Clinical trial NCT01047930: The Effect of Exercise on Acute Nicotine Withdrawal
Official title: The Effect of Exercise on Acute Nicotine Withdrawal: Human Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nicotine Dependence
Smoking
Sleep Disorders, Intrinsic
Keywords: 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
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2010-01-13
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

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 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

Primary outcomes:
measure: 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.
timeFrame: 7/2013
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center, Western Psychiatric Institute and Clinic
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh Medical Center, Western Psychiatric Institute and Clinic
name: Isabella Soreca, M.D.
role: PRINCIPAL_INVESTIGATOR
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