Nicotine DependenceNicExNCT01047930
The Effect of Exercise on Acute Nicotine Withdrawal
A study testing Exercise in people with Nicotine Dependence and Smoking, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence, Smoking, Sleep Disorders, Intrinsic
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jul 2013
- Phase
- Interventional
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center, Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, 15213
About this study
Official title: The Effect of Exercise on Acute Nicotine Withdrawal: Human Study
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.
Read the 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.
- Conditions
- Nicotine Dependence, Smoking, Sleep Disorders, Intrinsic
- Being tested
- Exercise
- 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
- Medical subject headings
- Tobacco Use Disorder, Smoking, Sleep Disorders, Intrinsic, Sleep Initiation and Maintenance Disorders, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| AM-Ex; PM-Ex; C | Other | within subject design, with each participant receiving all three conditions Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7/2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Isabella Soreca, University of Pittsburgh
- Investigators
- Isabella Soreca, M.D., Principal investigator, University of Pittsburgh Medical Center, Western Psychiatric Institute and Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01047930
- Sponsor's protocol ID
- PRO09060305
- Other IDs
- 1R01DA027508-01
- Acronym
- NicEx
- Status last verified
- Dec 2014
- First submitted
- 12 Jan 2010
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
al'Absi M, Amunrud T, Wittmers LE. Psychophysiological effects of nicotine abstinence and behavioral challenges in habitual smokers. Pharmacol Biochem Behav. 2002 Jun;72(3):707-16. doi: 10.1016/s0091-3057(02)00739-6.
PubMed 12175468American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, fourth edition. American Psychiatric Association, Washington, DC, 1994
Anton MM, Cortez-Cooper MY, DeVan AE, Neidre DB, Cook JN, Tanaka H. Resistance training increases basal limb blood flow and vascular conductance in aging humans. J Appl Physiol (1985). 2006 Nov;101(5):1351-5. doi: 10.1152/japplphysiol.00497.2006. Epub 2006 Jul 13.
PubMed 16840576Audrain-McGovern J, Rodriguez D, Moss HB. Smoking progression and physical activity. Cancer Epidemiol Biomarkers Prev. 2003 Nov;12(11 Pt 1):1121-9.
PubMed 14652270Benowitz NL. Neurobiology of nicotine addiction: implications for smoking cessation treatment. Am J Med. 2008 Apr;121(4 Suppl 1):S3-10. doi: 10.1016/j.amjmed.2008.01.015.
PubMed 18342164Biddle SJH, Fox KR, Boutcher SH (Eds): Physical activity and psychological well-being. Routledge, New York, NY, 2000.
Blakesley RE, Mazumdar S, Dew MA, Houck PR, Tang G, Reynolds CF 3rd, Butters MA. Comparisons of methods for multiple hypothesis testing in neuropsychological research. Neuropsychology. 2009 Mar;23(2):255-64. doi: 10.1037/a0012850.
PubMed 19254098Chen X, Wei L. A comparison of recent methods for the analysis of small-sample cross-over studies. Stat Med. 2003 Sep 30;22(18):2821-33. doi: 10.1002/sim.1537.
PubMed 12953282Ekkekakis P. Pleasure and displeasure from the body: Perspectives from exercise. Cogn Emot. 2003 Mar;17(2):213-239. doi: 10.1080/02699930302292.
PubMed 29715726Ekkekakis P, Hall EE, Petruzzello SJ. The relationship between exercise intensity and affective responses demystified: to crack the 40-year-old nut, replace the 40-year-old nutcracker! Ann Behav Med. 2008 Apr;35(2):136-49. doi: 10.1007/s12160-008-9025-z. Epub 2008 Mar 28.
PubMed 18369689Ekkekakis P, Hall EE, Petruzzello SJ. Variation and homogeneity in affective responses to physical activity of varying intensities: an alternative perspective on dose-response based on evolutionary considerations. J Sports Sci. 2005 May;23(5):477-500. doi: 10.1080/02640410400021492.
PubMed 16194996Fox KR. The influence of physical activity on mental well-being. Public Health Nutr. 1999 Sep;2(3A):411-8. doi: 10.1017/s1368980099000567.
PubMed 10610081Grove RJ, Wilkinson A, Dawson B, Eastwood P, Heard P: Effects of exercise on subjective aspects of sleep during tobacco withdrawal. Aust Psychol 41:69-76, 2006.
Hughes JR. Effects of abstinence from tobacco: valid symptoms and time course. Nicotine Tob Res. 2007 Mar;9(3):315-27. doi: 10.1080/14622200701188919.
PubMed 17365764Johnson RA, Wichern DW: Applied Multivariate Statistical Analysis, 5th edition. Prentice Hall, Upper Saddle River, NJ, 2002.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise on Acute Nicotine Withdrawal: Human Study
- ClinicalTrials.gov ID
- NCT01047930
- Acronym / sponsor ID
- NicEx / PRO09060305
- Conditions
- Nicotine Dependence, Smoking, Sleep Disorders, Intrinsic
- Keywords
- Insomnia, Smoking, Cue reactivity, Exercise timing, Acute nicotine withdrawal, Mood disturbances, Smoking abstinence, Exercise intensity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jan 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 13 Jan 2010 (estimated)
- 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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AM-Ex; PM-Ex; C | Other | Behavioral: Exercisewithin subject design, with each participant receiving all three conditions |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| ExerciseEach 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. | Behavioural | AM-Ex; PM-Ex; C |
Primary outcome
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
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 2 Dec 2014.
- Background: PubMed 12175468al'Absi M, Amunrud T, Wittmers LE. Psychophysiological effects of nicotine abstinence and behavioral challenges in habitual smokers. Pharmacol Biochem Behav. 2002 Jun;72(3):707-16. doi: 10.1016/s0091-3057(02)00739-6.
- BackgroundAmerican Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, fourth edition. American Psychiatric Association, Washington, DC, 1994
- Background: PubMed 16840576Anton MM, Cortez-Cooper MY, DeVan AE, Neidre DB, Cook JN, Tanaka H. Resistance training increases basal limb blood flow and vascular conductance in aging humans. J Appl Physiol (1985). 2006 Nov;101(5):1351-5. doi: 10.1152/japplphysiol.00497.2006. Epub 2006 Jul 13.
- Background: PubMed 14652270Audrain-McGovern J, Rodriguez D, Moss HB. Smoking progression and physical activity. Cancer Epidemiol Biomarkers Prev. 2003 Nov;12(11 Pt 1):1121-9.
- Background: PubMed 18342164Benowitz NL. Neurobiology of nicotine addiction: implications for smoking cessation treatment. Am J Med. 2008 Apr;121(4 Suppl 1):S3-10. doi: 10.1016/j.amjmed.2008.01.015.
- BackgroundBiddle SJH, Fox KR, Boutcher SH (Eds): Physical activity and psychological well-being. Routledge, New York, NY, 2000.
- Background: PubMed 19254098Blakesley RE, Mazumdar S, Dew MA, Houck PR, Tang G, Reynolds CF 3rd, Butters MA. Comparisons of methods for multiple hypothesis testing in neuropsychological research. Neuropsychology. 2009 Mar;23(2):255-64. doi: 10.1037/a0012850.
- Background: PubMed 12953282Chen X, Wei L. A comparison of recent methods for the analysis of small-sample cross-over studies. Stat Med. 2003 Sep 30;22(18):2821-33. doi: 10.1002/sim.1537.
- Background: PubMed 29715726Ekkekakis P. Pleasure and displeasure from the body: Perspectives from exercise. Cogn Emot. 2003 Mar;17(2):213-239. doi: 10.1080/02699930302292.
- Background: PubMed 18369689Ekkekakis P, Hall EE, Petruzzello SJ. The relationship between exercise intensity and affective responses demystified: to crack the 40-year-old nut, replace the 40-year-old nutcracker! Ann Behav Med. 2008 Apr;35(2):136-49. doi: 10.1007/s12160-008-9025-z. Epub 2008 Mar 28.
- Background: PubMed 16194996Ekkekakis P, Hall EE, Petruzzello SJ. Variation and homogeneity in affective responses to physical activity of varying intensities: an alternative perspective on dose-response based on evolutionary considerations. J Sports Sci. 2005 May;23(5):477-500. doi: 10.1080/02640410400021492.
- Background: PubMed 10610081Fox KR. The influence of physical activity on mental well-being. Public Health Nutr. 1999 Sep;2(3A):411-8. doi: 10.1017/s1368980099000567.
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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.
Isabella Soreca, M.D. principal investigator
University of Pittsburgh Medical Center, Western Psychiatric Institute and Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Nicotine Dependence and Smoking, run by University of Pittsburgh at 1 site in United States.
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 8 inclusion and 10 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 2 Dec 2014. 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 United States. 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.
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?
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). 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 NCT01047930, which also lists 31 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 2 Dec 2014; AzTrials last refreshed its copy on 6 Nov 2026.