The Effect of Exercise on Acute Nicotine Withdrawal

NCT01047930 | Completed DMC

• 2 other identifiers: PRO090603051R01DA027508-01
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

AM-Ex; PM-Ex; C

OTHER

within subject design, with each participant receiving all three conditions

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

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.

AM-Ex; PM-Ex; C

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Pittsburgh Medical Center, Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (31)

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MeSH Terms

Conditions

Tobacco Use Disorder; Smoking; Sleep Disorders, Intrinsic; Sleep Initiation and Maintenance Disorders; Smoking Cessation

Interventions

Exercise

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Health Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Isabella Soreca, M.D.

  University of Pittsburgh Medical Center, Western Psychiatric Institute and Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: January 12, 2010
• First Posted: January 13, 2010
• Study Start: January 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: December 2, 2014

Record last verified: 2014-12

Locations

US (1)