drugset / Trial / NCT00507728
Pharmacogenetics, Emotional Reactivity and Smoking
Phase 2/3
Completed
646 enrolled
M.D. Anderson Cancer Center
National Institute on Drug Abuse (NIDA) · collabNational Institutes of Health (NIH) · collab
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2005-12-08
- Primary completion
- 2019-12-18
- Completion
- 2019-12-18
Publications
- Background Cui Y, Robinson JD, Versace F, Lam CY, Minnix JA, Karam-Hage M, Dani JA, Kosten TR, Wetter DW, Brown VL, Cinciripini PM. Differential cigarette-related startle cue reactivity among light, moderate, and heavy smokers. Addict Behav. 2012 Aug;37(8):885-9. doi: 10.1016/j.addbeh.2012.02.003. Epub 2012 Feb 15.
- Background Cui Y, Versace F, Engelmann JM, Minnix JA, Robinson JD, Lam CY, Karam-Hage M, Brown VL, Wetter DW, Dani JA, Kosten TR, Cinciripini PM. Alpha oscillations in response to affective and cigarette-related stimuli in smokers. Nicotine Tob Res. 2013 May;15(5):917-24. doi: 10.1093/ntr/nts209. Epub 2012 Oct 11.
- Background Cui Y, Robinson JD, Engelmann JM, Lam CY, Minnix JA, Karam-Hage M, Wetter DW, Dani JA, Kosten TR, Cinciripini PM. Reinforcement sensitivity underlying treatment-seeking smokers' affect, smoking reinforcement motives, and affective responses. Psychol Addict Behav. 2015 Jun;29(2):300-311. doi: 10.1037/adb0000050. Epub 2015 Jan 26.
- Background Cui Y, Engelmann JM, Xian J, Minnix JA, Lam CY, Karam-Hage M, Cinciripini PM, Robinson JD. Pharmacological intervention and abstinence in smokers undergoing cessation treatment: A psychophysiological study. Int J Psychophysiol. 2018 Jan;123:25-34. doi: 10.1016/j.ijpsycho.2017.12.001. Epub 2017 Dec 6.
- Background Minnix JA, Versace F, Robinson JD, Lam CY, Engelmann JM, Cui Y, Brown VL, Cinciripini PM. The late positive potential (LPP) in response to varying types of emotional and cigarette stimuli in smokers: a content comparison. Int J Psychophysiol. 2013 Jul;89(1):18-25. doi: 10.1016/j.ijpsycho.2013.04.019. Epub 2013 May 2.
- Background Robinson JD, Versace F, Lam CY, Minnix JA, Engelmann JM, Cui Y, Karam-Hage M, Shete SS, Tomlinson GE, Chen TT, Wetter DW, Green CE, Cinciripini PM. The CHRNA3 rs578776 Variant is Associated with an Intrinsic Reward Sensitivity Deficit in Smokers. Front Psychiatry. 2013 Sep 23;4:114. doi: 10.3389/fpsyt.2013.00114. eCollection 2013.
- Background Versace F, Minnix JA, Robinson JD, Lam CY, Brown VL, Cinciripini PM. Brain reactivity to emotional, neutral and cigarette-related stimuli in smokers. Addict Biol. 2011 Apr;16(2):296-307. doi: 10.1111/j.1369-1600.2010.00273.x. Epub 2010 Dec 23.
- Background Versace F, Lam CY, Engelmann JM, Robinson JD, Minnix JA, Brown VL, Cinciripini PM. Beyond cue reactivity: blunted brain responses to pleasant stimuli predict long-term smoking abstinence. Addict Biol. 2012 Nov;17(6):991-1000. doi: 10.1111/j.1369-1600.2011.00372.x. Epub 2011 Oct 4.
- Background Versace F, Engelmann JM, Robinson JD, Jackson EF, Green CE, Lam CY, Minnix JA, Karam-Hage MA, Brown VL, Wetter DW, Cinciripini PM. Prequit fMRI responses to pleasant cues and cigarette-related cues predict smoking cessation outcome. Nicotine Tob Res. 2014 Jun;16(6):697-708. doi: 10.1093/ntr/ntt214. Epub 2013 Dec 27.
- Background Meyer MJ, Coull BA, Versace F, Cinciripini P, Morris JS. Bayesian function-on-function regression for multilevel functional data. Biometrics. 2015 Sep;71(3):563-74. doi: 10.1111/biom.12299. Epub 2015 Mar 18.
- Background Zhu H, Versace F, Cinciripini PM, Rausch P, Morris JS. Robust and Gaussian spatial functional regression models for analysis of event-related potentials. Neuroimage. 2018 Nov 1;181:501-512. doi: 10.1016/j.neuroimage.2018.07.006. Epub 2018 Jul 6.
- Background Cinciripini PM, Green CE, Robinson JD, Karam-Hage M, Engelmann JM, Minnix JA, Wetter DW, Versace F. Benefits of varenicline vs. bupropion for smoking cessation: a Bayesian analysis of the interaction of reward sensitivity and treatment. Psychopharmacology (Berl). 2017 Jun;234(11):1769-1779. doi: 10.1007/s00213-017-4580-2. Epub 2017 Mar 8.
- 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.
- Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
- Cinciripini PM, Robinson JD, Karam-Hage M, Minnix JA, Lam C, Versace F, Brown VL, Engelmann JM, Wetter DW. 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. JAMA Psychiatry. 2013 May;70(5):522-33. doi: 10.1001/jamapsychiatry.2013.678.
- Versace F, Engelmann JM, Jackson EF, Costa VD, Robinson JD, Lam CY, Minnix JA, Brown VL, Wetter DW, Cinciripini PM. Do brain responses to emotional images and cigarette cues differ? An fMRI study in smokers. Eur J Neurosci. 2011 Dec;34(12):2054-63. doi: 10.1111/j.1460-9568.2011.07915.x. Epub 2011 Nov 20.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bupropion | Small molecule | 150 mg | Oral |
| Subject | Varenicline | Small molecule | 1 mg | Oral |