Bladder CancerPhase 4NCT00666978

Health Education Counseling With or Without Bupropion in Helping African Americans Stop Smoking

A Phase 4 study testing smoking cessation intervention, bupropion hydrochloride and gene expression analysis in people with Bladder Cancer and Cervical Cancer, run by Lisa Sanderson Cox, PhD at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

RATIONALE: A stop-smoking plan that includes health education counseling and bupropion may help African-American smokers stop smoking. It is not yet known whether health education counseling is more effective with or without bupropion in helping African Americans stop smoking. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Bladder Cancer, Cervical Cancer, Esophageal Cancer
What is being tested?: smoking cessation intervention, bupropion hydrochloride and gene expression analysis
Type of treatment: Surgery or procedure, Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 540 participants
Where: 2 sitesUnited States
Study dates: Dec 2007to Jun 2010
Phase: Phase 4
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

DISEASE CHARACTERISTICS:

African American who has smoked ≤ 10 cigarettes per day for ≥ 2 years AND has smoked for ≥ 25 days within the past month
Not a heavy smoker
No other forms of tobacco within the past 30 days
Must be interested in stopping smoking
No other smoker in the household enrolled in this study

PATIENT CHARACTERISTICS:

Has a home address and a functioning telephone number
Not planning to move from the Kansas City metro area within the next 12 months
Not pregnant or nursing
Negative pregnancy test
No alcohol or substance abuse within the past year
Not currently drinking ≥ 14 alcoholic drinks per week
No binge drinking (5 or more drinks on one occasion) on at least two occasions within the past month
No history of seizures or head trauma
No history of bulimia or anorexia nervosa
No myocardial infarction within the past 30 days
No reported use of opiates, cocaine, or stimulants
No diabetes requiring oral hypoglycemics or insulin

PRIOR CONCURRENT THERAPY:

More than 30 days since prior nicotine replacement therapy, fluoxetine, clonidine, buspirone, or doxepin
No other concurrent medication that contains bupropion hydrochloride
No concurrent psychoactive medications

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, 66160-7357
Swope Health Central
Kansas City, Missouri, 64130

Other trials in United States

About this study

Official title: Enhancing Tobacco Use Treatment for African American Light Smokers

PURPOSE: This clinical trial is studying health education counseling and bupropion to see how well they work compared with a placebo and health education counseling in helping African Americans smokers stop smoking.

Read the detailed description

OBJECTIVES:

Primary

To evaluate the efficacy of bupropion hydrochloride and health education counseling vs placebo and health education counseling for smoking cessation among African Americans who are light smokers.

Secondary

To characterize CYP2A6 activity in African Americans who are light smokers by evaluating phenotype (3'hydroxycotinine/cotinine ratio [3HC/COT]) and CYP2A6 genotype.
To evaluate the relationship between CYP2A6 activity and smoking cessation outcomes.
To evaluate CYP2A6 genetic polymorphisms associated with nicotine and cotinine metabolism in African Americans who are light smokers.
To measure baseline cotinine and metabolite levels to evaluate the nicotine metabolism phenotype of 3HC/COT.
To evaluate the relationship between nicotine metabolism phenotype of 3HC/COT and smoking cessation outcomes.
To evaluate CYP2A6 genotype as a predictor of smoking cessation outcomes.

Tertiary

To characterize CYP2B6 activity in African Americans who are light smokers by evaluating phenotype and CYP2B6 genotype.
To evaluate the relationship between CYP2B6 activity and smoking cessation outcomes.
To measure steady state bupropion hydrochloride and metabolite levels to identify a bupropion metabolism phenotype.
To evaluate the relationship between bupropion hydrochloride metabolism phenotype and smoking cessation outcomes.
To evaluate the relationship between CYP2B6 genetic polymorphisms (genotype) and blood levels of bupropion hydrochloride and active metabolites (phenotype).
To determine the effects of CYP2B6 genotype as predictors of smoking cessation outcomes.

OUTLINE: Participants are randomized to one of two arms.

Arm I: Participants receive oral bupropion hydrochloride once or twice daily in weeks 0-6. Participants also undergo 6 sessions of health education counseling conducted in person during clinic visits in weeks 0, 3, and 7 and via telephone in weeks 1, 5, and 16. The health education counseling sessions include providing information about the risks of continued smoking and the benefits of quitting, developing a quit plan, outlining a concrete quit day preparation plan, discussing strategies for successful quitting, building social support, reducing stress, recognizing and managing withdrawal and craving, overcoming barriers to abstinence, and using medication for smoking cessation. Participants receive Kick It at Swope: Stop Smoking Guide, a culturally-sensitive smoking cessation guide, to review with their study counselor during the first counseling session.
Arm II: Participants receive an oral placebo once or twice daily in weeks 0-6. Participants also undergo health education counseling as in arm I.

Participants complete baseline questionnaires about demographics, smoking history, and psychometrics, including the following: racial identity, depressive symptoms, alcohol use, stress, smoking consequences, social support, environmental influences of smoking, adherence to study medication, nicotine withdrawal, craving, and mood.

Participants undergo serum sample collection in weeks 0 and 3. To standardize the time since the last cigarette, participants are asked to smoke one cigarette prior to serum sample collection in week 0. Samples are analyzed for nicotine metabolism phenotype and bupropion hydrochloride metabolism phenotype by liquid chromatography and mass spectrometry and CYP2A6 and CYP2B6 genotype by polymerase chain reaction and polymorphism analysis. Participants who self-report abstinence also undergo saliva sample collection in weeks 7 and 26 to measure cotinine levels to verify smoking status.

After completion of study intervention, participants are followed at 6 months.

Conditions: Bladder Cancer, Cervical Cancer, Esophageal Cancer, Gastric Cancer, Head and Neck Cancer, Kidney Cancer
Being tested: smoking cessation intervention, bupropion hydrochloride, gene expression analysis, polymerase chain reaction, counseling intervention
Keywords: bladder cancer, cervical cancer, esophageal cancer, gastric cancer, renal cell carcinoma, adult primary liver cancer, non-small cell lung cancer, small cell lung cancer, pancreatic cancer, hypopharyngeal cancer, laryngeal cancer, lip and oral cavity cancer, nasopharyngeal cancer, oropharyngeal cancer, paranasal sinus and nasal cavity cancer, adult acute myeloid leukemia, tobacco use disorder
Medical subject headings: Urinary Bladder Neoplasms, Uterine Cervical Neoplasms, Esophageal Neoplasms, Stomach Neoplasms, Head and Neck Neoplasms, Kidney Neoplasms, Leukemia, Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

smoking cessation interventionBehavioural
bupropion hydrochlorideDrug
gene expression analysisGenetic
polymerase chain reactionGenetic
counseling interventionOther
educational interventionOther
psychosocial assessment and careProcedure or surgery

Study groups in NCT00666978
Study group	Role	What they receive
Bupropion Arm	Experimental	Subjects undergo smoking cessation intervention and take bupropion. Receives: Behavioral: smoking cessation intervention; Drug: bupropion hydrochloride; Genetic: gene expression analysis; Genetic: polymerase chain reaction; Other: counseling intervention; Other: educational intervention; Procedure: psychosocial assessment and care
Health Education Arm	Placebo comparator	Subjects receive counseling intervention and take placebo. Receives: Behavioral: smoking cessation intervention; Genetic: gene expression analysis; Genetic: polymerase chain reaction; Other: counseling intervention; Other: educational intervention; Procedure: psychosocial assessment and care

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Salivary Cotinine-verified Smoking Abstinence at 6 Months
Salivary cotinine-verified smoking abstinence at 6 months. A cut point of 15 ng/ml was used to differentiate smokers from nonsmokers.
Measured: 6 months

Secondary outcomes (3)

Number of Slow and Fast Metabolizers by Metabolite Ratio
Analyzed CYP2A6 by activity, called the nicotine metabolite ratio using a split between slow and fast metabolism at 0.31.
The variants present in people in the slow genotype group include *17, *20, *23,*27, *35, *9, *2, *25, *26, and *4. The fast metabolizers have none of the variant alleles tested.
Blood samples were collected for 3HC/COT ratio at Week 0.
Measured: Weeks 0
Number of Participants for Each CYP2B6 Allele
We genotyped CYP2B6 in 268 from the Bupropion arm as this polymorphism is related to bupropion metabolism.
Measured: Week 3
Number of Slow and Fast Metabolizers by Genotype
Analyzed CYP2A6 by genotype. The variants present in people in the slow genotype group include *17, *20, *23,*27, *35, *9, *2, *25, *26, and *4. The fast metabolizers have none of the variant alleles tested.
Slow metabolizers have any reduction or loss of function variant. Fast metabolizers are *1/*1 genotype by exclusion.
Measured: Week 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2007Jun 2010

First posted25 Apr 2008 (estimated)
Study startDec 2007
Primary completionJun 2010
Study completionJun 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 (8)Papers the sponsor has linked to this study.
Other trials for Bladder CancerStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 540 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00666978
Sponsor's protocol ID: 10332
Other IDs: R01CA091912, KUMC-HSC-10332, KUMC-070313
Status last verified: Oct 2017
First submitted: 24 Apr 2008
Last updated: 13 Nov 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.
PubMed 37230961
Chenoweth MJ, Peng AR, Zhu AZX, Cox LS, Nollen NL, Ahluwalia JS, Benowitz NL, Knight J, Swardfager W, Tyndale RF. Does sex alter the relationship between CYP2B6 variation, hydroxybupropion concentration and bupropion-aided smoking cessation in African Americans? A moderated mediation analysis. Addiction. 2022 Jun;117(6):1715-1724. doi: 10.1111/add.15742. Epub 2021 Dec 3.
PubMed 34791718
Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.
PubMed 34611902
El-Boraie A, Chenoweth MJ, Pouget JG, Benowitz NL, Fukunaga K, Mushiroda T, Kubo M, Nollen NL, Sanderson Cox L, Lerman C, Knight J, Tyndale RF. Transferability of Ancestry-Specific and Cross-Ancestry CYP2A6 Activity Genetic Risk Scores in African and European Populations. Clin Pharmacol Ther. 2021 Oct;110(4):975-985. doi: 10.1002/cpt.2135. Epub 2021 Jan 1.
PubMed 33300144
Nollen NL, Mayo MS, Ahluwalia JS, Tyndale RF, Benowitz NL, Faseru B, Buchanan TS, Cox LS. Factors associated with discontinuation of bupropion and counseling among African American light smokers in a randomized clinical trial. Ann Behav Med. 2013 Dec;46(3):336-48. doi: 10.1007/s12160-013-9510-x.
PubMed 23733379
Clausius RL, Krebill R, Mayo MS, Bronars C, Martin L, Ahluwalia JS, Cox LS. Evaluation of the brief questionnaire of smoking urges in Black light smokers. Nicotine Tob Res. 2012 Sep;14(9):1110-4. doi: 10.1093/ntr/ntr267. Epub 2012 Jan 12.
PubMed 22241828
Berg CJ, Cox LS, Choi WS, Mayo MS, Krebill R, Bronars CA, Ahluwalia JS. Assessment of depression among African American light smokers. J Health Psychol. 2012 Mar;17(2):197-206. doi: 10.1177/1359105311414953. Epub 2011 Jul 20.
PubMed 21775497
Cox LS, Faseru B, Mayo MS, Krebill R, Snow TS, Bronars CA, Nollen NL, Choi WS, Okuyemi KS, Salzman GA, Benowitz NL, Tyndale RF, Ahluwalia JS. Design, baseline characteristics, and retention of African American light smokers into a randomized trial involving biological data. Trials. 2011 Jan 25;12:22. doi: 10.1186/1745-6215-12-22.
PubMed 21266057

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma

All Bladder Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Enhancing Tobacco Use Treatment for African American Light Smokers
ClinicalTrials.gov ID: NCT00666978
Acronym / sponsor ID: 10332
Conditions: Bladder Cancer, Cervical Cancer, Esophageal Cancer, Gastric Cancer, Head and Neck Cancer, Kidney Cancer
Keywords: bladder cancer, cervical cancer, esophageal cancer, gastric cancer, renal cell carcinoma, adult primary liver cancer, non-small cell lung cancer, small cell lung cancer
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 540 participants (actual)
Lead sponsor: Lisa Sanderson Cox, PhDUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: Dec 2007
Primary completion: Jun 2010 (actual)
Study completion: Jun 2010 (actual)
First posted: 25 Apr 2008 (estimated)
Results: Posted 24 Jul 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

OBJECTIVES:

Primary

To evaluate the efficacy of bupropion hydrochloride and health education counseling vs placebo and health education counseling for smoking cessation among African Americans who are light smokers.

Secondary

To characterize CYP2A6 activity in African Americans who are light smokers by evaluating phenotype (3'hydroxycotinine/cotinine ratio [3HC/COT]) and CYP2A6 genotype.
To evaluate the relationship between CYP2A6 activity and smoking cessation outcomes.
To evaluate CYP2A6 genetic polymorphisms associated with nicotine and cotinine metabolism in African Americans who are light smokers.
To measure baseline cotinine and metabolite levels to evaluate the nicotine metabolism phenotype of 3HC/COT.
To evaluate the relationship between nicotine metabolism phenotype of 3HC/COT and smoking cessation outcomes.
To evaluate CYP2A6 genotype as a predictor of smoking cessation outcomes.

Tertiary

To characterize CYP2B6 activity in African Americans who are light smokers by evaluating phenotype and CYP2B6 genotype.
To evaluate the relationship between CYP2B6 activity and smoking cessation outcomes.
To measure steady state bupropion hydrochloride and metabolite levels to identify a bupropion metabolism phenotype.
To evaluate the relationship between bupropion hydrochloride metabolism phenotype and smoking cessation outcomes.
To evaluate the relationship between CYP2B6 genetic polymorphisms (genotype) and blood levels of bupropion hydrochloride and active metabolites (phenotype).
To determine the effects of CYP2B6 genotype as predictors of smoking cessation outcomes.

OUTLINE: Participants are randomized to one of two arms.

Arm I: Participants receive oral bupropion hydrochloride once or twice daily in weeks 0-6. Participants also undergo 6 sessions of health education counseling conducted in person during clinic visits in weeks 0, 3, and 7 and via telephone in weeks 1, 5, and 16. The health education counseling sessions include providing information about the risks of continued smoking and the benefits of quitting, developing a quit plan, outlining a concrete quit day preparation plan, discussing strategies for successful quitting, building social support, reducing stress, recognizing and managing withdrawal and craving, overcoming barriers to abstinence, and using medication for smoking cessation. Participants receive Kick It at Swope: Stop Smoking Guide, a culturally-sensitive smoking cessation guide, to review with their study counselor during the first counseling session.
Arm II: Participants receive an oral placebo once or twice daily in weeks 0-6. Participants also undergo health education counseling as in arm I.

After completion of study intervention, participants are followed at 6 months.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Bupropion Arm	Experimental	Behavioral: smoking cessation intervention, Drug: bupropion hydrochloride, Genetic: gene expression analysis, Genetic: polymerase chain reaction, Other: counseling intervention, Other: educational intervention, Procedure: psychosocial assessment and careSubjects undergo smoking cessation intervention and take bupropion.
Health Education Arm	Placebo comparator	Behavioral: smoking cessation intervention, Genetic: gene expression analysis, Genetic: polymerase chain reaction, Other: counseling intervention, Other: educational intervention, Procedure: psychosocial assessment and careSubjects receive counseling intervention and take placebo.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

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
smoking cessation intervention	Behavioural	Bupropion Arm, Health Education Arm
bupropion hydrochloride	Drug	Bupropion Arm
gene expression analysis	Genetic	Bupropion Arm, Health Education Arm
polymerase chain reaction	Genetic	Bupropion Arm, Health Education Arm
counseling intervention	Other	Bupropion Arm, Health Education Arm
educational intervention	Other	Bupropion Arm, Health Education Arm
psychosocial assessment and care	Procedure or surgery	Bupropion Arm, Health Education Arm

Primary outcome

Number of Participants With Salivary Cotinine-verified Smoking Abstinence at 6 Months
Time frame: 6 months
Salivary cotinine-verified smoking abstinence at 6 months. A cut point of 15 ng/ml was used to differentiate smokers from nonsmokers.

3 secondary outcomes

Number of Slow and Fast Metabolizers by Metabolite Ratio
Time frame: Weeks 0
Number of Participants for Each CYP2B6 Allele
Time frame: Week 3
Number of Slow and Fast Metabolizers by Genotype
Time frame: Week 0

Results and safety

Results posted to the registry on 24 Jul 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bupropion Arm	270	192
Placebo Arm	270	187

Primary outcome: Number of Participants With Salivary Cotinine-verified Smoking Abstinence at 6 Months

Time frame: 6 months. Count of participants. Unit: Participants

Measure	Bupropion Arm n = 270	Placebo Arm n = 270
Value	36	27

Bupropion Arm vs Placebo Arm: Odds Ratio (OR): 1.39 (95% CI 0.82 to 2.35), p = .23, t-test, 2 sided

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 16 weeks. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bupropion Arm	8 of 270 (3%)	46 of 270 (17%)	0 of 270
Placebo Arm	13 of 270 (4.8%)	29 of 270 (10.7%)	0 of 270

Limitations and caveats (from the sponsor): Over half of the participants who expressed interest in this study were ineligible according to study protocol. The lack of assessment between standardized assessment points limited the ability to characterize the process of relapse.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37230961Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.
Derived from this study: PubMed 34791718Chenoweth MJ, Peng AR, Zhu AZX, Cox LS, Nollen NL, Ahluwalia JS, Benowitz NL, Knight J, Swardfager W, Tyndale RF. Does sex alter the relationship between CYP2B6 variation, hydroxybupropion concentration and bupropion-aided smoking cessation in African Americans? A moderated mediation analysis. Addiction. 2022 Jun;117(6):1715-1724. doi: 10.1111/add.15742. Epub 2021 Dec 3.
Derived from this study: PubMed 34611902Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.
Derived from this study: PubMed 33300144El-Boraie A, Chenoweth MJ, Pouget JG, Benowitz NL, Fukunaga K, Mushiroda T, Kubo M, Nollen NL, Sanderson Cox L, Lerman C, Knight J, Tyndale RF. Transferability of Ancestry-Specific and Cross-Ancestry CYP2A6 Activity Genetic Risk Scores in African and European Populations. Clin Pharmacol Ther. 2021 Oct;110(4):975-985. doi: 10.1002/cpt.2135. Epub 2021 Jan 1.
Derived from this study: PubMed 23733379Nollen NL, Mayo MS, Ahluwalia JS, Tyndale RF, Benowitz NL, Faseru B, Buchanan TS, Cox LS. Factors associated with discontinuation of bupropion and counseling among African American light smokers in a randomized clinical trial. Ann Behav Med. 2013 Dec;46(3):336-48. doi: 10.1007/s12160-013-9510-x.
Derived from this study: PubMed 22241828Clausius RL, Krebill R, Mayo MS, Bronars C, Martin L, Ahluwalia JS, Cox LS. Evaluation of the brief questionnaire of smoking urges in Black light smokers. Nicotine Tob Res. 2012 Sep;14(9):1110-4. doi: 10.1093/ntr/ntr267. Epub 2012 Jan 12.
Derived from this study: PubMed 21775497Berg CJ, Cox LS, Choi WS, Mayo MS, Krebill R, Bronars CA, Ahluwalia JS. Assessment of depression among African American light smokers. J Health Psychol. 2012 Mar;17(2):197-206. doi: 10.1177/1359105311414953. Epub 2011 Jul 20.
Derived from this study: PubMed 21266057Cox LS, Faseru B, Mayo MS, Krebill R, Snow TS, Bronars CA, Nollen NL, Choi WS, Okuyemi KS, Salzman GA, Benowitz NL, Tyndale RF, Ahluwalia JS. Design, baseline characteristics, and retention of African American light smokers into a randomized trial involving biological data. Trials. 2011 Jan 25;12:22. doi: 10.1186/1745-6215-12-22.

Related trials for Bladder Cancer

RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma

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.

Lisa S. Cox, PhD principal investigator

University of Kansas

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 13 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jul 2017). 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?

Number of Participants With Salivary Cotinine-verified Smoking Abstinence at 6 Months (time frame: 6 months). 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 NCT00666978, which also lists 8 linked publications.

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 13 Nov 2017.