Trial Outcomes & Findings for Improving Medication Compliance and Smoking Cessation Treatment Outcomes for African American Smokers (NCT NCT00781599)
NCT ID: NCT00781599
Last Updated: 2012-07-11
Results Overview
Compliance with Chantix calculated as the total doses taken over the total number of doses prescribed. Adherence was measured by pill counts. Measurements taken during monthly medication refill visits. There was no specific predetermined cutoff number on the scale which determined non-compliance. All results from compliance calculations are included in the table.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
72 participants
Primary outcome timeframe
Months 1, 2, 3
Results posted on
2012-07-11
Participant Flow
Participants were randomized between March and August 2009. Participants were recruited from Swope Health Central.
Participant milestones
| Measure |
Chantix for 3 Months, Standard Counseling
Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit.
|
Chantix for 3 Months and Adherence Counseling
Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit. Participants received 5 additional counseling sessions. Adherence counseling based on the Information-Motivation-Behavioral Skills model.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
36
|
|
Overall Study
COMPLETED
|
29
|
32
|
|
Overall Study
NOT COMPLETED
|
7
|
4
|
Reasons for withdrawal
| Measure |
Chantix for 3 Months, Standard Counseling
Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit.
|
Chantix for 3 Months and Adherence Counseling
Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit. Participants received 5 additional counseling sessions. Adherence counseling based on the Information-Motivation-Behavioral Skills model.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
4
|
Baseline Characteristics
Improving Medication Compliance and Smoking Cessation Treatment Outcomes for African American Smokers
Baseline characteristics by cohort
| Measure |
Chantix for 3 Months, Standard Counseling
n=36 Participants
Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit.
|
Chantix for 3 Months and Adherence Counseling
n=36 Participants
Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit. Participants received 5 additional counseling sessions. Adherence counseling based on the Information-Motivation-Behavioral Skills model.
|
Total
n=72 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
|
36 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age Continuous
|
44.3786 years
STANDARD_DEVIATION 11.046 • n=5 Participants
|
49.1980 years
STANDARD_DEVIATION 11.222 • n=7 Participants
|
46.788 years
STANDARD_DEVIATION 11.320 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=5 Participants
|
36 participants
n=7 Participants
|
72 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Months 1, 2, 3Population: Number of participants determined by total number of enrolled participants. For reporting purposes, those participants that did not show up for a visit were treated as smokers.
Compliance with Chantix calculated as the total doses taken over the total number of doses prescribed. Adherence was measured by pill counts. Measurements taken during monthly medication refill visits. There was no specific predetermined cutoff number on the scale which determined non-compliance. All results from compliance calculations are included in the table.
Outcome measures
| Measure |
Chantix for 3 Months, Standard Counseling
n=36 Participants
Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit.
|
Chantix for 3 Months and Adherence Counseling
n=36 Participants
Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit. Participants received 5 additional counseling sessions. Adherence counseling based on the Information-Motivation-Behavioral Skills model.
|
|---|---|---|
|
Percent Compliance With Chantix
Month 1
|
90.7 Percentage of Participants
Standard Deviation 9.5
|
85.8 Percentage of Participants
Standard Deviation 23.0
|
|
Percent Compliance With Chantix
Month 2
|
87.1 Percentage of Participants
Standard Deviation 18.9
|
91.7 Percentage of Participants
Standard Deviation 17.4
|
|
Percent Compliance With Chantix
Month 3
|
89.2 Percentage of Participants
Standard Deviation 24.4
|
82.1 Percentage of Participants
Standard Deviation 36.4
|
SECONDARY outcome
Timeframe: Month 3Population: A total of 61 participants completed the final month 3 visit. The 11 participants lost to follow-up were treated as smokers for the purposes of data analysis.
Smoking cessation verified by salivary cotinine (COT). A COT of \<20 ng/ml indicated smoking abstinence.
Outcome measures
| Measure |
Chantix for 3 Months, Standard Counseling
n=36 Participants
Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit.
|
Chantix for 3 Months and Adherence Counseling
n=36 Participants
Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit. Participants received 5 additional counseling sessions. Adherence counseling based on the Information-Motivation-Behavioral Skills model.
|
|---|---|---|
|
Cotinine Verified 7 Day Point Prevalence Smoking Abstinence
|
9 participants
.422
|
8 participants
.439
|
SECONDARY outcome
Timeframe: Month 1Population: A total of 60 participants completed the month 1 visit. The 12 participants lost to follow-up were treated as smokers for the purposes of data analysis.
Carbon monoxide-verified abstinence determined as a measure of \<10 ppm (parts per million). Less than 2ppm CO found in healthy non-smokers.
Outcome measures
| Measure |
Chantix for 3 Months, Standard Counseling
n=36 Participants
Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit.
|
Chantix for 3 Months and Adherence Counseling
n=36 Participants
Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit. Participants received 5 additional counseling sessions. Adherence counseling based on the Information-Motivation-Behavioral Skills model.
|
|---|---|---|
|
Carbon Monoxide-verified Abstinence
|
7 participants
.441
|
6 participants
.397
|
SECONDARY outcome
Timeframe: Month 2Population: A total of 57 participants completed the month 2 visit. The 15 participants lost to follow-up were treated as smokers for the purposes of data analysis.
Carbon monoxide-verified abstinence determined as a measure of \<10 ppm (parts per million). Less than 2ppm CO found in healthy non-smokers.
Outcome measures
| Measure |
Chantix for 3 Months, Standard Counseling
n=36 Participants
Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit.
|
Chantix for 3 Months and Adherence Counseling
n=36 Participants
Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit. Participants received 5 additional counseling sessions. Adherence counseling based on the Information-Motivation-Behavioral Skills model.
|
|---|---|---|
|
Carbon Monoxide-verified Abstinence
|
6 participants
16.981
|
5 participants
18.931
|
Adverse Events
Chantix for 3 Months, Standard Counseling
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Chantix for 3 Months and Adherence Counseling
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Chantix for 3 Months, Standard Counseling
n=36 participants at risk
Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit.
|
Chantix for 3 Months and Adherence Counseling
n=36 participants at risk
Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit. Participants received 5 additional counseling sessions. Adherence counseling based on the Information-Motivation-Behavioral Skills model.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
25.0%
9/36
|
25.0%
9/36
|
|
Gastrointestinal disorders
Gas
|
33.3%
12/36
|
33.3%
12/36
|
|
Gastrointestinal disorders
Dry Mouth
|
19.4%
7/36
|
33.3%
12/36
|
|
General disorders
Headaches
|
19.4%
7/36
|
36.1%
13/36
|
|
General disorders
constipation
|
11.1%
4/36
|
22.2%
8/36
|
|
General disorders
Trouble sleeping
|
25.0%
9/36
|
38.9%
14/36
|
|
General disorders
Irritability
|
16.7%
6/36
|
36.1%
13/36
|
|
General disorders
Dizziness
|
11.1%
4/36
|
16.7%
6/36
|
|
General disorders
Fatigue
|
27.8%
10/36
|
25.0%
9/36
|
|
General disorders
Abnormal Dreams
|
16.7%
6/36
|
19.4%
7/36
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place