adverse event data was systematically collected between weeks 0-16.
|
|
Gastrointestinal disorders
Gas or flatulence
|
63.7%
191/300 • Number of events 191 • Adverse event data was systematically collected between weeks 0-16.
|
65.0%
130/200 • Number of events 130 • Adverse event data was systematically collected between weeks 0-16.
|
|
Gastrointestinal disorders
Constipation
|
40.0%
120/300 • Number of events 120 • Adverse event data was systematically collected between weeks 0-16.
|
39.0%
78/200 • Number of events 78 • Adverse event data was systematically collected between weeks 0-16.
|
|
General disorders
Dizziness
|
31.7%
95/300 • Number of events 95 • Adverse event data was systematically collected between weeks 0-16.
|
31.0%
62/200 • Number of events 62 • Adverse event data was systematically collected between weeks 0-16.
|
|
General disorders
Dry mouth
|
61.0%
183/300 • Number of events 183 • Adverse event data was systematically collected between weeks 0-16.
|
64.5%
129/200 • Number of events 129 • Adverse event data was systematically collected between weeks 0-16.
|
|
Psychiatric disorders
Irritability
|
55.7%
167/300 • Number of events 167 • Adverse event data was systematically collected between weeks 0-16.
|
55.5%
111/200 • Number of events 111 • Adverse event data was systematically collected between weeks 0-16.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place