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The Effect of Exercise on Acute Nicotine Withdrawal (NicEx)

Primary Purpose

Nicotine Dependence, Smoking, Sleep Disorders, Intrinsic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Nicotine Dependence focused on measuring 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

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Pittsburgh Medical Center, Western Psychiatric Institute and Clinic

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

AM-Ex; PM-Ex; C

Arm Description

within subject design, with each participant receiving all three conditions

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
January 12, 2010
Last Updated
December 1, 2014
Sponsor
University of Pittsburgh
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01047930
Brief Title
The Effect of Exercise on Acute Nicotine Withdrawal
Acronym
NicEx
Official Title
The Effect of Exercise on Acute Nicotine Withdrawal: Human Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AM-Ex; PM-Ex; C
Arm Type
Other
Arm Description
within subject design, with each participant receiving all three conditions
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabella Soreca, M.D.
Organizational Affiliation
University of Pittsburgh Medical Center, Western Psychiatric Institute and Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Medical Center, Western Psychiatric Institute and Clinic
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

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The Effect of Exercise on Acute Nicotine Withdrawal

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