SmokersNCT00781599
Improving Medication Compliance and Smoking Cessation Treatment Outcomes for African American Smokers
A study testing Chantix, Adherence Counseling and Standard Counseling in people with Smokers, run by Nikki Nollen, PhD, MA at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Smokers
- What is being tested?
- Chantix, Adherence Counseling and Standard Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Mar 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
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
- Conditions
- Smokers
- Being tested
- Chantix, Adherence Counseling, Standard Counseling
- Keywords
- African american, smokers, smoking cessation, African American smokers
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChantixDrug
Also called varenicline
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
Adherence CounselingBehavioural
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.
Standard CounselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Chantix for 3 months and Standard Counseling Receives: Drug: Chantix; Behavioral: Standard Counseling |
| 2 | Experimental | Chantix for 3 months and Adherence Counseling Receives: Drug: Chantix; Behavioral: Adherence Counseling; Behavioral: Standard Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Months 1, 2, 3
Secondary outcomes (3)
Cotinine Verified 7 Day Point Prevalence Smoking Abstinence
Smoking cessation verified by salivary cotinine (COT). A COT of <20 ng/ml indicated smoking abstinence.
Measured: Month 3
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.
Measured: Month 1
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.
Measured: Month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nikki Nollen, PhD, MA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nikki Nollen, PhD, MA, University of Kansas Medical Center
- Investigators
- Nicole Nollen, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00781599
- Sponsor's protocol ID
- 11500
- Status last verified
- Jun 2012
- First submitted
- 27 Oct 2008
- Last updated
- 11 Jul 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
PubMed 37142273
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Medication Compliance and Smoking Cessation Treatment Outcomes for African American Smokers
- ClinicalTrials.gov ID
- NCT00781599
- Acronym / sponsor ID
- 11500
- Conditions
- Smokers
- Keywords
- African american, smokers, smoking cessation, African American smokers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Nikki Nollen, PhD, MAUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 29 Oct 2008 (estimated)
- Results
- Posted 27 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Chantix, Behavioral: Standard CounselingChantix for 3 months and Standard Counseling |
| 2 | Experimental | Drug: Chantix, Behavioral: Adherence Counseling, Behavioral: Standard CounselingChantix for 3 months and Adherence Counseling |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- African American
- 18-75 years of age
- Smoke more than 10 cigarettes per day
- Have a functioning telephone number
- Be interested in quitting smoking
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChantixAlso: vareniclineChantix 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 | Drug | 1, 2 |
| Adherence CounselingInduction 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. | Behavioural | 2 |
| Standard CounselingVisit 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. | Behavioural | 1, 2 |
Primary outcome
Percent Compliance With Chantix
Time frame: 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.
3 secondary outcomes
Cotinine Verified 7 Day Point Prevalence Smoking Abstinence
Time frame: Month 3
Carbon Monoxide-verified Abstinence
Time frame: Month 1
Carbon Monoxide-verified Abstinence
Time frame: Month 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37142273Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Nollen, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chantix, Adherence Counseling and Standard Counseling in people with Smokers, run by Nikki Nollen, PhD, MA at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Compliance With Chantix (time frame: Months 1, 2, 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00781599, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2012.