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Trial record 2 of 3 for:    "Nasopharyngeal Carcinoma" | "Dopamine Uptake Inhibitors"

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

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ClinicalTrials.gov Identifier: NCT00666978
Recruitment Status : Completed
First Posted : April 25, 2008
Results First Posted : July 24, 2017
Last Update Posted : November 13, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Lisa Sanderson Cox, PhD, University of Kansas Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Bladder Cancer
Cervical Cancer
Esophageal Cancer
Gastric Cancer
Head and Neck Cancer
Kidney Cancer
Leukemia
Liver Cancer
Lung Cancer
Pancreatic Cancer
Tobacco Use Disorder
Interventions 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
Enrollment 540
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bupropion Arm Placebo Arm
Hide Arm/Group Description 270 African American adults received bupropion (150mg bid) for 7 weeks in addition to health education counseling. 270 African American adults received placebo for 7 weeks in addition to health education counseling.
Period Title: Overall Study
Started 270 270
Completed 192 187
Not Completed 78 83
Arm/Group Title Bupropion Arm Placebo Arm Total
Hide Arm/Group Description 270 African American adults received bupropion (150mg bid) for 7 weeks in addition to health education counseling. 270 African American adults received placebo for 7 weeks in addition to health education counseling. Total of all reporting groups
Overall Number of Baseline Participants 270 270 540
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 270 participants 270 participants 540 participants
46.8  (11.1) 46.2  (11.5) 46.5  (11.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 270 participants 270 participants 540 participants
Female
174
  64.4%
183
  67.8%
357
  66.1%
Male
96
  35.6%
87
  32.2%
183
  33.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 270 participants 270 participants 540 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
270
 100.0%
270
 100.0%
540
 100.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 270 participants 270 participants 540 participants
270 270 540
Married or living with partner   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 269 participants 270 participants 539 participants
91
  33.8%
75
  27.8%
166
  30.8%
[1]
Measure Analysis Population Description: One participant refused the question.
Monthly family income <$1800   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 267 participants 267 participants 534 participants
169
  63.3%
158
  59.2%
327
  61.2%
[1]
Measure Analysis Population Description: 6 participants refused the question.
Education > or = high school   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 269 participants 270 participants 539 participants
225
  83.6%
229
  84.8%
454
  84.2%
[1]
Measure Analysis Population Description: One participant refused the question.
Weight  
Mean (Standard Deviation)
Unit of measure:  Lbs
Number Analyzed 270 participants 270 participants 540 participants
196.1  (51.8) 194.8  (54.0) 195.5  (52.9)
BMI   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m 2
Number Analyzed 269 participants 270 participants 539 participants
31.1  (7.6) 31.1  (8.1) 31.1  (7.9)
[1]
Measure Analysis Population Description: One participant refused to collect weight.
Depression(CESD-10) score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 269 participants 270 participants 539 participants
7.2  (4.9) 8.2  (5.5) 7.7  (5.2)
[1]
Measure Description: CESD-10 assessed distress associated with depressive symptoms: possible total score ranges from 0 to 30, with a score of 10 or greater reflecting clinically significant depression.
[2]
Measure Analysis Population Description: One participant refused the questions.
Stress (PSS-4)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 269 participants 270 participants 539 participants
4.9  (3.1) 5.5  (3.3) 5.2  (3.2)
[1]
Measure Description: PSS-4 assessed self-appraised global stress: possible total score ranges from 0 to 16. Higher scores indicate more stress.
[2]
Measure Analysis Population Description: One participant refused to answer.
Serum Cotinine   [1] 
Mean (Standard Deviation)
Unit of measure:  Ng/ml
Number Analyzed 269 participants 267 participants 536 participants
268.7  (160.2) 283.0  (151.2) 275.8  (155.8)
[1]
Measure Analysis Population Description: 4 participants had samples that were unable to be analyzed.
Exhaled Carbon monoxide   [1] 
Mean (Standard Deviation)
Unit of measure:  Ppm
Number Analyzed 202 participants 209 participants 411 participants
15.8  (9.4) 17.1  (10.5) 16.4  (10.0)
[1]
Measure Analysis Population Description: Exhaled carbon monoxide was added after the study began and was collected only on 411 of 540 participants.
Cigarettes per day  
Mean (Standard Deviation)
Unit of measure:  Cigarettes per day
Number Analyzed 270 participants 270 participants 540 participants
8.0  (2.6) 7.9  (2.4) 8.0  (2.5)
Fagerstrom Test for Nicotine Dependence- 6 item   [1] 
Mean (Standard Deviation)
Unit of measure:  Score
Number Analyzed 270 participants 270 participants 540 participants
3.1  (1.7) 3.3  (1.7) 3.2  (1.7)
[1]
Measure Description: FTND assessed nicotine dependence: possible total score ranges from 0 to 10. 0 indicates minimum physical nicotine dependence and 10 indicates maximum physical nicotine dependence.
Time to first cigarette,< or = 30 minutes  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 270 participants 270 participants 540 participants
191
  70.7%
199
  73.7%
390
  72.2%
Smoke Menthol Cigarettes  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 270 participants 270 participants 540 participants
224
  83.0%
228
  84.4%
452
  83.7%
Quit Attempts   [1] 
Mean (Standard Deviation)
Unit of measure:  Quit Attempts
Number Analyzed 270 participants 270 participants 540 participants
3.5  (7.9) 3.9  (7.4) 3.7  (7.7)
[1]
Measure Description: Number of 24-hour quit attempts made in the past year.
Pharmacotherapy use during most recent quit attempt  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 270 participants 270 participants 540 participants
72
  26.7%
61
  22.6%
133
  24.6%
Age of first cigarette  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 270 participants 270 participants 540 participants
17.5  (5.8) 18.1  (7.3) 17.6  (5.9)
Age started smoking regularly   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 269 participants 270 participants 539 participants
21.1  (6.7) 21.3  (7.4) 21.1  (7.1)
[1]
Measure Analysis Population Description: One participant declined to respond.
Motivation Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 270 participants 270 participants 540 participants
9.7  (0.8) 9.8  (0.7) 9.7  (0.8)
[1]
Measure Description: Motivation to quit smoking scale asking about how important it is to quit smoking in the next week. 1 item scale. Scale of 0 = not important and 10 = extremely important.
Confidence Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 270 participants 270 participants 540 participants
7.9  (2.1) 7.8  (2.0) 7.9  (2.4)
[1]
Measure Description: Confidence to quit smoking scale asking about how confident you are that you could quit smoking completely in the next week. 1 item scale. Scale of 0 = not confident and 10 = extremely confident.
Smoke-free household  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 270 participants 270 participants 540 participants
65
  24.1%
67
  24.8%
132
  24.4%
California Tobacco Survey: Inhale deeply   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 270 participants 270 participants 540 participants
65
  24.1%
61
  22.6%
126
  23.3%
[1]
Measure Description:

Question asks "Which statement best describes how or whether you inhale?" Response options include 'I inhale deeply into my chest', I inhale partly into my chest', I inhale as far back as my throat', 'I inhale back into my throat', 'I just puff, I don't really inhale'.

Reporting number of participants who answered 'I inhale deeply into my chest'.

1.Primary Outcome
Title Number of Participants With Salivary Cotinine-verified Smoking Abstinence at 6 Months
Hide Description Salivary cotinine-verified smoking abstinence at 6 months. A cut point of 15 ng/ml was used to differentiate smokers from nonsmokers.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bupropion Arm Placebo Arm
Hide Arm/Group Description:
270 African American adults received bupropion (150mg bid) for 7 weeks in addition to health education counseling.
270 African American adults received placebo for 7 weeks in addition to health education counseling.
Overall Number of Participants Analyzed 270 270
Measure Type: Count of Participants
Unit of Measure: Participants
36
  13.3%
27
  10.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bupropion Arm, Placebo Arm
Comments Based on our previous studies, sample size was determined a priori assuming a two-sided x2 test with a type I error rate of .05, a power of 80%, and a cotinine-verified abstinence rate of 15% in the placebo group and 25% in the bupropion SR group at week 26, with the assumption that those lost to follow-up would be imputed as smokers.
Type of Statistical Test Superiority
Comments The x2 test was used to determine whether there was a difference between treatment groups (bupropion SR vs placebo) in verified 7-day point prevalence abstinence at week 26, imputing the missing participants as smokers.
Statistical Test of Hypothesis P-Value .23
Comments All tests of statistical significance were two-sided, and all P values less than .05 were considered statistically significant.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.39
Confidence Interval (2-Sided) 95%
0.82 to 2.35
Estimation Comments Raw proportions were used to estimate the verified cessation rate in each group and corresponding odds ratio along with its 95% confidence interval .
2.Secondary Outcome
Title Number of Slow and Fast Metabolizers by Metabolite Ratio
Hide Description

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.

Time Frame Weeks 0
Hide Outcome Measure Data
Hide Analysis Population Description
This variant is related to nicotine metabolism and was collected from all study participants but not analyzed by study arm as it does not relate to the study medication. Data pre-specified to be collected and reported as a single arm.
Arm/Group Title All Study Participants
Hide Arm/Group Description:
All study participants were African American adults and received either bupropion (150mg bid) for 7 weeks in addition to health education counseling or placebo for 7 weeks in addition to health education counseling.
Overall Number of Participants Analyzed 450
Measure Type: Count of Participants
Unit of Measure: Participants
Fast Metabolizers by Nicotine Metabolite Ratio
236
  52.4%
Slow Metabolizers by Nicotine Metabolite Ratio
214
  47.6%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Study Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0022
Comments This reflects Week 7.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.95 to 0.99
Estimation Comments This reflects Week 7.
3.Secondary Outcome
Title Number of Participants for Each CYP2B6 Allele
Hide Description We genotyped CYP2B6 in 268 from the Bupropion arm as this polymorphism is related to bupropion metabolism.
Time Frame Week 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bupropion Arm
Hide Arm/Group Description:
270 African American adults received bupropion (150mg bid)for 7 weeks in addition to health education counseling.
Overall Number of Participants Analyzed 268
Measure Type: Count of Participants
Unit of Measure: Participants
CYP2B6*4 Allele Frequency
2
   0.7%
CYP2B6*5 Allele Frequency
6
   2.2%
CYP2B6*6 Allele Frequency
95
  35.4%
CYP2B6*9 Allele Frequency
0
   0.0%
CYP2B6*16 Allele Frequency
0
   0.0%
CYP2B6*18 Allele Frequency
17
   6.3%
CYP2B6*22 Allele Frequency
6
   2.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bupropion Arm
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments Analysis relied on examining quit rates using linear regression, where the hydroxybupropion was a significant predictor of smoking cessation. CYP2B6 genotype was not a direct significant predictor of cessation in either the placebo or bupropion arm.
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.82
Estimation Comments Bupropion adherent individuals with higher hydroxybupropion levels were more likely to be abstinent at Weeks 3, 7 and 26 compared to individuals with lower hydroxybupropion levels.
4.Secondary Outcome
Title Number of Slow and Fast Metabolizers by Genotype
Hide Description

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.

Time Frame Week 0
Hide Outcome Measure Data
Hide Analysis Population Description
This variant is related to nicotine metabolism and was collected from all study participants but not analyzed by study arm as it does not relate to the study medication. Data pre-specified to be collected and reported as a single arm. Blood was unable to be analyzed for CYP2A6 genotype for 6 participants.
Arm/Group Title All Study Participants
Hide Arm/Group Description:
All study participants were African American adults and received either bupropion (150mg bid) for 7 weeks in addition to health education counseling or placebo for 7 weeks in addition to health education counseling.
Overall Number of Participants Analyzed 534
Measure Type: Count of Participants
Unit of Measure: Participants
Slow Metabolizers by Genotype
265
  49.6%
Fast Metabolizers by Genotype
269
  50.4%
Time Frame 16 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bupropion Arm Placebo Arm
Hide Arm/Group Description 270 African American adults received bupropion (150mg bid) for 7 weeks in addition to health education counseling. 270 African American adults received placebo for 7 weeks in addition to health education counseling.
All-Cause Mortality
Bupropion Arm Placebo Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   0/270 (0.00%)      0/270 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Bupropion Arm Placebo Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/270 (2.96%)      13/270 (4.81%)    
Cardiac disorders     
Atrioventricular block  1  1/270 (0.37%)  1 0/270 (0.00%)  0
Chest Pain  1  1/270 (0.37%)  1 0/270 (0.00%)  0
Coagulation  1  0/270 (0.00%)  0 1/270 (0.37%)  1
Gastrointestinal disorders     
Toothache  1  0/270 (0.00%)  0 1/270 (0.37%)  1
Infections and infestations     
Lung infection  1  0/270 (0.00%)  0 2/270 (0.74%)  2
MIddle ear infection  1  0/270 (0.00%)  0 1/270 (0.37%)  1
Musculoskeletal and connective tissue disorders     
Muscle Weakness  1  1/270 (0.37%)  1 0/270 (0.00%)  0
Upper extremity dysfunction  1  1/270 (0.37%)  1 0/270 (0.00%)  0
Arthritis  1  0/270 (0.00%)  0 1/270 (0.37%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Treatment related secondary malignancy  1  0/270 (0.00%)  0 2/270 (0.74%)  2
Tumor pain  1  0/270 (0.00%)  0 1/270 (0.37%)  1
Nervous system disorders     
Syncope  1  1/270 (0.37%)  1 0/270 (0.00%)  0
Acoustic nerve disorder  1  0/270 (0.00%)  0 1/270 (0.37%)  1
Psychiatric disorders     
Insomnia  1  1/270 (0.37%)  1 1/270 (0.37%)  1
Depression  1  0/270 (0.00%)  0 2/270 (0.74%)  2
Personality Change  1  1/270 (0.37%)  1 0/270 (0.00%)  0
Skin and subcutaneous tissue disorders     
Infection, Skin  1  1/270 (0.37%)  1 0/270 (0.00%)  0
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Bupropion Arm Placebo Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   46/270 (17.04%)      29/270 (10.74%)    
Gastrointestinal disorders     
Nausea  1  11/270 (4.07%)  11 5/270 (1.85%)  5
Nervous system disorders     
Headache  1  9/270 (3.33%)  9 15/270 (5.56%)  15
Psychiatric disorders     
Insomnia  1  26/270 (9.63%)  26 9/270 (3.33%)  9
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Lisa Sanderson Cox
Organization: University of Kansas Medical Center
Phone: 913-588-2643
EMail: lcox@kumc.edu
Layout table for additonal information
Responsible Party: Lisa Sanderson Cox, PhD, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT00666978     History of Changes
Other Study ID Numbers: 10332
R01CA091912 ( U.S. NIH Grant/Contract )
KUMC-HSC-10332
KUMC-070313
First Submitted: April 24, 2008
First Posted: April 25, 2008
Results First Submitted: April 17, 2017
Results First Posted: July 24, 2017
Last Update Posted: November 13, 2017