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Effects of Exercise and Nicotine on Cognition in Smokers

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ClinicalTrials.gov Identifier: NCT03091699
Recruitment Status : Unknown
Verified May 2017 by Dr. Harry Prapavessis, Western University, Canada.
Recruitment status was:  Recruiting
First Posted : March 27, 2017
Last Update Posted : May 12, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Harry Prapavessis, Western University, Canada

Brief Summary:
Adult smokers will participate in a two stage testing trial, where the first stage will utilize a within-subject counterbalance design and individuals will participate in both conditions. The second stage will utilize a two-arm randomized control trail. The two conditions are (a) moderate intensity exercise and (b) nicotine inhalation. The primary measure of assessment will be reaction time and accuracy on the N-back task.

Condition or disease Intervention/treatment Phase
Smoking Cessation Drug: Nicotine Behavioral: Moderate Intensity Exercise Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Sequential two stage trial. Stage 1 will utilize a within-counterbalanced approach while stage 2 will utilize a randomized trial.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Acute Effects of Moderate Intensity Exercise and Nicotine on Cognition in Smokers
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Moderate intensity exercise
The Exercise intervention will persist of a 20-minute bout of moderate intensity aerobic exercise which by definition is 40-65% of Maximum Heart Rate. Exercise consisted of a 2-minute warm-up, followed by 15 min of walking at a rate, which will allow you to reach 2/3 of your max heart rate, and then a 3-minute cool down on a treadmill equaling 20 minutes. Heart Rate will be examined with Polar Wearlink coded Heart Rate monitors to attain the specific exercise intensity.
Behavioral: Moderate Intensity Exercise
Participants will be required to perform 20 minutes of acute moderate intensity exercise (brisk walk) on a treadmill.

Active Comparator: Nicotine Inhalation
The nicotine inhalation group will smoke a cigarette to completion of their choice, in the 20 minute time period allocated in the Exercise and Health Psychology Lab psychological assessment room (the room will be equipped with windows that allow for ventilation and an air purifier. During this time the participant will refrain from conversation.
Drug: Nicotine
Participants will be required to smoke a cigarette to completion in a 20 minute time frame.
Other Name: Cigarettes




Primary Outcome Measures :
  1. Cognition (working memory) accuracy [ Time Frame: 1 day ]
    intervention effects on the 3-back task accuracy (percentage of correct responses)

  2. Cognition (working memory) reaction time [ Time Frame: 1 day ]
    intervention effects on the 3-back task reaction time (milliseconds)


Secondary Outcome Measures :
  1. Cognition (working memory) accuracy [ Time Frame: 1 day ]
    intervention effects on the 0,1,2-back task and accuracy (percentage of correct responses)

  2. Cognition (working memory) reaction time [ Time Frame: 1 day ]
    intervention effects on the 0,1,2-back task and accuracy (percentage of correct responses)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Fit the criteria of a smoker (smoke more than 5 cigarettes a day and on baseline assessment blow greater than 10 P.P.M. analyzed with the piCO+ Smokerlyzer.
  • At least 18 years old
  • Physically able to perform exercise
  • Read and write in English
  • Must have an email or telephone for communication

Exclusion Criteria:

  • COPD or inhaler dependent
  • Recent health issues such as a heart attack
  • Participants taking prescription medication for depression or asthma
  • Pregnant
  • Unable to give informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091699


Contacts
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Contact: Harry Prapavessis, PhD 5196612111 ext 80173 hprapave@uwo.ca

Locations
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Canada, Ontario
Western University Recruiting
London, Ontario, Canada, N6G 1G9
Contact: Harry Prapavessis, PhD    5196612111 ext 80173    hprapave@uwo.ca   
Principal Investigator: Harry Prapavessis, PhD         
Sub-Investigator: Matthew Fagan, B.A.         
Sponsors and Collaborators
Western University, Canada
Investigators
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Principal Investigator: Harry Prapavessis, PhD Professor

Publications:
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Responsible Party: Dr. Harry Prapavessis, Professor/Director of the Exercise Health and Psychology Lab, Western University, Canada
ClinicalTrials.gov Identifier: NCT03091699     History of Changes
Other Study ID Numbers: Exercise and Nicotine
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: May 12, 2017
Last Verified: May 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Dr. Harry Prapavessis, Western University, Canada:
Smoking
Nicotine
Exercise
Cognition
Additional relevant MeSH terms:
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Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action