Smokers
Conditions
Keywords
African american, smokers, smoking cessation, African American smokers
Brief summary
Little is known about the support needed to improve compliance with Chantix for smoking cessation. This is a two arm pilot study of African American smokers to provide varying levels of side effect management and compliance support during a 12 week treatment period. The primary aim of the study is to estimate the effect of induction support compared to standard care in increasing compliance with Chantix at month 3
Interventions
DRUGChantix
Chantix 0.5 mg once daily on days 1-3, 0.5 mg twice daily on days 4-7, and 1 mg twice daily on day 8 through end of treatment at month 3
BEHAVIORALAdherence Counseling
Induction Support counseling on days 8, 12, 20 and months 1 and 2. Adherence counseling based on the Information-Motivation-Behavioral Skills model of adherence behavioral change.
BEHAVIORALStandard Counseling
Visit with counselor on Day 8 to develop a plan to quit smoking. Discuss strategies to quit, risks of continued smoking and discuss strategies for coping with withdrawal and craving.
Sponsors
Nikki Nollen, PhD, MA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* African American * 18-75 years of age * Smoke more than 10 cigarettes per day * Have a functioning telephone number * Be interested in quitting smoking * Be willing to take 3 months of Chantix * Be willing to complete all study visits
Exclusion criteria
* Renal impairment * Evidence or history of clinically significant allergic reactions to Chantix * Cardiovascular event in the past month * History of alcohol or drug abuse/dependency in the past year * Major depressive disorder in the last year requiring treatment * History of panic disorder * Psychosis, bipolar or eating disorder * Use of antidepressants, antipsychotics, mood stabilizers/anticonvulsants or naltrexone * Use of tobacco products other than cigarettes * Use of nicotine replacement therapy, bupropion, clonidine or nortriptyline in the month prior to enrollment * Prior use of Chantix * Women who are pregnant, contemplating getting pregnant or breastfeeding * Plans to move from Kansas City during the 3 month treatment phase * Another household member enrolled in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Compliance With Chantix | Months 1, 2, 3 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cotinine Verified 7 Day Point Prevalence Smoking Abstinence | Month 3 | Smoking cessation verified by salivary cotinine (COT). A COT of \<20 ng/ml indicated smoking abstinence. |
| Carbon Monoxide-verified Abstinence | Month 1 | Carbon monoxide-verified abstinence determined as a measure of \<10 ppm (parts per million). Less than 2ppm CO found in healthy non-smokers. |
Countries
United States
Participant flow
Recruitment details
Participants were randomized between March and August 2009. Participants were recruited from Swope Health Central.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 36 |
| 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. | 36 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 7 | 4 |
Baseline characteristics
| Characteristic | Chantix for 3 Months and Adherence Counseling | Chantix for 3 Months, Standard Counseling | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 0 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants | 36 Participants | 70 Participants |
| Age Continuous | 49.1980 years STANDARD_DEVIATION 11.222 | 44.3786 years STANDARD_DEVIATION 11.046 | 46.788 years STANDARD_DEVIATION 11.32 |
| Region of Enrollment United States | 36 participants | 36 participants | 72 participants |
| Sex: Female, Male Female | 12 Participants | 21 Participants | 33 Participants |
| Sex: Female, Male Male | 24 Participants | 15 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 12 / 36 | 14 / 36 |
| serious Total, serious adverse events | 0 / 36 | 0 / 36 |
Outcome results
Primary
Percent Compliance With Chantix
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.
Time frame: Months 1, 2, 3
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chantix for 3 Months, Standard Counseling | Percent Compliance With Chantix | Month 1 | 90.7 Percentage of Participants | Standard Deviation 9.5 |
| Chantix for 3 Months, Standard Counseling | Percent Compliance With Chantix | Month 2 | 87.1 Percentage of Participants | Standard Deviation 18.9 |
| Chantix for 3 Months, Standard Counseling | Percent Compliance With Chantix | Month 3 | 89.2 Percentage of Participants | Standard Deviation 24.4 |
| Chantix for 3 Months and Adherence Counseling | Percent Compliance With Chantix | Month 3 | 82.1 Percentage of Participants | Standard Deviation 36.4 |
| Chantix for 3 Months and Adherence Counseling | Percent Compliance With Chantix | Month 1 | 85.8 Percentage of Participants | Standard Deviation 23 |
| Chantix for 3 Months and Adherence Counseling | Percent Compliance With Chantix | Month 2 | 91.7 Percentage of Participants | Standard Deviation 17.4 |
Secondary
Carbon Monoxide-verified Abstinence
Carbon monoxide-verified abstinence determined as a measure of \<10 ppm (parts per million). Less than 2ppm CO found in healthy non-smokers.
Time frame: Month 1
Population: 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.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Chantix for 3 Months, Standard Counseling | Carbon Monoxide-verified Abstinence | 7 participants | 0.441 |
| Chantix for 3 Months and Adherence Counseling | Carbon Monoxide-verified Abstinence | 6 participants | 0.397 |
Secondary
Carbon Monoxide-verified Abstinence
Carbon monoxide-verified abstinence determined as a measure of \<10 ppm (parts per million). Less than 2ppm CO found in healthy non-smokers.
Time frame: Month 2
Population: 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.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Chantix for 3 Months, Standard Counseling | Carbon Monoxide-verified Abstinence | 6 participants | 16.981 |
| Chantix for 3 Months and Adherence Counseling | Carbon Monoxide-verified Abstinence | 5 participants | 18.931 |
Secondary
Cotinine Verified 7 Day Point Prevalence Smoking Abstinence
Smoking cessation verified by salivary cotinine (COT). A COT of \<20 ng/ml indicated smoking abstinence.
Time frame: Month 3
Population: 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.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Chantix for 3 Months, Standard Counseling | Cotinine Verified 7 Day Point Prevalence Smoking Abstinence | 9 participants | 0.422 |
| Chantix for 3 Months and Adherence Counseling | Cotinine Verified 7 Day Point Prevalence Smoking Abstinence | 8 participants | 0.439 |