Effects of Exercise and Nicotine on Cognition in Smokers

NCT03091699 | Completed Phase 3

• 1 other identifier: Exercise and Nicotine
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Keywords

Smoking; Nicotine; Exercise; Cognition

Outcome Measures

Primary Outcomes (2)

• Cognition (working memory) accuracy

  intervention effects on the 3-back task accuracy (percentage of correct responses)

  1 day

• Cognition (working memory) reaction time

  intervention effects on the 3-back task reaction time (milliseconds)

  1 day

Secondary Outcomes (2)

• Cognition (working memory) accuracy

  1 day

• Cognition (working memory) reaction time

  1 day

Study Arms (2)

Moderate intensity exercise

EXPERIMENTAL

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

Nicotine Inhalation

ACTIVE COMPARATOR

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

Interventions

Nicotine DRUG

Participants will be required to smoke a cigarette to completion in a 20 minute time frame.

Also known as: Cigarettes

Nicotine Inhalation

Moderate Intensity Exercise BEHAVIORAL

Participants will be required to perform 20 minutes of acute moderate intensity exercise (brisk walk) on a treadmill.

Moderate intensity exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

Western University

London, Ontario, N6G 1G9, Canada

Location

Related Publications (4)

• Heishman SJ, Kleykamp BA, Singleton EG. Meta-analysis of the acute effects of nicotine and smoking on human performance. Psychopharmacology (Berl). 2010 Jul;210(4):453-69. doi: 10.1007/s00213-010-1848-1. Epub 2010 Apr 24.

  PMID: 20414766 BACKGROUND

• Hughes JR. Effects of abstinence from tobacco: etiology, animal models, epidemiology, and significance: a subjective review. Nicotine Tob Res. 2007 Mar;9(3):329-39. doi: 10.1080/14622200701188927.

  PMID: 17365765 BACKGROUND

• Jonides J, Schumacher EH, Smith EE, Lauber EJ, Awh E, Minoshima S, Koeppe RA. Verbal Working Memory Load Affects Regional Brain Activation as Measured by PET. J Cogn Neurosci. 1997 Jul;9(4):462-75. doi: 10.1162/jocn.1997.9.4.462.

  PMID: 23968211 BACKGROUND

• Stolz D, Scherr A, Seiffert B, Kuster M, Meyer A, Fagerstrom KO, Tamm M. Predictors of success for smoking cessation at the workplace: a longitudinal study. Respiration. 2014;87(1):18-25. doi: 10.1159/000346646. Epub 2013 Apr 10.

  PMID: 23594795 BACKGROUND

MeSH Terms

Conditions

Smoking Cessation; Smoking; Motor Activity

Interventions

Nicotine; Tobacco Products

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Harry Prapavessis, PhD

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor/Director of the Exercise Health and Psychology Lab

Model Details: Sequential two stage trial. Stage 1 will utilize a within-counterbalanced approach while stage 2 will utilize a randomized trial.

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: March 27, 2017
• Study Start: May 1, 2017
• Primary Completion: April 1, 2018
• Study Completion: May 1, 2024
• Last Updated: May 3, 2024

Record last verified: 2024-05

Locations

CA (1)