NicEx: The Effect of Exercise on Acute Nicotine Withdrawal

Sponsor

University of Pittsburgh (Other)

Overall Status

Completed

CT.gov ID

NCT01047930

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

Enrollment

Location

Arm

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nicotine Dependence Smoking Sleep Disorders, Intrinsic	Behavioral: Exercise	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

88 participants

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

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Jul 1, 2013

Actual Study Completion Date :

Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Other: 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: Morning exercise - subject will exercise on each of the three mornings in the sleep laboratory, starting 30 minutes after their habitual rise-time; Evening exercise - subject will start exercise 4 hours before their habitual bedtime on each of the three evenings; No exercise - subject will watch television or read and they will be required to remain sedentary.

Arm

Intervention/Treatment

Other: 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: Morning exercise - subject will exercise on each of the three mornings in the sleep laboratory, starting 30 minutes after their habitual rise-time; Evening exercise - subject will start exercise 4 hours before their habitual bedtime on each of the three evenings; No exercise - subject will watch television or read and they will be required to remain sedentary.

Outcome Measures

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. [7/2013]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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