Smoking Clinical Trial
— NicExOfficial title:
The Effect of Exercise on Acute Nicotine Withdrawal: Human Study
Verified date | December 2014 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The primary aim of this project is to test the effect of exercise on acute nicotine withdrawal. Acute nicotine withdrawal is characterized by a complex array of symptoms associated with increased risk of relapse among individuals attempting smoking cessation. The available remedies do not target all aspects of withdrawal. For example, pharmacologic treatments reduce withdrawal-based craving, but have no effect on cue-related craving, altered sleep, and mood disturbances during withdrawal. Therefore, non-pharmacologic behavioral techniques with the potential to attenuate persistent withdrawal symptoms are needed. We hypothesized that exercise can be a valid non-pharmacologic strategy to improve these domains.
Status | Completed |
Enrollment | 88 |
Est. completion date | July 2013 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Age 18-45 - Not regularly exercising, defined as exercising fewer than three times per week and for no more than 20 minutes each time - Free of medical illnesses (need to be cleared by a physician as able to exercise at 60% maximum heart rate (MHR)) - Currently meeting DSM-IV criteria for nicotine dependence (No Current or Past history of any other psychiatric disorder) - Regularly smoking at least 08 cigarettes per day for at least 12 consecutive months, not attempted to quit smoking in the previous month, and not currently taking medication for smoking cessation - Currently displaying carbon monoxide breath readings >10 and urine cotinine levels >3 - Habitual bedtime between 9:30 p.m. and 1:30 a.m. - Body Mass Index (BMI) less than 40. Exclusion Criteria: - Unable to exercise - Currently diagnosed or treated for any psychiatric disorder; treatment with psychotropic medication will be considered on a case by case basis - History or active treatment or any treatment in past year for any mood or psychotic disorder - Current or past diagnosis of a sleep disorder - Currently taking sleep medications or other medications known to alter sleep architecture - Currently doing shift work or working at night - History of travel across time zones in the past month - For women of child bearing potential: pregnant or actively trying to become pregnant - Parent of a child under two years of age - Diagnosis of Sleep Apnea |
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh Medical Center, Western Psychiatric Institute and Clinic | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh | National Institute on Drug Abuse (NIDA) |
United States,
al'Absi M, Amunrud T, Wittmers LE. Psychophysiological effects of nicotine abstinence and behavioral challenges in habitual smokers. Pharmacol Biochem Behav. 2002 Jun;72(3):707-16. — View Citation
American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, fourth edition. American Psychiatric Association, Washington, DC, 1994
Anton MM, Cortez-Cooper MY, DeVan AE, Neidre DB, Cook JN, Tanaka H. Resistance training increases basal limb blood flow and vascular conductance in aging humans. J Appl Physiol (1985). 2006 Nov;101(5):1351-5. Epub 2006 Jul 13. — View Citation
Audrain-McGovern J, Rodriguez D, Moss HB. Smoking progression and physical activity. Cancer Epidemiol Biomarkers Prev. 2003 Nov;12(11 Pt 1):1121-9. — View Citation
Benowitz NL. Neurobiology of nicotine addiction: implications for smoking cessation treatment. Am J Med. 2008 Apr;121(4 Suppl 1):S3-10. doi: 10.1016/j.amjmed.2008.01.015. Review. — View Citation
Biddle SJH, Fox KR, Boutcher SH (Eds): Physical activity and psychological well-being. Routledge, New York, NY, 2000.
Blakesley RE, Mazumdar S, Dew MA, Houck PR, Tang G, Reynolds CF 3rd, Butters MA. Comparisons of methods for multiple hypothesis testing in neuropsychological research. Neuropsychology. 2009 Mar;23(2):255-64. doi: 10.1037/a0012850. — View Citation
Chen X, Wei L. A comparison of recent methods for the analysis of small-sample cross-over studies. Stat Med. 2003 Sep 30;22(18):2821-33. — View Citation
Ekkekakis P, Hall EE, Petruzzello SJ. The relationship between exercise intensity and affective responses demystified: to crack the 40-year-old nut, replace the 40-year-old nutcracker! Ann Behav Med. 2008 Apr;35(2):136-49. doi: 10.1007/s12160-008-9025-z. Epub 2008 Mar 28. — View Citation
Ekkekakis P, Hall EE, Petruzzello SJ. Variation and homogeneity in affective responses to physical activity of varying intensities: an alternative perspective on dose-response based on evolutionary considerations. J Sports Sci. 2005 May;23(5):477-500. Review. — View Citation
Ekkekkais P: Pleasure and displeasure from the body: Perspective from exercise. Cogn Emot 17:213-239, 2003.
Fox KR. The influence of physical activity on mental well-being. Public Health Nutr. 1999 Sep;2(3A):411-8. Review. — View Citation
Grove RJ, Wilkinson A, Dawson B, Eastwood P, Heard P: Effects of exercise on subjective aspects of sleep during tobacco withdrawal. Aust Psychol 41:69-76, 2006.
Hughes JR. Effects of abstinence from tobacco: valid symptoms and time course. Nicotine Tob Res. 2007 Mar;9(3):315-27. Review. — View Citation
Hughes JR. Tobacco withdrawal in self-quitters. J Consult Clin Psychol. 1992 Oct;60(5):689-97. — View Citation
Johnson RA, Wichern DW: Applied Multivariate Statistical Analysis, 5th edition. Prentice Hall, Upper Saddle River, NJ, 2002.
Kenny PJ, Markou A. Neurobiology of the nicotine withdrawal syndrome. Pharmacol Biochem Behav. 2001 Dec;70(4):531-49. Review. — View Citation
Lautenschlager NT, Cox KL, Flicker L, Foster JK, van Bockxmeer FM, Xiao J, Greenop KR, Almeida OP. Effect of physical activity on cognitive function in older adults at risk for Alzheimer disease: a randomized trial. JAMA. 2008 Sep 3;300(9):1027-37. doi: 10.1001/jama.300.9.1027. Erratum in: JAMA. 2009 Jan 21;301(3):276. — View Citation
Netz Y, Zach S, Taffe JR, Guthrie J, Dennerstein L. Habitual physical activity is a meaningful predictor of well-being in mid-life women: a longitudinal analysis. Climacteric. 2008 Aug;11(4):337-44. doi: 10.1080/13697130802239083. — View Citation
Nides MA, Rakos RF, Gonzales D, Murray RP, Tashkin DP, Bjornson-Benson WM, Lindgren P, Connett JE. Predictors of initial smoking cessation and relapse through the first 2 years of the Lung Health Study. J Consult Clin Psychol. 1995 Feb;63(1):60-9. — View Citation
Ortega FB, Ruiz JR, Castillo MJ, Sjöström M. Physical fitness in childhood and adolescence: a powerful marker of health. Int J Obes (Lond). 2008 Jan;32(1):1-11. Epub 2007 Dec 4. Review. — View Citation
Paavola M, Vartiainen E, Puska P. Smoking cessation between teenage years and adulthood. Health Educ Res. 2001 Feb;16(1):49-57. — View Citation
Piasecki TM, Fiore MC, Baker TB. Profiles in discouragement: two studies of variability in the time course of smoking withdrawal symptoms. J Abnorm Psychol. 1998 May;107(2):238-51. — View Citation
Piasecki TM, Niaura R, Shadel WG, Abrams D, Goldstein M, Fiore MC, Baker TB. Smoking withdrawal dynamics in unaided quitters. J Abnorm Psychol. 2000 Feb;109(1):74-86. — View Citation
Taylor A, Katomeri M. Effects of a brisk walk on blood pressure responses to the Stroop, a speech task and a smoking cue among temporarily abstinent smokers. Psychopharmacology (Berl). 2006 Jan;184(2):247-53. Epub 2005 Dec 16. — View Citation
Taylor AH, Katomeri M, Ussher M. Acute effects of self-paced walking on urges to smoke during temporary smoking abstinence. Psychopharmacology (Berl). 2005 Aug;181(1):1-7. Epub 2005 Oct 15. — View Citation
Taylor AH, Ussher MH, Faulkner G. The acute effects of exercise on cigarette cravings, withdrawal symptoms, affect and smoking behaviour: a systematic review. Addiction. 2007 Apr;102(4):534-43. Review. — View Citation
US Department of Health and Human Services: Treating Tobacco Use and Dependence: 2008 Update. A report of the Surgeon General. Public Health Service, Rockville, MD, 2008.
Vanderkaay MM, Patterson SM. Nicotine and acute stress: effects of nicotine versus nicotine withdrawal on stress-induced hemoconcentration and cardiovascular reactivity. Biol Psychol. 2006 Feb;71(2):191-201. Epub 2005 Sep 21. — View Citation
Waters AJ, Shiffman S, Sayette MA, Paty JA, Gwaltney CJ, Balabanis MH. Cue-provoked craving and nicotine replacement therapy in smoking cessation. J Consult Clin Psychol. 2004 Dec;72(6):1136-43. — View Citation
Williams MA, Haskell WL, Ades PA, Amsterdam EA, Bittner V, Franklin BA, Gulanick M, Laing ST, Stewart KJ; American Heart Association Council on Clinical Cardiology; American Heart Association Council on Nutrition, Physical Activity, and Metabolism. Resistance exercise in individuals with and without cardiovascular disease: 2007 update: a scientific statement from the American Heart Association Council on Clinical Cardiology and Council on Nutrition, Physical Activity, and Metabolism. Circulation. 2007 Jul 31;116(5):572-84. Epub 2007 Jul 16. Review. — View Citation
* Note: There are 31 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary variables of interest are self-rating score of mood, objective measures of sleep latency and WASO, subjective ratings of craving, and cardiovascular reactivity including blood pressure and heart rate reactivity during cue reactivity. | 7/2013 | No |
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