Improving Medication Compliance and Smoking Cessation Treatment Outcomes for African American Smokers
This study has been completed.
Sponsor:
Nikki Nollen, PhD, MA
Information provided by (Responsible Party):
Nikki Nollen, PhD, MA, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00781599
First received: October 27, 2008
Last updated: June 27, 2012
Last verified: June 2012
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Results First Received: April 19, 2012
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Condition: |
Smokers |
| Interventions: |
Drug: Chantix Behavioral: Adherence Counseling Behavioral: Standard Counseling |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| Participants were randomized between March and August 2009. Participants were recruited from Swope Health Central. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| 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. |
Participant Flow: Overall Study
| Chantix for 3 Months, Standard Counseling | Chantix for 3 Months and Adherence Counseling | |
|---|---|---|
| STARTED | 36 | 36 |
| COMPLETED | 29 | 32 |
| NOT COMPLETED | 7 | 4 |
| Lost to Follow-up | 7 | 4 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| 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. |
| Total | Total of all reporting groups |
Baseline Measures
| Chantix for 3 Months, Standard Counseling | Chantix for 3 Months and Adherence Counseling | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
36 | 36 | 72 |
|
Age
[units: participants] |
|||
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 36 | 34 | 70 |
| >=65 years | 0 | 2 | 2 |
|
Age
[units: years] Mean ± Standard Deviation |
44.3786 ± 11.046 | 49.1980 ± 11.222 | 46.788 ± 11.320 |
|
Gender
[units: participants] |
|||
| Female | 21 | 12 | 33 |
| Male | 15 | 24 | 39 |
|
Region of Enrollment
[units: participants] |
|||
| United States | 36 | 36 | 72 |
Outcome Measures
| 1. Primary: | Percent Compliance With Chantix [ Time Frame: Months 1, 2, 3 ] |
Hide Outcome Measure 1| Measure Type | Primary |
|---|---|
| Measure Title | Percent Compliance With Chantix |
| Measure Description | 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 |
| Safety Issue | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| 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. |
Reporting Groups
| Description | |
|---|---|
| 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. |
Measured Values
| Chantix for 3 Months, Standard Counseling | Chantix for 3 Months and Adherence Counseling | |
|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
36 | 36 |
|
Percent Compliance With Chantix
[units: Percentage of Participants] Mean ± Standard Deviation |
||
| Month 1 | 90.7 ± 9.5 | 85.8 ± 23.0 |
| Month 2 | 87.1 ± 18.9 | 91.7 ± 17.4 |
| Month 3 | 89.2 ± 24.4 | 82.1 ± 36.4 |
No statistical analysis provided for Percent Compliance With Chantix
| 2. Secondary: | Cotinine Verified 7 Day Point Prevalence Smoking Abstinence [ Time Frame: Month 3 ] |
| 3. Secondary: | Carbon Monoxide-verified Abstinence [ Time Frame: Month 1 ] |
| 4. Secondary: | Carbon Monoxide-verified Abstinence [ Time Frame: Month 2 ] |
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| All Principal Investigators ARE employed by the organization sponsoring the study. |
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
Results Point of Contact:
Name/Title: Dr. Nikki Nollen
Organization: University of Kansas Medical Center
phone: (913) 588-3784
e-mail: NNOLLEN@kumc.edu
Organization: University of Kansas Medical Center
phone: (913) 588-3784
e-mail: NNOLLEN@kumc.edu
No publications provided
| Responsible Party: | Nikki Nollen, PhD, MA, University of Kansas Medical Center Research Institute |
| ClinicalTrials.gov Identifier: | NCT00781599 History of Changes |
| Other Study ID Numbers: | 11500 |
| Study First Received: | October 27, 2008 |
| Results First Received: | April 19, 2012 |
| Last Updated: | June 27, 2012 |
| Health Authority: | United States: Institutional Review Board |