Trial Outcomes & Findings for Health Education Counseling With or Without Bupropion in Helping African Americans Stop Smoking (NCT NCT00666978)

Last Updated: 2017-11-13

Results Overview

Salivary cotinine-verified smoking abstinence at 6 months. A cut point of 15 ng/ml was used to differentiate smokers from nonsmokers.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

540 participants

Primary outcome timeframe

6 months

Results posted on

2017-11-13

Participant Flow

Participant milestones

Participant milestones
Measure	Bupropion Arm 270 African American adults received bupropion (150mg bid) for 7 weeks in addition to health education counseling.	Placebo Arm 270 African American adults received placebo for 7 weeks in addition to health education counseling.
Overall Study STARTED	270	270
Overall Study COMPLETED	192	187
Overall Study NOT COMPLETED	78	83

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

One participant refused the question.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 6 months

Salivary cotinine-verified smoking abstinence at 6 months. A cut point of 15 ng/ml was used to differentiate smokers from nonsmokers.

Outcome measures

Outcome measures
Measure	Bupropion Arm n=270 Participants 270 African American adults received bupropion (150mg bid) for 7 weeks in addition to health education counseling.	Placebo Arm n=270 Participants 270 African American adults received placebo for 7 weeks in addition to health education counseling.
Number of Participants With Salivary Cotinine-verified Smoking Abstinence at 6 Months	36 Participants	27 Participants

SECONDARY outcome

Timeframe: Weeks 0

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Bupropion Arm n=450 Participants 270 African American adults received bupropion (150mg bid) for 7 weeks in addition to health education counseling.	Placebo Arm 270 African American adults received placebo for 7 weeks in addition to health education counseling.
Number of Slow and Fast Metabolizers by Metabolite Ratio Fast Metabolizers by Nicotine Metabolite Ratio	236 Participants	—
Number of Slow and Fast Metabolizers by Metabolite Ratio Slow Metabolizers by Nicotine Metabolite Ratio	214 Participants	—

SECONDARY outcome

Timeframe: Week 3

We genotyped CYP2B6 in 268 from the Bupropion arm as this polymorphism is related to bupropion metabolism.

Outcome measures

Outcome measures
Measure	Bupropion Arm n=268 Participants 270 African American adults received bupropion (150mg bid) for 7 weeks in addition to health education counseling.	Placebo Arm 270 African American adults received placebo for 7 weeks in addition to health education counseling.
Number of Participants for Each CYP2B6 Allele CYP2B6*4 Allele Frequency	2 Participants	—
Number of Participants for Each CYP2B6 Allele CYP2B6*5 Allele Frequency	6 Participants	—
Number of Participants for Each CYP2B6 Allele CYP2B6*6 Allele Frequency	95 Participants	—
Number of Participants for Each CYP2B6 Allele CYP2B6*9 Allele Frequency	0 Participants	—
Number of Participants for Each CYP2B6 Allele CYP2B6*16 Allele Frequency	0 Participants	—
Number of Participants for Each CYP2B6 Allele CYP2B6*18 Allele Frequency	17 Participants	—
Number of Participants for Each CYP2B6 Allele CYP2B6*22 Allele Frequency	6 Participants	—

SECONDARY outcome

Timeframe: Week 0

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.

Outcome measures

Outcome measures
Measure	Bupropion Arm n=534 Participants 270 African American adults received bupropion (150mg bid) for 7 weeks in addition to health education counseling.	Placebo Arm 270 African American adults received placebo for 7 weeks in addition to health education counseling.
Number of Slow and Fast Metabolizers by Genotype Slow Metabolizers by Genotype	265 Participants	—
Number of Slow and Fast Metabolizers by Genotype Fast Metabolizers by Genotype	269 Participants	—

Adverse Events

Bupropion Arm

Serious events: 8 serious events

Other events: 46 other events

Deaths: 0 deaths

Placebo Arm

Serious events: 13 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Bupropion Arm n=270 participants at risk 270 African American adults received bupropion (150mg bid) for 7 weeks in addition to health education counseling.	Placebo Arm n=270 participants at risk 270 African American adults received placebo for 7 weeks in addition to health education counseling.
Cardiac disorders Atrioventricular block	0.37% 1/270 • Number of events 1 • 16 weeks	0.00% 0/270 • 16 weeks
Cardiac disorders Chest Pain	0.37% 1/270 • Number of events 1 • 16 weeks	0.00% 0/270 • 16 weeks
Skin and subcutaneous tissue disorders Infection, Skin	0.37% 1/270 • Number of events 1 • 16 weeks	0.00% 0/270 • 16 weeks
Psychiatric disorders Insomnia	0.37% 1/270 • Number of events 1 • 16 weeks	0.37% 1/270 • Number of events 1 • 16 weeks
Musculoskeletal and connective tissue disorders Muscle Weakness	0.37% 1/270 • Number of events 1 • 16 weeks	0.00% 0/270 • 16 weeks
Nervous system disorders Syncope	0.37% 1/270 • Number of events 1 • 16 weeks	0.00% 0/270 • 16 weeks
Musculoskeletal and connective tissue disorders Upper extremity dysfunction	0.37% 1/270 • Number of events 1 • 16 weeks	0.00% 0/270 • 16 weeks
Nervous system disorders Acoustic nerve disorder	0.00% 0/270 • 16 weeks	0.37% 1/270 • Number of events 1 • 16 weeks
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/270 • 16 weeks	0.37% 1/270 • Number of events 1 • 16 weeks
Cardiac disorders Coagulation	0.00% 0/270 • 16 weeks	0.37% 1/270 • Number of events 1 • 16 weeks
Psychiatric disorders Depression	0.00% 0/270 • 16 weeks	0.74% 2/270 • Number of events 2 • 16 weeks
Infections and infestations Lung infection	0.00% 0/270 • 16 weeks	0.74% 2/270 • Number of events 2 • 16 weeks
Infections and infestations MIddle ear infection	0.00% 0/270 • 16 weeks	0.37% 1/270 • Number of events 1 • 16 weeks
Gastrointestinal disorders Toothache	0.00% 0/270 • 16 weeks	0.37% 1/270 • Number of events 1 • 16 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Treatment related secondary malignancy	0.00% 0/270 • 16 weeks	0.74% 2/270 • Number of events 2 • 16 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	0.00% 0/270 • 16 weeks	0.37% 1/270 • Number of events 1 • 16 weeks
Psychiatric disorders Personality Change	0.37% 1/270 • Number of events 1 • 16 weeks	0.00% 0/270 • 16 weeks

Other adverse events

Other adverse events
Measure	Bupropion Arm n=270 participants at risk 270 African American adults received bupropion (150mg bid) for 7 weeks in addition to health education counseling.	Placebo Arm n=270 participants at risk 270 African American adults received placebo for 7 weeks in addition to health education counseling.
Nervous system disorders Headache	3.3% 9/270 • Number of events 9 • 16 weeks	5.6% 15/270 • Number of events 15 • 16 weeks
Psychiatric disorders Insomnia	9.6% 26/270 • Number of events 26 • 16 weeks	3.3% 9/270 • Number of events 9 • 16 weeks
Gastrointestinal disorders Nausea	4.1% 11/270 • Number of events 11 • 16 weeks	1.9% 5/270 • Number of events 5 • 16 weeks

Additional Information

Lisa Sanderson Cox

University of Kansas Medical Center

Phone: 913-588-2643

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Bupropion Arm n=270 Participants 270 African American adults received bupropion (150mg bid) for 7 weeks in addition to health education counseling.	Placebo Arm n=270 Participants 270 African American adults received placebo for 7 weeks in addition to health education counseling.	Total n=540 Participants Total of all reporting groups
Age, Continuous	46.8 years STANDARD_DEVIATION 11.1 • n=270 Participants	46.2 years STANDARD_DEVIATION 11.5 • n=270 Participants	46.5 years STANDARD_DEVIATION 11.3 • n=540 Participants
Sex: Female, Male Female	174 Participants n=270 Participants	183 Participants n=270 Participants	357 Participants n=540 Participants
Sex: Female, Male Male	96 Participants n=270 Participants	87 Participants n=270 Participants	183 Participants n=540 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=270 Participants	0 Participants n=270 Participants	0 Participants n=540 Participants
Race (NIH/OMB) Asian	0 Participants n=270 Participants	0 Participants n=270 Participants	0 Participants n=540 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=270 Participants	0 Participants n=270 Participants	0 Participants n=540 Participants
Race (NIH/OMB) Black or African American	270 Participants n=270 Participants	270 Participants n=270 Participants	540 Participants n=540 Participants
Race (NIH/OMB) White	0 Participants n=270 Participants	0 Participants n=270 Participants	0 Participants n=540 Participants
Race (NIH/OMB) More than one race	0 Participants n=270 Participants	0 Participants n=270 Participants	0 Participants n=540 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=270 Participants	0 Participants n=270 Participants	0 Participants n=540 Participants
Region of Enrollment United States	270 participants n=270 Participants	270 participants n=270 Participants	540 participants n=540 Participants
Married or living with partner	91 Participants n=269 Participants • One participant refused the question.	75 Participants n=270 Participants • One participant refused the question.	166 Participants n=539 Participants • One participant refused the question.
Monthly family income <$1800	169 Participants n=267 Participants • 6 participants refused the question.	158 Participants n=267 Participants • 6 participants refused the question.	327 Participants n=534 Participants • 6 participants refused the question.
Education > or = high school	225 Participants n=269 Participants • One participant refused the question.	229 Participants n=270 Participants • One participant refused the question.	454 Participants n=539 Participants • One participant refused the question.
Weight	196.1 lbs STANDARD_DEVIATION 51.8 • n=270 Participants	194.8 lbs STANDARD_DEVIATION 54.0 • n=270 Participants	195.5 lbs STANDARD_DEVIATION 52.9 • n=540 Participants
BMI	31.1 kg/m 2 STANDARD_DEVIATION 7.6 • n=269 Participants • One participant refused to collect weight.	31.1 kg/m 2 STANDARD_DEVIATION 8.1 • n=270 Participants • One participant refused to collect weight.	31.1 kg/m 2 STANDARD_DEVIATION 7.9 • n=539 Participants • One participant refused to collect weight.
Depression(CESD-10) score	7.2 units on a scale STANDARD_DEVIATION 4.9 • n=269 Participants • One participant refused the questions.	8.2 units on a scale STANDARD_DEVIATION 5.5 • n=270 Participants • One participant refused the questions.	7.7 units on a scale STANDARD_DEVIATION 5.2 • n=539 Participants • One participant refused the questions.
Stress (PSS-4)	4.9 units on a scale STANDARD_DEVIATION 3.1 • n=269 Participants • One participant refused to answer.	5.5 units on a scale STANDARD_DEVIATION 3.3 • n=270 Participants • One participant refused to answer.	5.2 units on a scale STANDARD_DEVIATION 3.2 • n=539 Participants • One participant refused to answer.
Serum Cotinine	268.7 ng/ml STANDARD_DEVIATION 160.2 • n=269 Participants • 4 participants had samples that were unable to be analyzed.	283.0 ng/ml STANDARD_DEVIATION 151.2 • n=267 Participants • 4 participants had samples that were unable to be analyzed.	275.8 ng/ml STANDARD_DEVIATION 155.8 • n=536 Participants • 4 participants had samples that were unable to be analyzed.
Exhaled Carbon monoxide	15.8 ppm STANDARD_DEVIATION 9.4 • n=202 Participants • Exhaled carbon monoxide was added after the study began and was collected only on 411 of 540 participants.	17.1 ppm STANDARD_DEVIATION 10.5 • n=209 Participants • Exhaled carbon monoxide was added after the study began and was collected only on 411 of 540 participants.	16.4 ppm STANDARD_DEVIATION 10.0 • n=411 Participants • Exhaled carbon monoxide was added after the study began and was collected only on 411 of 540 participants.
Cigarettes per day	8.0 cigarettes per day STANDARD_DEVIATION 2.6 • n=270 Participants	7.9 cigarettes per day STANDARD_DEVIATION 2.4 • n=270 Participants	8.0 cigarettes per day STANDARD_DEVIATION 2.5 • n=540 Participants
Fagerstrom Test for Nicotine Dependence- 6 item	3.1 score STANDARD_DEVIATION 1.7 • n=270 Participants	3.3 score STANDARD_DEVIATION 1.7 • n=270 Participants	3.2 score STANDARD_DEVIATION 1.7 • n=540 Participants
Time to first cigarette,< or = 30 minutes	191 Participants n=270 Participants	199 Participants n=270 Participants	390 Participants n=540 Participants
Smoke Menthol Cigarettes	224 Participants n=270 Participants	228 Participants n=270 Participants	452 Participants n=540 Participants
Quit Attempts	3.5 Quit Attempts STANDARD_DEVIATION 7.9 • n=270 Participants	3.9 Quit Attempts STANDARD_DEVIATION 7.4 • n=270 Participants	3.7 Quit Attempts STANDARD_DEVIATION 7.7 • n=540 Participants
Pharmacotherapy use during most recent quit attempt	72 Participants n=270 Participants	61 Participants n=270 Participants	133 Participants n=540 Participants
Age of first cigarette	17.5 years STANDARD_DEVIATION 5.8 • n=270 Participants	18.1 years STANDARD_DEVIATION 7.3 • n=270 Participants	17.6 years STANDARD_DEVIATION 5.9 • n=540 Participants
Age started smoking regularly	21.1 years STANDARD_DEVIATION 6.7 • n=269 Participants • One participant declined to respond.	21.3 years STANDARD_DEVIATION 7.4 • n=270 Participants • One participant declined to respond.	21.1 years STANDARD_DEVIATION 7.1 • n=539 Participants • One participant declined to respond.
Motivation Scale	9.7 units on a scale STANDARD_DEVIATION 0.8 • n=270 Participants	9.8 units on a scale STANDARD_DEVIATION 0.7 • n=270 Participants	9.7 units on a scale STANDARD_DEVIATION 0.8 • n=540 Participants
Confidence Scale	7.9 units on a scale STANDARD_DEVIATION 2.1 • n=270 Participants	7.8 units on a scale STANDARD_DEVIATION 2.0 • n=270 Participants	7.9 units on a scale STANDARD_DEVIATION 2.4 • n=540 Participants
Smoke-free household	65 Participants n=270 Participants	67 Participants n=270 Participants	132 Participants n=540 Participants
California Tobacco Survey: Inhale deeply	65 Participants n=270 Participants	61 Participants n=270 Participants	126 Participants n=540 Participants