View Clinical Trial (Medical Research Study)
The Effect of Exercise on Acute Nicotine Withdrawal: Human Study
| City: |
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Pittsburgh |
| State: |
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Pennsylvania |
| Zip Code: |
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15213 |
| Conditions: |
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Nicotine Dependence - Smoking - Sleep Disorders, Intrinsic |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT01047930 |
| Primary Contact: |
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Principal Investigator
Isabella Soreca, M.D.
University of Pittsburgh Medical Center, Western Psychiatric Institute and Clinic
Ronald Salkeld, BS
Phone: 412-246-5953
Email: salkeldrp@upmc.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Pittsburgh, Pennsylvania 15213
United States
Ronald Salkeld, BS
Phone: 412-246-5953
Email: salkeldrp@upmc.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 18, 2013 |
| Modifications to this listing: |
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