NCT00507728 is a Phase 2, PHASE3 clinical trial of Bupropion in Tobacco Use Disorder, sponsored by M.D. Anderson Cancer Center.

Who is sponsoring NCT00507728?

NCT00507728 is sponsored by M.D. Anderson Cancer Center.

What drugs are being tested in NCT00507728?

Interventions in NCT00507728: Bupropion, Varenicline, Placebo, Smoking Cessation Counseling.

What condition does NCT00507728 study?

NCT00507728 studies Tobacco Use Disorder, Smoking Cessation.

Is NCT00507728 still recruiting?

NCT00507728 is currently completed. Last updated 6 May 2021.

Are results published for NCT00507728?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-05-06 · How we verify

NCT00507728

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Pharmacogenetics, Emotional Reactivity and Smoking

Completed Phase 2, PHASE3 Results posted Last updated 6 May 2021

What this trial tests

Phase 2, PHASE3 trial testing Bupropion in Tobacco Use Disorder in 646 participants. Completed in 18 December 2019.

Timeline

8 December 2005

Primary endpoint
18 December 2019

18 December 2019

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	646
Start date	8 December 2005
Primary completion	18 December 2019
Estimated completion	18 December 2019
Sites	1 location across United States

Drugs / interventions tested

Bupropion (bupropion) — full drug profile →
Varenicline (varenicline) — full drug profile →
Placebo
Smoking Cessation Counseling

Conditions studied

Tobacco Use Disorder — all drugs for Tobacco Use Disorder →
Smoking Cessation — all drugs for Smoking Cessation →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

Adults 18 to 65, any sex, with Tobacco Use Disorder or Smoking Cessation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Emotional Reactivity By Pharmacotherapy Primary · Baseline to 1 month

Emotional reactivity measured by the peak eye blink electromyography (EMG) of the orbicularis oculi (ORB) muscle responses to acoustic startle probe delivered during the presentation of emotionally valent stimuli (pleasant, unpleasant, neutral, and smoking-related pictures). A single value was estimated by averaging within the specific time interval.

Emotional Reactivity (ORB) to Cigarette Stimuli

Group	Value	95% CI
Varenicline	66.6	62.3 – 71.1
Bupropion	64.7	60.9 – 68.5
Placebo	65.6	61.5 – 69.7

Emotional Reactivity (ORB) to Negative Stimuli

Group	Value	95% CI
Varenicline	70.9	66.4 – 75.4
Bupropion	73.1	69.2 – 76.9
Placebo	65.6	61.5 – 69.7

Emotional Reactivity (ORB) to Positive Stimuli

Group	Value	95% CI
Varenicline	66.7	62.5 – 70.9
Bupropion	65.4	61.8 – 68.9
Placebo	64.7	60.8 – 68.6

Emotional Reactivity (ORB) to Neutral Stimuli

Group	Value	95% CI
Varenicline	59.6	45.2 – 74.1
Bupropion	64.9	52.7 – 77.2
Placebo	72.5	59.3 – 85.7

Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele Primary · Baseline to 1 month

The emotional reactivity (ORB EMG) of smokers during cessation will be moderated by genotype. A single value was estimated by averaging within the specific time interval. During a quit attempt, smokers were evaluated on how they react to smoking related cues. An interaction term was then formed by the reactivity to smoking stimulus and genotype.

Emotional Reactivity (ORB) to Cigarette Stimuli

Group	Value	95% CI
Varenicline w/o DRD2 A1 Allele	66.5	61.1 – 71.9
Varenicline With DRD2 A1 Allele	69.9	62.8 – 77.0
Bupropion w/o DRD2 A1 Allele	66.2	60.4 – 72
Bupropion With DRD2 A1 Allele	66	60.9 – 71.2
Placebo w/o DRD2 A1 Allele	67.3	61.5 – 73.1
Placebo With DRD2 A1 Allele	68.1	62.2 – 73.9

Emotional Reactivity (ORB) to Negative Stimuli

Group	Value	95% CI
Varenicline w/o DRD2 A1 Allele	70.5	65 – 75.9
Varenicline With DRD2 A1 Allele	75.1	67.9 – 82.2
Bupropion w/o DRD2 A1 Allele	78.6	72.8 – 84.4
Bupropion With DRD2 A1 Allele	71.3	66.2 – 76.5
Placebo w/o DRD2 A1 Allele	74	68.2 – 79.7
Placebo With DRD2 A1 Allele	68.1	62.2 – 73.9

Emotional Reactivity (ORB) to Positive Stimuli

Group	Value	95% CI
Varenicline w/o DRD2 A1 Allele	65.5	60.4 – 70.6
Varenicline With DRD2 A1 Allele	72	65.3 – 78.7
Bupropion w/o DRD2 A1 Allele	71.3	65.8 – 76.7
Bupropion With DRD2 A1 Allele	63.3	58.4 – 681.
Placebo w/o DRD2 A1 Allele	68.5	63.1 – 74
Placebo With DRD2 A1 Allele	63.8	58.3 – 69.4

Emotional Reactivity (ORB) to Neutral Stimuli

Group	Value	95% CI
Varenicline w/o DRD2 A1 Allele	55.3	37.4 – 73.2
Varenicline With DRD2 A1 Allele	67.2	43 – 91.5
Bupropion w/o DRD2 A1 Allele	73.9	54.6 – 93.1
Bupropion With DRD2 A1 Allele	61.2	44 – 78.3
Placebo w/o DRD2 A1 Allele	79.7	61 – 98.5
Placebo With DRD2 A1 Allele	67.8	48.3 – 87.2

Smoking Abstinence at 3 Months Secondary · Baseline to 3 months

Values represent change in probability of abstinence for unit change in emotional reactivity. Abstinence data collected using a timeline follow-back (TLFB) procedure. Continuous Abstinence was defined as no smoking within the last 4 weeks of treatment. It is scored as 0 if the participant smoked during the specific interval, and 1 if the participant abstained from smoking.

Emotional Reactivity (ORB) to Cigarette Stimuli

Group	Value	95% CI
Varenicline	-0.003	-0.0777 – 0.072
Bupropion	-0.01	-0.084 – 0.065
Placebo	-0.008	-0.096 – 0.081

Emotional Reactivity (ORB) to Negative Stimuli

Group	Value	95% CI
Varenicline	-0.004	-0.081 – 0.073
Bupropion	-0.009	-0.076 – 0.058
Placebo	-0.007	-0.088 – 0.073

Emotional Reactivity (ORB) to Positive Stimuli

Group	Value	95% CI
Varenicline	-0.003	-0.081 – 0.076
Bupropion	-0.01	-0.084 – 0.064
Placebo	-0.007	-0.092 – 0.079

Emotional Reactivity (ORB) to Neutral Stimuli

Group	Value	95% CI
Varenicline	-0.004	-0.085 – 0.076
Bupropion	-0.008	-0.084 – 0.068
Placebo	-0.007	-0.088 – 0.075

Smoking Abstinence at 3 Months by DRD2 A1 Allele Secondary · Baseline to 3 Month

Emotional Reactivity (ORB) to Cigarette Stimuli

Group	Value	95% CI
Varenicline w/o DRD2 A1 Allele	0.001	-0.002 – 0.004
Varenicline With DRD2 A1 Allele	-0.004	-0.008 – 0
Bupropion w/o DRD2 A1 Allele	0	-0.003 – 0.003
Bupropion With DRD2 A1 Allele	-0.003	-0.006 – 0.001
Placebo w/o DRD2 A1 Allele	-0.001	-0.003 – 0.001
Placebo With DRD2 A1 Allele	-0.004	-0.008 – 0

Emotional Reactivity (ORB) to Negative Stimuli

Group	Value	95% CI
Varenicline w/o DRD2 A1 Allele	0.002	-0.002 – 0.005
Varenicline With DRD2 A1 Allele	-0.005	-0.008 – -0.001
Bupropion w/o DRD2 A1 Allele	0	-0.002 – 0.002
Bupropion With DRD2 A1 Allele	-0.004	-0.007 – 0.001
Placebo w/o DRD2 A1 Allele	-0.001	-0.003 – 0.001
Placebo With DRD2 A1 Allele	-0.004	-0.008 – 0

Emotional Reactivity (ORB) to Positive Stimuli

Group	Value	95% CI
Varenicline w/o DRD2 A1 Allele	0.001	-0.002 – 0.005
Varenicline With DRD2 A1 Allele	-0.005	-0.009 – -0.001
Bupropion w/o DRD2 A1 Allele	0	-0.003 – 0.002
Bupropion With DRD2 A1 Allele	-0.003	-0.006 – 0
Placebo w/o DRD2 A1 Allele	-0.001	-0.003 – 0.001
Placebo With DRD2 A1 Allele	-0.004	-0.007 – 0

Emotional Reactivity (ORB) to Neutral Stimuli

Group	Value	95% CI
Varenicline w/o DRD2 A1 Allele	0.001	-0.002 – 0.005
Varenicline With DRD2 A1 Allele	-0.005	-0.009 – -0.001
Bupropion w/o DRD2 A1 Allele	0.001	-0.002 – 0.003
Bupropion With DRD2 A1 Allele	-0.002	-0.005 – 0.001
Placebo w/o DRD2 A1 Allele	-0.001	-0.003 – 0.001
Placebo With DRD2 A1 Allele	-0.003	-0.007 – 0.001

Smoking Abstinence at 6 Months Secondary · Abstinence at 6 Months ( the effects shown are the increase/decrease in probability of abstinence for 1 unit increase in the predictor)

Emotional Reactivity (ORB) to Cigaretee Stimuli

Group	Value	95% CI
Varenicline	0.007	-0.067 – 0.082
Bupropion	-0.002	-0.073 – 0.069
Placebo	-0.006	-0.091 – 0.079

Emotional Reactivity (ORB) to Negative Stimuli

Group	Value	95% CI
Varenicline	0.008	-0.069 – 0.085
Bupropion	-0.003	-0.067 – 0.062
Placebo	-0.005	-0.081 – 0.071

Emotional Reactivity (ORB) to Positive Stimuli

Group	Value	95% CI
Varenicline	0.01	-0.065 – 0.086
Bupropion	-0.003	-0.075 – 0.068
Placebo	-0.005	-0.087 – 0.078

Emotional Reactivity (ORB) to Neutral Stimuli

Group	Value	95% CI
Varenicline	0.008	-0.071 – 0.087
Bupropion	-0.001	-0.078 – 0.076
Placebo	-0.005	-0.052 – 0.041

Abstinence at 6 Months by DRD2 A1 Allele Secondary · Baseline to 6 Month ( the effects shown are the increase/decrease in probability of abstinence for 1 unit increase in the predictor)

Emotional Reactivity (ORB) to Cigarette Stimuli

Group	Value	95% CI
Varenicline w/o DRD2 A1 Allele	0.003	0 – 0.005
Varenicline With DRD2 A1 Allele	-0.001	-0.005 – 0.003
Bupropion w/o DRD2 A1 Allele	0.001	-0.002 – 0.003
Bupropion With DRD2 A1 Allele	-0.001	-0.004 – 0.002
Placebo w/o DRD2 A1 Allele	0	-0.002 – 0.001
Placebo With DRD2 A1 Allele	-0.005	-0.01 – 0

Emotional Reactivity (ORB) to Negative Stimuli

Group	Value	95% CI
Varenicline w/o DRD2 A1 Allele	0.003	0.001 – 0.005
Varenicline With DRD2 A1 Allele	-0.001	-0.005 – 0.003
Bupropion w/o DRD2 A1 Allele	0.001	-0.001 – 0.003
Bupropion With DRD2 A1 Allele	-0.002	-0.005 – 0.001
Placebo w/o DRD2 A1 Allele	0	-0.002 – 0.001
Placebo With DRD2 A1 Allele	-0.004	-0.008 – 0

Emotional Reactivity (ORB) to Positive Stimuli

Group	Value	95% CI
Varenicline w/o DRD2 A1 Allele	0.003	0.001 – 0.006
Varenicline With DRD2 A1 Allele	0	-0.005 – 0.004
Bupropion w/o DRD2 A1 Allele	0	-0.002 – 0.003
Bupropion With DRD2 A1 Allele	-0.001	-0.004 – 0.002
Placebo w/o DRD2 A1 Allele	0	-0.002 – 0.002
Placebo With DRD2 A1 Allele	-0.004	-0.008 – 0

Emotional Reactivity (ORB) to Neutral Stimuli

Group	Value	95% CI
Varenicline w/o DRD2 A1 Allele	0.003	0 – 0.005
Varenicline With DRD2 A1 Allele	-0.001	-0.005 – 0.003
Bupropion w/o DRD2 A1 Allele	0.001	-0.002 – 0.004
Bupropion With DRD2 A1 Allele	-0.001	-0.004 – 0.002
Placebo w/o DRD2 A1 Allele	0	-0.002 – 0.001
Placebo With DRD2 A1 Allele	-0.004	-0.009 – 0

Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS) Secondary · Baseline to 8 months

Symptoms of nicotine withdrawal measured using Wisconsin Smoking Withdrawal Scale (WSWS). The Wisconsin Withdrawal Scale (WSWS) contains 7 factors: Anger, Anxiety, Sadness, Concentration, Craving, Sleep, and Hunger. WSWS consists of 28 items that are scored on a 5-point Likert type scale (0 = strongly disagree, 4 = strongly agree). A single value was estimated by averaging within the specific time interval. Higher values represent worse outcome. The average value was estimated from Baseline to 8 months

Anger

Group	Value	95% CI
Varenicline w/o DRD2 A1 Allele	4.394	3.629 – 5.159
Varenicline With DRD2 A1 Allele	4.222	3.152 – 5.291
Bupropion w/o DRD2 A1 Allele	4.28	3.402 – 5.157
Bupropion With DRD2 A1 Allele	4.41	3.59 – 5.23
Placebo w/o DRD2 A1 Allele	5.584	4.744 – 6.424
Placebo With DRD2 A1 Allele	5.752	4.884 – 6.621

Anxiety

Group	Value	95% CI
Varenicline w/o DRD2 A1 Allele	6.218	5.384 – 7.052
Varenicline With DRD2 A1 Allele	5.873	4.707 – 7.038
Bupropion w/o DRD2 A1 Allele	6.587	5.63 – 7.543
Bupropion With DRD2 A1 Allele	6.587	5.63 – 7.543
Placebo w/o DRD2 A1 Allele	7.785	6.87 – 8.7
Placebo With DRD2 A1 Allele	7.915	6.968 – 8.862

Concentration

Group	Value	95% CI
Varenicline w/o DRD2 A1 Allele	3.743	3.117 – 4.369
Varenicline With DRD2 A1 Allele	3.407	2.531 – 4.282
Bupropion w/o DRD2 A1 Allele	4.238	3.521 – 4.956
Bupropion With DRD2 A1 Allele	3.935	3.265 – 4.605
Placebo w/o DRD2 A1 Allele	4.764	4.077 – 5.451
Placebo With DRD2 A1 Allele	4.951	4.242 – 5.66

Craving

Group	Value	95% CI
Varenicline w/o DRD2 A1 Allele	6.646	5.591 – 7.701
Varenicline With DRD2 A1 Allele	6.252	4.777 – 7.726
Bupropion w/o DRD2 A1 Allele	6.814	5.605 – 8.024
Bupropion With DRD2 A1 Allele	6.78	5.651 – 7.91
Placebo w/o DRD2 A1 Allele	9.024	7.866 – 10.181
Placebo With DRD2 A1 Allele	8.696	7.499 – 9.893

Hunger

Group	Value	95% CI
Varenicline w/o DRD2 A1 Allele	11.016	10.09 – 11.942
Varenicline With DRD2 A1 Allele	10.707	9.413 – 12.001
Bupropion w/o DRD2 A1 Allele	9.79	8.729 – 10.852
Bupropion With DRD2 A1 Allele	11.082	10.09 – 12.074
Placebo w/o DRD2 A1 Allele	11.207	10.19 – 12.223
Placebo With DRD2 A1 Allele	11.044	9.994 – 12.095

Sadness

Group	Value	95% CI
Varenicline w/o DRD2 A1 Allele	4.246	3.535 – 4.958
Varenicline With DRD2 A1 Allele	3.738	2.744 – 4.732
Bupropion w/o DRD2 A1 Allele	4.005	3.189 – 4.82
Bupropion With DRD2 A1 Allele	4.338	3.577 – 5.1
Placebo w/o DRD2 A1 Allele	5.293	4.513 – 6.074
Placebo With DRD2 A1 Allele	5.865	5.057 – 6.673

Sleep

Group	Value	95% CI
Varenicline w/o DRD2 A1 Allele	7.721	6.494 – 8.948
Varenicline With DRD2 A1 Allele	8.153	6.438 – 9.868
Bupropion w/o DRD2 A1 Allele	9.672	8.265 – 11.079
Bupropion With DRD2 A1 Allele	9.528	8.214 – 10.843
Placebo w/o DRD2 A1 Allele	9.078	7.731 – 10.424
Placebo With DRD2 A1 Allele	8.629	7.236 – 10.023

Symptoms of Nicotine Withdrawal and Negative Affect Using Positive and Negative Affect Scale (PANAS) Secondary · Baseline to 8 months

Symptoms of nicotine withdrawal and negative affect were measured using the Positive and Negative Affect Scale (PANAS). The Positive and Negative Affect Schedule (PANAS) is a self-report questionnaire to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much). Scores can range from 10-50 for both the Positive and Negative Affect with the lower scores representing lower levels of Positive/Negative Affect and higher scores representing higher levels of Positive/Negative Affect. The average value was estimated from Baseline to 8 months

Positive Affect

Group	Value	95% CI
Varenicline w/o DRD2 A1 Allele	35.507	33.494 – 37.521
Varenicline With DRD2 A1 Allele	37.315	34.5 – 40.13
Bupropion w/o DRD2 A1 Allele	36.429	34.122 – 38.735
Bupropion With DRD2 A1 Allele	35.281	33.125 – 37.437
Placebo w/o DRD2 A1 Allele	33.672	31.463 – 35.882
Placebo With DRD2 A1 Allele	33.984	31.709 – 36.259

Negative Affect

Group	Value	95% CI
Varenicline w/o DRD2 A1 Allele	15.93	14.404 – 17.455
Varenicline With DRD2 A1 Allele	14.98	12.849 – 17.112
Bupropion w/o DRD2 A1 Allele	15.782	14.032 – 17.532
Bupropion With DRD2 A1 Allele	16.385	14.751 – 18.02
Placebo w/o DRD2 A1 Allele	18.017	16.343 – 19.691
Placebo With DRD2 A1 Allele	18.902	17.166 – 20.638

Symptoms of Depression Using the Center for Epidemiologic Studies Depression Scale (CES-D) Secondary · Baseline to 8 months

Symptoms of nicotine withdrawal measured using Center for Epidemiologic Studies Depression Scale (CES-D). Center of Epidemiologic Studies Depression Scale (CESD) a 20-item measure that asks caregivers to rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater de

Group	Value	95% CI
Varenicline w/o DRD2 A1 Allele	8.084	6.19 – 9.978
Varenicline With DRD2 A1 Allele	6.847	4.2 – 9.494
Bupropion w/o DRD2 A1 Allele	7.588	5.416 – 9.76
Bupropion With DRD2 A1 Allele	8.362	6.333 – 10.39
Placebo w/o DRD2 A1 Allele	8.65	6.572 – 10.729
Placebo With DRD2 A1 Allele	10.799	8.647 – 12.951

Measures of Smoking Satisfaction and Psychological Reward Using the Modified Cigarette Evaluation Questionnaire (mCEQ) Subscales Secondary · Baseline to 8 months

Modified Cigarette Evaluation Questionnaire (mCEQ). mCEQ Smoking satisfaction: range (1-21); mCEQ Psychological Reward: range(1-35); mCEQ Aversion: range (1-14); mCEQ Enjoyment of Resp.Tract Sens: range (1-7); mCEQ Craving Reduction: range (1-7). For all scales of mCEQ higher scores indicate worse outcomes (greater intensity of smoking effect). Scores of mCEQ Smoking satisfaction, mCEQ psychological reward and mCEQ aversion were summed to create the subscales. mCEQ Enjoyment of Resp Tract Sens and mCEQ Craving Reduction were single items.

Smoking Satisfaction

Group	Value	95% CI
Varenicline w/o DRD2 A1 Allele	2.895	1.912 – 3.879
Varenicline With DRD2 A1 Allele	2.591	1.253 – 3.93
Bupropion w/o DRD2 A1 Allele	4.064	2.94 – 5.187
Bupropion With DRD2 A1 Allele	3.369	2.135 – 4.603
Placebo w/o DRD2 A1 Allele	3.025	2.087 – 3.963
Placebo With DRD2 A1 Allele	3.515	2.368 – 4.662

Psychological Reward

Group	Value	95% CI
Varenicline w/o DRD2 A1 Allele	2.819	2.109 – 3.528
Varenicline With DRD2 A1 Allele	2.155	1.181 – 3.13
Bupropion w/o DRD2 A1 Allele	2.519	1.693 – 3.346
Bupropion With DRD2 A1 Allele	2.723	1.812 – 3.634
Placebo w/o DRD2 A1 Allele	3.575	2.861 – 4.289
Placebo With DRD2 A1 Allele	3.246	2.399 – 4.093

Aversion

Group	Value	95% CI
Varenicline w/o DRD2 A1 Allele	1.612	1.357 – 1.867
Varenicline With DRD2 A1 Allele	1.694	1.342 – 2.045
Bupropion w/o DRD2 A1 Allele	1.988	1.69 – 2.286
Bupropion With DRD2 A1 Allele	1.79	1.461 – 2.119
Placebo w/o DRD2 A1 Allele	1.808	1.549 – 2.067
Placebo With DRD2 A1 Allele	1.69	1.384 – 1.996

Enjoyment of Respiratory Tract Sensation

Group	Value	95% CI
Varenicline w/o DRD2 A1 Allele	1.912	0.146 – 3.678
Varenicline With DRD2 A1 Allele	1.703	-0.692 – 4.099
Bupropion w/o DRD2 A1 Allele	4.096	2.094 – 6.099
Bupropion With DRD2 A1 Allele	1.955	-0.243 – 4.153
Placebo w/o DRD2 A1 Allele	3.711	2.048 – 5.375
Placebo With DRD2 A1 Allele	2.783	0.741 – 4.825

Craving Reduction

Group	Value	95% CI
Varenicline w/o DRD2 A1 Allele	4.531	3.232 – 5.831
Varenicline With DRD2 A1 Allele	3.952	2.2 – 5.705
Bupropion w/o DRD2 A1 Allele	4.564	3.083 – 6.044
Bupropion With DRD2 A1 Allele	6.628	5.017 – 8.238
Placebo w/o DRD2 A1 Allele	4.486	3.269 – 5.702
Placebo With DRD2 A1 Allele	4.673	3.176 – 6.17

Skin Conductance Response Secondary · Baseline to 1 month

Skin conductance response (SCR) amplitude measured by placing an electrodermal response transducer on the fore and ring fingers of the participants non-dominant hand, and heart rate (HR) was collected by placing a photoelectric pulse plethysmogram transducer on the middle finger of the participants non-dominant hand, during the presentation of emotionally valent stimuli (positive, negative, neutral, and smoking-related pictures). A single value was estimated by averaging within the specific time interval.

Skin conductance to Cigarette Stimuli

Group	Value	95% CI
Varenicline w/o DRD2 A1 Allele	2.301	1.619 – 2.982
Varenicline With DRD2 A1 Allele	2.016	1.132 – 2.901
Bupropion w/o DRD2 A1 Allele	2.275	1.512 – 3.037
Bupropion With DRD2 A1 Allele	1.797	1.082 – 2.511
Placebo w/o DRD2 A1 Allele	2.272	1.54 – 3.005
Placebo With DRD2 A1 Allele	2.443	1.703 – 3.183

Skin conductance to Negative Stimuli

Group	Value	95% CI
Varenicline w/o DRD2 A1 Allele	2.295	1.613 – 2.976
Varenicline With DRD2 A1 Allele	1.969	1.084 – 2.855
Bupropion w/o DRD2 A1 Allele	2.31	1.547 – 3.072
Bupropion With DRD2 A1 Allele	1.695	0.999 – 2.391
Placebo w/o DRD2 A1 Allele	2.355	1.611 – 3.099
Placebo With DRD2 A1 Allele	2.485	1.756 – 3.215

Skin conductance to Positive Stimuli

Group	Value	95% CI
Varenicline w/o DRD2 A1 Allele	2.256	1.58 – 2.931
Varenicline With DRD2 A1 Allele	1.984	1.106 – 2.862
Bupropion w/o DRD2 A1 Allele	2.299	1.542 – 3.055
Bupropion With DRD2 A1 Allele	1.7	1.01 – 2.39
Placebo w/o DRD2 A1 Allele	2.296	1.569 – 3.023
Placebo With DRD2 A1 Allele	2.565	1.831 – 3.299

Skin conductance to Neutral Stimuli

Group	Value	95% CI
Varenicline w/o DRD2 A1 Allele	2.261	1.578 – 2.944
Varenicline With DRD2 A1 Allele	2.017	1.13 – 2.904
Bupropion w/o DRD2 A1 Allele	2.369	1.602 – 3.136
Bupropion With DRD2 A1 Allele	1.699	1.002 – 2.397
Placebo w/o DRD2 A1 Allele	2.362	1.616 – 3.107
Placebo With DRD2 A1 Allele	2.559	1.82 – 3.299

Heart Rate Response Secondary · Baseline to 1 month

Heart Rate Response. A single value was estimated by averaging within the specific time interval. During a quit attempt, smokers were evaluated on how they react to smoking related cues. An interaction term was then formed by the reactivity to smoking stimulus and genotype.

Heart Rate response to Cigarette Stimuli

Group	Value	95% CI
Varenicline w/o DRD2 A1 Allele	69.731	66.962 – 72.5
Varenicline With DRD2 A1 Allele	68.652	65.068 – 72.236
Bupropion w/o DRD2 A1 Allele	71.427	68.331 – 74.524
Bupropion With DRD2 A1 Allele	69.836	66.974 – 72.699
Placebo w/o DRD2 A1 Allele	65.966	62.987 – 68.944
Placebo With DRD2 A1 Allele	65.276	62.266 – 68.286

Heart Rate response to Negative Stimuli

Group	Value	95% CI
Varenicline w/o DRD2 A1 Allele	69.562	66.722 – 72.402
Varenicline With DRD2 A1 Allele	68.078	64.403 – 71.753
Bupropion w/o DRD2 A1 Allele	71.077	67.904 – 74.25
Bupropion With DRD2 A1 Allele	69.595	66.699 – 72.492
Placebo w/o DRD2 A1 Allele	65.768	62.713 – 68.823
Placebo With DRD2 A1 Allele	65.569	62.523 – 68.615

Heart Rate response to Positive Stimuli

Group	Value	95% CI
Varenicline w/o DRD2 A1 Allele	69.151	66.351 – 71.95
Varenicline With DRD2 A1 Allele	68.711	65.087 – 72.334
Bupropion w/o DRD2 A1 Allele	71.518	68.386 – 74.65
Bupropion With DRD2 A1 Allele	70.404	67.546 – 73.262
Placebo w/o DRD2 A1 Allele	65.787	62.776 – 68.799
Placebo With DRD2 A1 Allele	65.927	62.929 – 68.926

Heart Rate response to Neutral Stimuli

Group	Value	95% CI
Varenicline w/o DRD2 A1 Allele	69.621	66.798 – 72.444
Varenicline With DRD2 A1 Allele	68.969	65.315 – 72.624
Bupropion w/o DRD2 A1 Allele	71.706	68.546 – 74.865
Bupropion With DRD2 A1 Allele	70.234	67.351 – 73.117
Placebo w/o DRD2 A1 Allele	65.237	62.2 – 68.273
Placebo With DRD2 A1 Allele	66.04	62.981 – 69.098

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline, up to 8 months. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Varenicline

Serious: 2/75 (3%)

Deaths: 0/75

Bupropion

Serious: 2/89 (2%)

Deaths: 0/89

Placebo

Serious: 0/90 (0%)

Deaths: 0/90

Serious adverse events (6 terms)

Reaction	System	Varenicline	Bupropion	Placebo
Shortness of Breath	Respiratory, thoracic and mediastinal disorders	—	—	—
Dizziness	Nervous system disorders	—	—	—
Eczema	Skin and subcutaneous tissue disorders	—	—	—
Urinary Incontinence	Renal and urinary disorders	—	—	—
Chest pain - cardiac	Cardiac disorders	—	—	—
Increased Coughing	Respiratory, thoracic and mediastinal disorders	—	—	—

Other adverse events (82 terms — click to expand)

Reaction	System	Varenicline	Bupropion	Placebo
Insomnia	Nervous system disorders	—	—	—
Rhinitis	Respiratory, thoracic and mediastinal disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Irritability	Psychiatric disorders	—	—	—
Abnormal Dreams	Psychiatric disorders	—	—	—
Anxiety Symptoms	Psychiatric disorders	—	—	—
Headache	Nervous system disorders	—	—	—
Diarrhea	Gastrointestinal disorders	—	—	—
Disturbance in attention	Psychiatric disorders	—	—	—
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	—	—	—
Chest pain - cardiac	Cardiac disorders	—	—	—
Shortness of Breath	Respiratory, thoracic and mediastinal disorders	—	—	—
Depression	Psychiatric disorders	—	—	—
Fatigue	General disorders	—	—	—
Increased Coughing	Respiratory, thoracic and mediastinal disorders	—	—	—
Sore throat	Respiratory, thoracic and mediastinal disorders	—	—	—
APPETITE INCREASED	General disorders	—	—	—
Influenza	General disorders	—	—	—
Dry mouth	General disorders	—	—	—
Toothache	General disorders	—	—	—
Constipation	Gastrointestinal disorders	—	—	—
Eczema	Skin and subcutaneous tissue disorders	—	—	—
Gastritis	Gastrointestinal disorders	—	—	—
Infection	General disorders	—	—	—
Pain	General disorders	—	—	—
TASTE PERVERSION	General disorders	—	—	—
Drowsiness	Nervous system disorders	—	—	—
Edema	Musculoskeletal and connective tissue disorders	—	—	—
Restlessness	Psychiatric disorders	—	—	—
APPETITE DECREASED	General disorders	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—
Blurred vision	Eye disorders	—	—	—
Chest wall pain	Musculoskeletal and connective tissue disorders	—	—	—
Dizziness	General disorders	—	—	—
Emotional liability	Psychiatric disorders	—	—	—
Flatulence	Gastrointestinal disorders	—	—	—
Hypertension	Cardiac disorders	—	—	—
Tachycardia/Palpita..	Cardiac disorders	—	—	—
Urinary frequency	Renal and urinary disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—

Most-reported serious reactions: Shortness of Breath, Dizziness, Eczema, Urinary Incontinence, Chest pain - cardiac, Increased Coughing.

Data from ClinicalTrials.gov NCT00507728 adverse events section.

Sponsor's own description

The goals of this placebo-controlled randomized clinical trial were to evaluate the differences in emotional reactivity (peak startle response to affective stimuli) during a cessation attempt among smokers treated with bupropion, varenicline, or placebo, and to determine if these differences were moderated by genotype.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Smoking cessation for improving mental health.
Taylor GM, Lindson N, Farley A, Leinberger-Jabari A, et al · · 2021 · cited 160× · PMID 33687070 · DOI 10.1002/14651858.cd013522.pub2
Effects of varenicline and bupropion sustained-release use plus intensive smoking cessation counseling on prolonged abstinence from smoking and on depression, negative affect, and other symptoms of nicotine withdrawal.
Cinciripini PM, Robinson JD, Karam-Hage M, Minnix JA, et al · · 2013 · cited 105× · PMID 23536105 · DOI 10.1001/jamapsychiatry.2013.678
Benefits of varenicline vs. bupropion for smoking cessation: a Bayesian analysis of the interaction of reward sensitivity and treatment.
Cinciripini PM, Green CE, Robinson JD, Karam-Hage M, et al · · 2017 · cited 24× · PMID 28275830 · DOI 10.1007/s00213-017-4580-2
Do brain responses to emotional images and cigarette cues differ? An fMRI study in smokers.
Versace F, Engelmann JM, Jackson EF, Costa VD, et al · · 2011 · cited 24× · PMID 22097928 · DOI 10.1111/j.1460-9568.2011.07915.x
The CHRNA3 rs578776 Variant is Associated with an Intrinsic Reward Sensitivity Deficit in Smokers.
Robinson JD, Versace F, Lam CY, Minnix JA, et al · · 2013 · cited 19× · PMID 24065931 · DOI 10.3389/fpsyt.2013.00114
Reinforcement sensitivity underlying treatment-seeking smokers' affect, smoking reinforcement motives, and affective responses.
Cui Y, Robinson JD, Engelmann JM, Lam CY, et al · · 2015 · cited 5× · PMID 25621416 · DOI 10.1037/adb0000050
Pharmacological intervention and abstinence in smokers undergoing cessation treatment: A psychophysiological study.
Cui Y, Engelmann JM, Xian J, Minnix JA, et al · · 2018 · cited 4× · PMID 29223599 · DOI 10.1016/j.ijpsycho.2017.12.001
Deep sequencing of candidate genes identified 14 variants associated with smoking abstinence in an ethnically diverse sample.
Cinciripini PM, Wetter DW, Wang J, Yu R, et al · · 2024 · PMID 38493193 · DOI 10.1038/s41598-024-56750-7

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00507728 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
Last refreshed: 6 May 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00507728.

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NCT00507728

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (6 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Bupropion

Other recruiting trials for Tobacco Use Disorder

Other M.D. Anderson Cancer Center trials

Verify against primary sources