Smoking CessationPhase 3NCT03091699
Effects of Exercise and Nicotine on Cognition in Smokers
A Phase 3 study testing Nicotine and Moderate Intensity Exercise in people with Smoking Cessation, run by Western University, Canada at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Nicotine and Moderate Intensity Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2017to 1 May 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Acute Effects of Moderate Intensity Exercise and Nicotine on Cognition in Smokers
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.
Read the detailed description
The burden of smoking tobacco on the Canadian public is well-documented. Typically, two thirds of Canadian smokers will consider a quit attempt over the next six months. When an individual who is addicted to nicotine stops administering the psycho-stimulate cognitive deficits and tobacco cravings arise and are at the forefront of an unsuccessful quit attempt. Studies have shown that smoking or nicotine administration enhances alerting and orienting attention, short-term episodic memory, and working memory in smokers who were deprived or minimally deprived of nicotine. Moderate intensity exercise has been shown to increase many cognitive functions of the brain in non-smokers. Moderate intensity exercise also has been shown to increase cognition more than nicotine in a non-smoking population. Research regarding the effects of moderate exercise on cognition of non- deprived, as well as nicotine- deprived smokers is unknown.
The study will begin in April of 2017. The main purpose of this project is to examine if exercise could be a pragmatic alternative to smoking in cognitive deficits that arise during a quit attempt.
Thirsty four adult smokers will follow the protocol listed below:
Stage I will utilize a within subjects counter-balanced design. Previous to arrival for phase I participants will be asked to keep consumption of coffee to half a cup the day of testing, abstain from alcohol and drugs for at least 18 hours prior to testing, and smoke a cigarette of choice 30 minutes prior to arrival (for standardization). Participants will be urged to arrive at the same time for each visit. Upon arrival to the Exercise and Health Psychology lab (located in room 408 of the Arthur and Sonia Labatt Health Science Building at Western University) participants will be verified as smokers (based on the reading from the piCO+ Smokerlyzer being greater than 10 P.P.M.), given the letter of information and sign the informed consent form. Participants will also be asked to complete a demographic survey, smoking history questionnaire, PAR-Q readiness for exercise, Godin Leisure-Time Exercise Questionnaire, Fagerstrom Test for Nicotine Dependence, and pre nicotine or pre exercise questionnaire. Vitals (heart rate and blood pressure) will be assessed following the completion of the questionnaires as well as post intervention in the seated position. Prior to evaluation on the N-back task (cognitive memory task described below) a practice stage with be conducted until the participant can consistently score 75% or higher on three consecutive trials to eliminate a learning effect. After establishing familiarity a baseline cognition score will be conducted. The subject will then be given a 5 minute break (i.e., to use the lavatory). Following the break the participants will be randomized into either the exercise or nicotine inhalation group. The interventions are as followed; Moderate Intensity Exercise will persist of a 20-minute bout of moderate intensity aerobic exercise. 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. The Nicotine inhalation group will smoke a cigarette to completion of their choice, in the 20 minute time period allocated. During this time the participant will refrain from conversation. The post intervention assessment will begin within two minutes of the completion of either intervention. The second visit of phase I will take place the following day at the same time (if possible). During the second visit the participant's will complete the pre nicotine or pre exercise questionnaire and vitals will be monitored pre and post intervention. The participants will participate in the intervention that they have not received on the first visit (for example, if the participant received nicotine inhalation on the first visit the participant will receive moderate intensity aerobic exercise on the second visit). Within two minutes of completion the post treatment N-back task assessment will begin. Previous to arrival for stage II participants will be asked to keep consumption of coffee to half a cup the day of testing, abstain from alcohol and drugs for at least 18 hours prior to testing, and to abstain from smoking for at least 12 hours (overnight abstinence). Stage II will utilize the same participants as phase I but they will be examined in a nicotine-deprived state (12 hours) for baseline N-back scores and then randomized into nicotine inhalation group or exercise treatment group where post intervention N-back scores will be obtained. Pre nicotine or pre exercise questionnaire will be completed and vitals (heart rate and blood pressure) will be assessed pre and post intervention. Smoking abstinence will be validated with the piCO+ Smokerlyzer reading being less than 10 P.P.M.
This study will (a) provide information about the cognition of non-deprived smokers and nicotine deprived smokers (b) demonstrate if moderate intensity exercise would be a pragmatic alternative to nicotine for replenishing working memory deficits in these populations (c) add to the literature on moderate intensity exercise being a valid aid for smokers attempting a real quit attempt (d) assist in the development of new cessation programs involving exercise.
- Conditions
- Smoking Cessation
- Being tested
- Nicotine, Moderate Intensity Exercise
- Keywords
- Smoking, Nicotine, Exercise, Cognition
- Medical subject headings
- Smoking Cessation, Smoking, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicotineDrug
Also called Cigarettes
Participants will be required to smoke a cigarette to completion in a 20 minute time frame.
Moderate Intensity ExerciseBehavioural
Participants will be required to perform 20 minutes of acute moderate intensity exercise (brisk walk) on a treadmill.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Nicotine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognition (working memory) accuracy
intervention effects on the 3-back task accuracy (percentage of correct responses)
Measured: 1 day
Cognition (working memory) reaction time
intervention effects on the 3-back task reaction time (milliseconds)
Measured: 1 day
Secondary outcomes (2)
Cognition (working memory) accuracy
intervention effects on the 0,1,2-back task and accuracy (percentage of correct responses)
Measured: 1 day
Cognition (working memory) reaction time
intervention effects on the 0,1,2-back task and accuracy (percentage of correct responses)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start1 May 2017
- Primary completion1 Apr 2018
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Harry Prapavessis, Western University, Canada
- Investigators
- Harry Prapavessis, PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03091699
- Sponsor's protocol ID
- Exercise and Nicotine
- Status last verified
- May 2024
- First submitted
- 15 Mar 2017
- Last updated
- 3 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 20414766Hughes 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.
PubMed 17365765Jonides 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.
PubMed 23968211Stolz 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.
PubMed 23594795
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effects of Moderate Intensity Exercise and Nicotine on Cognition in Smokers
- ClinicalTrials.gov ID
- NCT03091699
- Acronym / sponsor ID
- Exercise and Nicotine
- Conditions
- Smoking Cessation
- Keywords
- Smoking, Nicotine, Exercise, Cognition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 27 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The burden of smoking tobacco on the Canadian public is well-documented. Typically, two thirds of Canadian smokers will consider a quit attempt over the next six months. When an individual who is addicted to nicotine stops administering the psycho-stimulate cognitive deficits and tobacco cravings arise and are at the forefront of an unsuccessful quit attempt. Studies have shown that smoking or nicotine administration enhances alerting and orienting attention, short-term episodic memory, and working memory in smokers who were deprived or minimally deprived of nicotine. Moderate intensity exercise has been shown to increase many cognitive functions of the brain in non-smokers. Moderate intensity exercise also has been shown to increase cognition more than nicotine in a non-smoking population. Research regarding the effects of moderate exercise on cognition of non- deprived, as well as nicotine- deprived smokers is unknown.
The study will begin in April of 2017. The main purpose of this project is to examine if exercise could be a pragmatic alternative to smoking in cognitive deficits that arise during a quit attempt.
Thirsty four adult smokers will follow the protocol listed below:
Stage I will utilize a within subjects counter-balanced design. Previous to arrival for phase I participants will be asked to keep consumption of coffee to half a cup the day of testing, abstain from alcohol and drugs for at least 18 hours prior to testing, and smoke a cigarette of choice 30 minutes prior to arrival (for standardization). Participants will be urged to arrive at the same time for each visit. Upon arrival to the Exercise and Health Psychology lab (located in room 408 of the Arthur and Sonia Labatt Health Science Building at Western University) participants will be verified as smokers (based on the reading from the piCO+ Smokerlyzer being greater than 10 P.P.M.), given the letter of information and sign the informed consent form. Participants will also be asked to complete a demographic survey, smoking history questionnaire, PAR-Q readiness for exercise, Godin Leisure-Time Exercise Questionnaire, Fagerstrom Test for Nicotine Dependence, and pre nicotine or pre exercise questionnaire. Vitals (heart rate and blood pressure) will be assessed following the completion of the questionnaires as well as post intervention in the seated position. Prior to evaluation on the N-back task (cognitive memory task described below) a practice stage with be conducted until the participant can consistently score 75% or higher on three consecutive trials to eliminate a learning effect. After establishing familiarity a baseline cognition score will be conducted. The subject will then be given a 5 minute break (i.e., to use the lavatory). Following the break the participants will be randomized into either the exercise or nicotine inhalation group. The interventions are as followed; Moderate Intensity Exercise will persist of a 20-minute bout of moderate intensity aerobic exercise. 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. The Nicotine inhalation group will smoke a cigarette to completion of their choice, in the 20 minute time period allocated. During this time the participant will refrain from conversation. The post intervention assessment will begin within two minutes of the completion of either intervention. The second visit of phase I will take place the following day at the same time (if possible). During the second visit the participant's will complete the pre nicotine or pre exercise questionnaire and vitals will be monitored pre and post intervention. The participants will participate in the intervention that they have not received on the first visit (for example, if the participant received nicotine inhalation on the first visit the participant will receive moderate intensity aerobic exercise on the second visit). Within two minutes of completion the post treatment N-back task assessment will begin. Previous to arrival for stage II participants will be asked to keep consumption of coffee to half a cup the day of testing, abstain from alcohol and drugs for at least 18 hours prior to testing, and to abstain from smoking for at least 12 hours (overnight abstinence). Stage II will utilize the same participants as phase I but they will be examined in a nicotine-deprived state (12 hours) for baseline N-back scores and then randomized into nicotine inhalation group or exercise treatment group where post intervention N-back scores will be obtained. Pre nicotine or pre exercise questionnaire will be completed and vitals (heart rate and blood pressure) will be assessed pre and post intervention. Smoking abstinence will be validated with the piCO+ Smokerlyzer reading being less than 10 P.P.M.
This study will (a) provide information about the cognition of non-deprived smokers and nicotine deprived smokers (b) demonstrate if moderate intensity exercise would be a pragmatic alternative to nicotine for replenishing working memory deficits in these populations (c) add to the literature on moderate intensity exercise being a valid aid for smokers attempting a real quit attempt (d) assist in the development of new cessation programs involving exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Sequential two stage trial. Stage 1 will utilize a within-counterbalanced approach while stage 2 will utilize a randomized trial.
| Arm | Type | Receives |
|---|---|---|
| Moderate intensity exercise | Experimental | Behavioral: Moderate Intensity ExerciseThe 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. |
| Nicotine Inhalation | Active comparator | Drug: NicotineThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NicotineAlso: CigarettesParticipants will be required to smoke a cigarette to completion in a 20 minute time frame. | Drug | Nicotine Inhalation |
| Moderate Intensity ExerciseParticipants will be required to perform 20 minutes of acute moderate intensity exercise (brisk walk) on a treadmill. | Behavioural | Moderate intensity exercise |
Primary outcome
Cognition (working memory) accuracy
Time frame: 1 day
intervention effects on the 3-back task accuracy (percentage of correct responses)
Cognition (working memory) reaction time
Time frame: 1 day
intervention effects on the 3-back task reaction time (milliseconds)
2 secondary outcomes
Cognition (working memory) accuracy
Time frame: 1 day
Cognition (working memory) reaction time
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Background: PubMed 20414766Heishman 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.
- Background: PubMed 17365765Hughes 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.
- Background: PubMed 23968211Jonides 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.
- Background: PubMed 23594795Stolz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harry Prapavessis, PhD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nicotine and Moderate Intensity Exercise in people with Smoking Cessation, run by Western University, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognition (working memory) accuracy (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03091699, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.