Trial Outcomes & Findings for Individualizing Pharmacotherapy for African American Smokers (NCT NCT03897439)
NCT ID: NCT03897439
Last Updated: 2023-04-03
Results Overview
Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Week 12 visit. This will evaluate the short-term efficacy of optimized pharmacotherapy for smoking cessation in African American smokers.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
392 participants
Primary outcome timeframe
Week 12
Results posted on
2023-04-03
Participant Flow
Participant milestones
| Measure |
Usual Care (UC)
196 African American smokers will receive 12 weeks of smoking cessation counseling and 18 weeks of nicotine patch.
Nicotine patch: Participants will receive the 24-hour 21mg nicotine patch for up to 18 weeks of treatment.
|
Optimized Care (OPT)
196 African American smokers will receive 12 weeks of smoking cessation counseling. They will receive the nicotine patch and up to two pharmacotherapy adaptations (VAR, BUP+NP) based on verified smoking status at Weeks 2 and 6 for a total of 18 weeks of pharmacotherapy.
Nicotine patch: Participants will receive the 24-hour 21mg nicotine patch for up to 18 weeks of treatment.
Varenicline Tartrate: VAR will be dispensed 0.5 mg once daily on Days 1-3, 0.5 mg twice daily on Days 4-7, and 1 mg twice daily from Day 8 through the end of treatment.
Bupropion: BUP will be dispensed 150 mg once daily on Days 0-3 and then 150 mg twice daily from Day 4 through optimization or the end of treatment.
|
|---|---|---|
|
Randomization (Week 0)
STARTED
|
196
|
196
|
|
Randomization (Week 0)
Started on Nicotine Patch
|
196
|
196
|
|
Randomization (Week 0)
COMPLETED
|
196
|
196
|
|
Randomization (Week 0)
NOT COMPLETED
|
0
|
0
|
|
Optimization Point 1 (Week 2)
STARTED
|
187
|
187
|
|
Optimization Point 1 (Week 2)
Stayed on Nicotine Patch
|
187
|
61
|
|
Optimization Point 1 (Week 2)
Adapted to VAR
|
0
|
126
|
|
Optimization Point 1 (Week 2)
COMPLETED
|
187
|
187
|
|
Optimization Point 1 (Week 2)
NOT COMPLETED
|
0
|
0
|
|
Optimization Point 2 (Week 6)
STARTED
|
178
|
173
|
|
Optimization Point 2 (Week 6)
Stayed on Nicotine Patch
|
178
|
52
|
|
Optimization Point 2 (Week 6)
Stayed on VAR
|
0
|
25
|
|
Optimization Point 2 (Week 6)
Adapted to Varenicline
|
0
|
9
|
|
Optimization Point 2 (Week 6)
Adapted to BUP + Nicotine Patch
|
0
|
87
|
|
Optimization Point 2 (Week 6)
COMPLETED
|
178
|
173
|
|
Optimization Point 2 (Week 6)
NOT COMPLETED
|
0
|
0
|
|
Primary Endpoint (Week 12)
STARTED
|
174
|
165
|
|
Primary Endpoint (Week 12)
COMPLETED
|
174
|
165
|
|
Primary Endpoint (Week 12)
NOT COMPLETED
|
0
|
0
|
|
End of Treatment (Week 18)
STARTED
|
170
|
163
|
|
End of Treatment (Week 18)
COMPLETED
|
170
|
163
|
|
End of Treatment (Week 18)
NOT COMPLETED
|
0
|
0
|
|
End of Study (Week 26)
STARTED
|
162
|
162
|
|
End of Study (Week 26)
COMPLETED
|
162
|
162
|
|
End of Study (Week 26)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Individualizing Pharmacotherapy for African American Smokers
Baseline characteristics by cohort
| Measure |
Usual Care
n=196 Participants
196 African American smokers will receive 12 weeks of smoking cessation counseling and 18 weeks of nicotine patch.
Nicotine patch: Participants will receive the 24-hour 21mg nicotine patch for up to 18 weeks of treatment.
|
Optimized Care
n=196 Participants
196 African American smokers will receive 12 weeks of smoking cessation counseling. They will receive the nicotine patch and up to two pharmacotherapy adaptations (VAR, BUP+NP) based on verified smoking status at Weeks 2 and 6 for a total of 18 weeks of pharmacotherapy.
Nicotine patch: Participants will receive the 24-hour 21mg nicotine patch for up to 18 weeks of treatment.
|
Total
n=392 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.0 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
52.3 years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
52.6 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
110 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
224 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
86 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
168 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
196 Participants
n=5 Participants
|
196 Participants
n=7 Participants
|
392 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
|
196 Participants
n=5 Participants
|
196 Participants
n=7 Participants
|
392 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
196 participants
n=5 Participants
|
196 participants
n=7 Participants
|
392 participants
n=5 Participants
|
|
Cohabitation Status; Married/Living with partner
|
62 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Employment Status; Not currently employed
|
107 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
231 Participants
n=5 Participants
|
|
Education Level; some college or technical school
|
86 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
187 Participants
n=5 Participants
|
|
Has Health Insurance
|
138 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
262 Participants
n=5 Participants
|
|
% with a Federal Poverty Level <=100%
|
87 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
186 Participants
n=5 Participants
|
|
Housing; Own a home
|
36 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Cigarettes per day in the past 7 days
|
13.3 cigarettes per day
STANDARD_DEVIATION 7.3 • n=5 Participants
|
12.2 cigarettes per day
STANDARD_DEVIATION 6.9 • n=7 Participants
|
12.8 cigarettes per day
STANDARD_DEVIATION 7.1 • n=5 Participants
|
|
Menthol smoker
|
172 Participants
n=5 Participants
|
173 Participants
n=7 Participants
|
345 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Intent to treat with missing treated as smokers
Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Week 12 visit. This will evaluate the short-term efficacy of optimized pharmacotherapy for smoking cessation in African American smokers.
Outcome measures
| Measure |
Usual Care (UC)
n=196 Participants
196 African American smokers will receive 12 weeks of smoking cessation counseling and 18 weeks of nicotine patch.
Nicotine patch: Participants will receive the 24-hour 21mg nicotine patch for up to 18 weeks of treatment.
|
Optimized Care (OPT)
n=196 Participants
196 African American smokers will receive 12 weeks of smoking cessation counseling. They will receive the nicotine patch and up to two pharmacotherapy adaptations (VAR, BUP+NP) based on verified smoking status at Weeks 2 and 6 for a total of 18 weeks of pharmacotherapy.
Nicotine patch: Participants will receive the 24-hour 21mg nicotine patch for up to 18 weeks of treatment.
Varenicline Tartrate: VAR will be dispensed 0.5 mg once daily on Days 1-3, 0.5 mg twice daily on Days 4-7, and 1 mg twice daily from Day 8 through the end of treatment.
Bupropion: BUP will be dispensed 150 mg once daily on Days 0-3 and then 150 mg twice daily from Day 4 through optimization or the end of treatment.
|
|---|---|---|
|
Number of Participants With Biochemically Verified Smoking Abstinence at Week 12
|
23 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: Week 18Population: Intent to treat with missing treated as smokers
Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Week 18 visit. This will evaluate the end-of-treatment efficacy of optimized pharmacotherapy for smoking cessation in African American smokers
Outcome measures
| Measure |
Usual Care (UC)
n=196 Participants
196 African American smokers will receive 12 weeks of smoking cessation counseling and 18 weeks of nicotine patch.
Nicotine patch: Participants will receive the 24-hour 21mg nicotine patch for up to 18 weeks of treatment.
|
Optimized Care (OPT)
n=196 Participants
196 African American smokers will receive 12 weeks of smoking cessation counseling. They will receive the nicotine patch and up to two pharmacotherapy adaptations (VAR, BUP+NP) based on verified smoking status at Weeks 2 and 6 for a total of 18 weeks of pharmacotherapy.
Nicotine patch: Participants will receive the 24-hour 21mg nicotine patch for up to 18 weeks of treatment.
Varenicline Tartrate: VAR will be dispensed 0.5 mg once daily on Days 1-3, 0.5 mg twice daily on Days 4-7, and 1 mg twice daily from Day 8 through the end of treatment.
Bupropion: BUP will be dispensed 150 mg once daily on Days 0-3 and then 150 mg twice daily from Day 4 through optimization or the end of treatment.
|
|---|---|---|
|
Number of Participants With Biochemically Verified Smoking Abstinence at Week 18
|
31 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: Week 26Population: Intent to treat with missing treated as smokers.
Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Week 26 visit. This will evaluate the long-term efficacy of optimized pharmacotherapy for smoking cessation in African American smokers
Outcome measures
| Measure |
Usual Care (UC)
n=196 Participants
196 African American smokers will receive 12 weeks of smoking cessation counseling and 18 weeks of nicotine patch.
Nicotine patch: Participants will receive the 24-hour 21mg nicotine patch for up to 18 weeks of treatment.
|
Optimized Care (OPT)
n=196 Participants
196 African American smokers will receive 12 weeks of smoking cessation counseling. They will receive the nicotine patch and up to two pharmacotherapy adaptations (VAR, BUP+NP) based on verified smoking status at Weeks 2 and 6 for a total of 18 weeks of pharmacotherapy.
Nicotine patch: Participants will receive the 24-hour 21mg nicotine patch for up to 18 weeks of treatment.
Varenicline Tartrate: VAR will be dispensed 0.5 mg once daily on Days 1-3, 0.5 mg twice daily on Days 4-7, and 1 mg twice daily from Day 8 through the end of treatment.
Bupropion: BUP will be dispensed 150 mg once daily on Days 0-3 and then 150 mg twice daily from Day 4 through optimization or the end of treatment.
|
|---|---|---|
|
Number of Participants With Biochemically Verified Smoking Abstinence at Week 26
|
26 Participants
|
24 Participants
|
Adverse Events
Usual Care (UC)
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Optimized Care (OPT)
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Usual Care (UC)
n=196 participants at risk
196 African American smokers will receive 12 weeks of smoking cessation counseling and 18 weeks of nicotine patch.
Nicotine patch: Participants will receive the 24-hour 21mg nicotine patch for up to 18 weeks of treatment.
|
Optimized Care (OPT)
n=196 participants at risk
196 African American smokers will receive 12 weeks of smoking cessation counseling. They will receive the nicotine patch and up to two pharmacotherapy adaptations (VAR, BUP+NP) based on verified smoking status at Weeks 2 and 6 for a total of 18 weeks of pharmacotherapy.
Nicotine patch: Participants will receive the 24-hour 21mg nicotine patch for up to 18 weeks of treatment.
Varenicline Tartrate: VAR will be dispensed 0.5 mg once daily on Days 1-3, 0.5 mg twice daily on Days 4-7, and 1 mg twice daily from Day 8 through the end of treatment.
Bupropion: BUP will be dispensed 150 mg once daily on Days 0-3 and then 150 mg twice daily from Day 4 through optimization or the end of treatment.
|
|---|---|---|
|
General disorders
Redness/swelling/rash on the skin
|
12.8%
25/196 • Adverse event data was collected through Week 18.
Adverse event data was collected at each follow-up timepoint with a series of global side effect questions and a prompt to report an adverse events. Events are reported by group, overall (OPT, UC) , and not per intervention within group (e.g., optimized care: NP, optimized care: VAR, optimized care: BUP + NP) because many participants in OPT received all interventions and it is not possible to separate the adverse events they experienced during each of the interventions they received.
|
9.7%
19/196 • Adverse event data was collected through Week 18.
Adverse event data was collected at each follow-up timepoint with a series of global side effect questions and a prompt to report an adverse events. Events are reported by group, overall (OPT, UC) , and not per intervention within group (e.g., optimized care: NP, optimized care: VAR, optimized care: BUP + NP) because many participants in OPT received all interventions and it is not possible to separate the adverse events they experienced during each of the interventions they received.
|
|
General disorders
Sleeping Problems
|
1.5%
3/196 • Adverse event data was collected through Week 18.
Adverse event data was collected at each follow-up timepoint with a series of global side effect questions and a prompt to report an adverse events. Events are reported by group, overall (OPT, UC) , and not per intervention within group (e.g., optimized care: NP, optimized care: VAR, optimized care: BUP + NP) because many participants in OPT received all interventions and it is not possible to separate the adverse events they experienced during each of the interventions they received.
|
7.1%
14/196 • Adverse event data was collected through Week 18.
Adverse event data was collected at each follow-up timepoint with a series of global side effect questions and a prompt to report an adverse events. Events are reported by group, overall (OPT, UC) , and not per intervention within group (e.g., optimized care: NP, optimized care: VAR, optimized care: BUP + NP) because many participants in OPT received all interventions and it is not possible to separate the adverse events they experienced during each of the interventions they received.
|
|
Gastrointestinal disorders
Nausea or Vomiting
|
2.6%
5/196 • Adverse event data was collected through Week 18.
Adverse event data was collected at each follow-up timepoint with a series of global side effect questions and a prompt to report an adverse events. Events are reported by group, overall (OPT, UC) , and not per intervention within group (e.g., optimized care: NP, optimized care: VAR, optimized care: BUP + NP) because many participants in OPT received all interventions and it is not possible to separate the adverse events they experienced during each of the interventions they received.
|
7.1%
14/196 • Adverse event data was collected through Week 18.
Adverse event data was collected at each follow-up timepoint with a series of global side effect questions and a prompt to report an adverse events. Events are reported by group, overall (OPT, UC) , and not per intervention within group (e.g., optimized care: NP, optimized care: VAR, optimized care: BUP + NP) because many participants in OPT received all interventions and it is not possible to separate the adverse events they experienced during each of the interventions they received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place