Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
88 participants
INTERVENTIONAL
2010-01-31
2013-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
AM-Ex; PM-Ex; C
within subject design, with each participant receiving all three conditions
Exercise
Each 3-day experimental period will include one of the following conditions:
1. Morning exercise - subject will exercise on each of the three mornings in the sleep laboratory, starting 30 minutes after their habitual rise-time;
2. Evening exercise - subject will start exercise 4 hours before their habitual bedtime on each of the three evenings;
3. No exercise - subject will watch television or read and they will be required to remain sedentary.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Exercise
Each 3-day experimental period will include one of the following conditions:
1. Morning exercise - subject will exercise on each of the three mornings in the sleep laboratory, starting 30 minutes after their habitual rise-time;
2. Evening exercise - subject will start exercise 4 hours before their habitual bedtime on each of the three evenings;
3. No exercise - subject will watch television or read and they will be required to remain sedentary.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
45 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute on Drug Abuse (NIDA)
NIH
University of Pittsburgh
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Isabella Soreca
Assistant Professor of Psychiatry
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Isabella Soreca, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh Medical Center, Western Psychiatric Institute and Clinic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Pittsburgh Medical Center, Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Hughes JR. Effects of abstinence from tobacco: valid symptoms and time course. Nicotine Tob Res. 2007 Mar;9(3):315-27. doi: 10.1080/14622200701188919.
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. doi: 10.1016/s0091-3057(01)00651-7.
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.
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.
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. doi: 10.1037//0022-006x.63.1.60.
Ortega FB, Ruiz JR, Castillo MJ, Sjostrom M. Physical fitness in childhood and adolescence: a powerful marker of health. Int J Obes (Lond). 2008 Jan;32(1):1-11. doi: 10.1038/sj.ijo.0803774. Epub 2007 Dec 4.
Paavola M, Vartiainen E, Puska P. Smoking cessation between teenage years and adulthood. Health Educ Res. 2001 Feb;16(1):49-57. doi: 10.1093/her/16.1.49.
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. doi: 10.1037//0021-843x.107.2.238.
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. doi: 10.1037//0021-843x.109.1.74.
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. doi: 10.1007/s00213-005-2216-4. Epub 2005 Oct 15.
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. doi: 10.1007/s00213-005-0275-1. Epub 2005 Dec 16.
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. doi: 10.1111/j.1360-0443.2006.01739.x.
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. doi: 10.1016/j.biopsycho.2005.04.006. Epub 2005 Sep 21.
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. doi: 10.1037/0022-006X.72.6.1136.
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. doi: 10.1016/s0091-3057(02)00739-6.
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. doi: 10.1152/japplphysiol.00497.2006. Epub 2006 Jul 13.
Audrain-McGovern J, Rodriguez D, Moss HB. Smoking progression and physical activity. Cancer Epidemiol Biomarkers Prev. 2003 Nov;12(11 Pt 1):1121-9.
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.
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.
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. doi: 10.1002/sim.1537.
Ekkekakis P. Pleasure and displeasure from the body: Perspectives from exercise. Cogn Emot. 2003 Mar;17(2):213-239. doi: 10.1080/02699930302292.
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.
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. doi: 10.1080/02640410400021492.
Fox KR. The influence of physical activity on mental well-being. Public Health Nutr. 1999 Sep;2(3A):411-8. doi: 10.1017/s1368980099000567.
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.
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. doi: 10.1161/CIRCULATIONAHA.107.185214. Epub 2007 Jul 16.
Hughes JR. Tobacco withdrawal in self-quitters. J Consult Clin Psychol. 1992 Oct;60(5):689-97. doi: 10.1037//0022-006x.60.5.689.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PRO09060305
Identifier Type: -
Identifier Source: org_study_id