The Effect of Exercise on Acute Nicotine Withdrawal (NicEx)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Isabella Soreca, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01047930
First received: January 12, 2010
Last updated: December 1, 2014
Last verified: December 2014
  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 ]

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

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

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
Investigators
Principal Investigator: Isabella Soreca, M.D. University of Pittsburgh Medical Center, Western Psychiatric Institute and Clinic
  More Information

Publications:
American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, fourth edition. American Psychiatric Association, Washington, DC, 1994
Biddle SJH, Fox KR, Boutcher SH (Eds): Physical activity and psychological well-being. Routledge, New York, NY, 2000.
Ekkekkais P: Pleasure and displeasure from the body: Perspective from exercise. Cogn Emot 17:213-239, 2003.
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.
Johnson RA, Wichern DW: Applied Multivariate Statistical Analysis, 5th edition. Prentice Hall, Upper Saddle River, NJ, 2002.
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.

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: December 1, 2014
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:
Parasomnias
Sleep Disorders
Sleep Disorders, Intrinsic
Substance Withdrawal Syndrome
Chemically-Induced Disorders
Dyssomnias
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Substance-Related Disorders
Nicotine
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 02, 2015