The Effect of Exercise on Acute Nicotine Withdrawal (NicEx)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by University of Pittsburgh.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Isabella Soreca, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01047930
First received: January 12, 2010
Last updated: May 1, 2012
Last verified: May 2012
  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: 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 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: January 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01047930

Contacts
Contact: Ronald Salkeld, BS 412-246-5953 salkeldrp@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center, Western Psychiatric Institute and Clinic Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Ronald Salkeld, BS    412-246-5953    salkeldrp@upmc.edu   
Sub-Investigator: David J. Kupfer, M.D.         
Sub-Investigator: Timothy Monk, Ph.D.         
Sub-Investigator: Yu Cheng, Ph.D.         
Sub-Investigator: Martica Hall, Ph.D.         
Sub-Investigator: John M. Jakicic, Ph.D.         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Isabella Soreca, M.D. University of Pittsburgh Medical Center, Western Psychiatric Institute and Clinic
  More Information

Publications:
Absi M, Amunrud T, Wittmers LE: Psychophysiological effects of nicotine abstinence and behavioral challenges in habitual smokers. Pharmacol Biochem Behav 72:707-716, 2002.
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 101:1351-1355, 2006.
Audrain-McGovern J, Rodriguez D, Moss HB: Smoking progression and physical activity. Cancer Epidemiol Biomarkers Prev 12:1121-1129, 2003.
Benowitz NL: Neurobiology of nicotine addiction: Implications for smoking cessation treatment. Am J Med 121:S3-S10, 2008.
Chen X, Wei L: A comparison of recent methods for the analysis of small-sample cross-over studies. Stat Med 22:2821-2833, 2003.
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 35:136-149, 2008.
Fox KR: The influence of physical activity on mental well-being. Public Health Nutr 2:411-418, 1999.
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.
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 300:1077-1079, 2008.
Nides MA: Predictors of initial smoking cessation and relapse through the first 2 years of the Lung Health Study. J Consult Clin Psychol 63:60-69, 1995.
Ortega FB, Ruiz JR, Castillo MJ, Sjöström M: Physical fitness in childhood and adolescence: A powerful marker of health. Int J Obes (Lond) 32:1-11, 2008.
Paavola M, Vartianen E, Puska P: Smoking cessation between teenage years and adulthood. Health Educ Res 16:49-57, 2001.
Piasecki TM, Niaura R, Shadel WG, Abrams D, Goldstein M, Fioore MC, Baker TB: Smoking withdrawal dynamics in unaided quitters. J Abnorm Psychol 109:74-86, 2000.
Taylor AH, Katomeri M, Ussher M: Acute effects of self-paced walking on urges to smoke during temporary smoking abstinence. Psychopharmacology (Berl) 181:1-7, 2005.
Taylor AH, Katomeri M: Effects of a brisk walk on blood pressure response to the Stroop, speech task and smoking cue among temporarily abstinent smokers. Psychopharmaclogy 184:247-253, 2006.
Taylor AH, Ussher MH, Faulkner G: The acute effects of exercise on cigarette cravings, withdrawal symptoms, affect and smoking behaviour: A systematic review. Addiction 102:534-543, 2007.
Hughes JR: Tobacco withdrawal in self quitters. J Consult Clin Psychol 60:689-697, 1992.

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
Study First Received: January 12, 2010
Last Updated: May 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by 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 Disorders
Parasomnias
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
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014