Phase 3
Completed N=254
Pharmacogenetics, Emotional Reactivity and Smoking
Source: ClinicalTrials.gov NCT00507728 ↗Enrolled (actual)
254
Serious AEs
1.6%
Results posted
May 2021
Primary outcomePrimary: Emotional Reactivity By Pharmacotherapy — 66.6; 64.7; 65.6; 70.9 microvolts
◆ Published Evidence
Highly cited
136citations · ~10 / year
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.
Summary
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.
Linked Publications (4)
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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.
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Antidepressants for smoking cessation.
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Nicotine receptor partial agonists for smoking cessation.
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Do brain responses to emotional images and cigarette cues differ? An fMRI study in smokers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Emotional Reactivity By Pharmacotherapy |
66.6; 64.7; 65.6; 70.9; 73.1; 65.6 | — |
| PRIMARY Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele |
66.5; 69.9; 66.2; 66; 67.3; 68.1 | — |
| SECONDARY Smoking Abstinence at 3 Months |
-0.003; -0.01; -0.008; -0.004; -0.009; -0.007 | — |
| SECONDARY Smoking Abstinence at 3 Months by DRD2 A1 Allele |
0.001; -0.004; 0; -0.003; -0.001; -0.004 | — |
| SECONDARY Smoking Abstinence at 6 Months |
0.007; -0.002; -0.006; 0.008; -0.003; -0.005 | — |
| SECONDARY Abstinence at 6 Months by DRD2 A1 Allele |
0.003; -0.001; 0.001; -0.001; 0; -0.005 | — |
| SECONDARY Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS) |
4.394; 4.222; 4.28; 4.41; 5.584; 5.752 | — |
| SECONDARY Symptoms of Nicotine Withdrawal and Negative Affect Using Positive and Negative Affect Scale (PANAS) |
35.507; 37.315; 36.429; 35.281; 33.672; 33.984 | — |
| SECONDARY Symptoms of Depression Using the Center for Epidemiologic Studies Depression Scale (CES-D) |
8.084; 6.847; 7.588; 8.362; 8.65; 10.799 | — |
| SECONDARY Measures of Smoking Satisfaction and Psychological Reward Using the Modified Cigarette Evaluation Questionnaire (mCEQ) Subscales |
2.895; 2.591; 4.064; 3.369; 3.025; 3.515 | — |
| SECONDARY Skin Conductance Response |
2.301; 2.016; 2.275; 1.797; 2.272; 2.443 | — |
| SECONDARY Heart Rate Response |
69.731; 68.652; 71.427; 69.836; 65.966; 65.276 | — |
Eligibility Criteria
Inclusion Criteria
- Age: 18-65 years old
- Smoking: >/= 5 cigarettes per day within the 2 months preceding the screening visit and expired CO greater than or equal to 6 ppm.
- Able to follow verbal and written instructions in English and complete all aspects of the study
- Have an address and home telephone number where they may be reached
- Provide informed consent and agree to all assessments and study procedures
- Be the only participant in their household
Exclusion Criteria
- Within the month immediately preceding the screening visit; use of any form of tobacco product other than cigarettes on 3 or more days within a week only if the individual refuses to refrain from non-cigarette tobacco use during the course of this study
- Within the month immediately preceding the screening visit; use of marijuana in any form on 3 or more days within a week
- Within the two weeks immediately preceding the screening visit, involvement on more than 3 days in any formal smoking cessation activities
- Current visual or auditory problems that in the opinion of the investigator would interfere with the completion of study assessments
- Treatment on a continuous basis within 2 weeks before the screening visit: any contraindicated medication for Varenicline or Bupropion.
- Uncontrolled hypertension or other major contraindications for Bupropion or Varenicline.
- Severe renal impairment (CR Clearance <30 ml/min/1.73 m2).
- Laboratory evaluations outside normal limits and of potential clinical significance in the opinion of the investigator
- Meet current criteria for psychiatric disorders or substance abuse as assessed by the MINI for items A, B, D, I, J, K, L, M and N, including a past manic or hypomanic episode as well as a lifetime psychotic disorder.
- Subject rated as moderate to high on suicidality as assessed by the MINI.
- Psychiatric hospitalization within 1 year of screening date.
- A positive urine pregnancy test during the screening period. Women who are two years post menopausal, one year post-tubal ligation, or who have had a partial or full hysterectomy will not be subject to a urine pregnancy test.
- Pregnant, breast-feeding, or of childbearing potential who is not protected by a medically acceptable, effective method of birth control while enrolled in the study
- Use of Varenicline or Bupropion within two weeks before the screening visit.
- History of hypersensitivity or allergic reaction to Varenicline, tricyclic antidepressant, Bupropion (Wellbutrin, Zyban) or similar chemical classes or any component of these formulations.
- Subject considered by the investigator as unsuitable candidate for receipt of an investigational drug, or unstable to be followed up throughout the entire duration of the study.
Data sourced from ClinicalTrials.gov (NCT00507728) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.