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The Effect of Exercise on Acute Nicotine Withdrawal (NicEx)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01047930
First Posted: January 13, 2010
Last Update Posted: December 2, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Isabella Soreca, University of Pittsburgh
  Purpose
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.

Condition Intervention
Nicotine Dependence Smoking Sleep Disorders, Intrinsic Behavioral: Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effect of Exercise on Acute Nicotine Withdrawal: Human Study

Resource links provided by NLM:


Further study details as provided by Isabella Soreca, University of Pittsburgh:

Primary Outcome Measures:
  • 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. [ Time Frame: 7/2013 ]

Enrollment: 88
Study Start Date: January 2010
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
AM-Ex; PM-Ex; C
within subject design, with each participant receiving all three conditions
Behavioral: 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.

Detailed Description:
The goal of the proposed work is to test: 1) the effects of exercise on mood, objective measures of sleep, and cue reactivity; 2) the effects of exercise at a given intensity and duration, after a short (few hours) and more prolonged (24 to 72 hours) abstinence from smoking; and 3) the effects of exercising in the morning versus exercising in the evening on the proposed outcome domains. We plan to implement a within-subject design that will allow us to collect measures for each subject aged 18 to 45 in four different conditions: 1) ad libitum smoking; 2) evening exercise after 2 to 72 hours of abstinence; 3) morning exercise after 2 to 72 hours of abstinence; and 4) no exercise after 2 to 72 hours of abstinence. Exercise will be conducted at a fixed and monitored dose and duration. By collecting morning and evening measures of withdrawal symptoms and cue reactivity, we will also test whether the effects of exercise in reducing withdrawal symptoms and cue reactivity will show a prolonged effect beyond the minutes/hours immediately after the exercise bout. We also hypothesize that the timing of exercise may have differential effects on different aspect of withdrawal. The proposed work will allow us to examine the extent to which exercise, a promising nonpharmacologic behavioral treatment method, can attenuate key symptoms of withdrawal recognized to impede abstinence efforts. A better understanding of these effects will allow us to implement exercise at the time of day that may be more troublesome for the individual attempting to quit. The development of new behavioral methods for attenuating withdrawal symptoms will be directly transferable to smoking cessation treatments aimed at reducing withdrawal symptoms and aiding efforts to avoid relapse after quitting smoking.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01047930


Locations
United States, Pennsylvania
University of Pittsburgh Medical Center, Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Isabella Soreca, M.D. University of Pittsburgh Medical Center, Western Psychiatric Institute and Clinic
  More Information

Publications:
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.
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.
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. Review.
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.
Ekkekkais P: Pleasure and displeasure from the body: Perspective from exercise. Cogn Emot 17:213-239, 2003.
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. Review.
Fox KR. The influence of physical activity on mental well-being. Public Health Nutr. 1999 Sep;2(3A):411-8. Review.
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.
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.
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.
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.
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.
Paavola M, Vartiainen E, Puska P. Smoking cessation between teenage years and adulthood. Health Educ Res. 2001 Feb;16(1):49-57.
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.
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.
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.
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.
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.
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.
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.
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.
Hughes JR. Tobacco withdrawal in self-quitters. J Consult Clin Psychol. 1992 Oct;60(5):689-97.

Responsible Party: Isabella Soreca, Assistant Professor of Psychiatry, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01047930     History of Changes
Other Study ID Numbers: PRO09060305
1R01DA027508-01 ( U.S. NIH Grant/Contract )
First Submitted: January 12, 2010
First Posted: January 13, 2010
Last Update Posted: December 2, 2014
Last Verified: December 2014

Keywords provided by Isabella Soreca, University of Pittsburgh:
Insomnia
Smoking
Cue reactivity
Exercise timing
Acute nicotine withdrawal
Mood disturbances
Smoking abstinence
Exercise intensity
Altered sleep
Exercise duration
Nonpharmacologic behavioral treatment
Smoking cessation
Exercise Test
Polysomnography

Additional relevant MeSH terms:
Sleep Wake Disorders
Parasomnias
Tobacco Use Disorder
Substance Withdrawal Syndrome
Sleep Disorders, Intrinsic
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Dyssomnias
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action


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