Nicotine DependencePhase 2NCT00713063
Behavioral Exercise Intervention for Smoking Cessation
A Phase 2 study testing aerobic exercise in people with Nicotine Dependence, run by Butler Hospital.
Trial summary
The purpose of this study is to test the effect of a moderate-intensity aerobic exercise intervention for smokers interested in quitting smoking. We expect that this project will contribute much needed knowledge about the role of aerobic exercise in smoking cessation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- aerobic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- No sites listed yet
- Study dates
- Apr 2006to Mar 2012
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- are between 18 and 65 years of age
- are current smokers (i.e., smoking at least 10 cigarettes per day)
- are sedentary, i.e., have not participated regularly in aerobic physical exercise (for at least 20 minutes per day, 3 days per week) for the past six months.
Who cannot join
- current DSM-IV Axis I psychiatric disorder as assessed by SCID-NP
- Substance abuse or dependence (excluding nicotine dependence) within the past 6 months
- lifetime DSM-IV diagnosis of a bipolar disorder as assessed by the SCID-NP
- lifetime history of a psychotic disorder or current psychotic symptoms as assessed by the SCID-NP
- current suicidality or homicidality
- marked organic impairment
- physical disabilities or medical problems (such as a history of diabetes, hypertension, seizure disorder, coronary heart disease, valvular heart disease, and pulmonary disease) or use of medications (such as beta blockers) that would prevent or hinder participation in a program of moderate intensity exercise
- current pregnancy of intent to become pregnant during the next 12 weeks, and i) current use of any pharmacotherapy, including transdermal nicotine replacement, for smoking cessation
About this study
The purpose of this study is to test the effect of a moderate-intensity aerobic exercise intervention for smokers interested in quitting smoking. We expect that this project will contribute much needed knowledge about the role of aerobic exercise in smoking cessation. If the efficacy of moderate-intensity, aerobic exercise for smoking can be established, smokers may have a valuable adjunct to more traditional smoking cessation approaches.
- Conditions
- Nicotine Dependence
- Being tested
- aerobic exercise, Health Education Control
- Keywords
- smoking cessation, exercise, physical activity, health education
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation, Motor Activity, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exerciseBehavioural
12-week moderate intensity behavioral exercise intervention (MIBE) AND a 12-week standard smoking cessation program (including transdermal nicotine patch)
Health Education ControlBehavioural
12-week health education control (HEC) AND a 12-week standard smoking cessation program (including transdermal nicotine patch).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 12-week moderate intensity behavioral exercise intervention (MIBE) AND a 12-week standard smoking cessation program (including transdermal nicotine patch) Receives: Behavioral: aerobic exercise |
| 2 | Active comparator | 12-week health education control (HEC) AND a 12-week standard smoking cessation program (including transdermal nicotine patch). Receives: Behavioral: Health Education Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported smoking abstinence via Timeline Followback (TLFB)
Measured: 12-months
Biochemically verified smoking abstinence via carbon monoxide and saliva cotinine
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2008 (estimated)
- Study startApr 2006
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Ana Abrantes, PhD, Principal investigator, Butler Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00713063
- Sponsor's protocol ID
- 0603-01
- Other IDs
- 5K23DA019950
- Status last verified
- Jan 2015
- First submitted
- 9 Jul 2008
- Last updated
- 30 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Exercise Intervention for Smoking Cessation
- ClinicalTrials.gov ID
- NCT00713063
- Acronym / sponsor ID
- 0603-01
- Conditions
- Nicotine Dependence
- Keywords
- smoking cessation, exercise, physical activity, health education
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Apr 2006
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 11 Jul 2008 (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 purpose of this study is to test the effect of a moderate-intensity aerobic exercise intervention for smokers interested in quitting smoking. We expect that this project will contribute much needed knowledge about the role of aerobic exercise in smoking cessation. If the efficacy of moderate-intensity, aerobic exercise for smoking can be established, smokers may have a valuable adjunct to more traditional smoking cessation approaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: aerobic exercise12-week moderate intensity behavioral exercise intervention (MIBE) AND a 12-week standard smoking cessation program (including transdermal nicotine patch) |
| 2 | Active comparator | Behavioral: Health Education Control12-week health education control (HEC) AND a 12-week standard smoking cessation program (including transdermal nicotine patch). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- are between 18 and 65 years of age
- are current smokers (i.e., smoking at least 10 cigarettes per day)
- are sedentary, i.e., have not participated regularly in aerobic physical exercise (for at least 20 minutes per day, 3 days per week) for the past six months.
Key exclusion criteria (8 listed)
- current DSM-IV Axis I psychiatric disorder as assessed by SCID-NP
- Substance abuse or dependence (excluding nicotine dependence) within the past 6 months
- lifetime DSM-IV diagnosis of a bipolar disorder as assessed by the SCID-NP
- lifetime history of a psychotic disorder or current psychotic symptoms as assessed by the SCID-NP
- current suicidality or homicidality
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 |
|---|---|---|
| aerobic exercise12-week moderate intensity behavioral exercise intervention (MIBE) AND a 12-week standard smoking cessation program (including transdermal nicotine patch) | Behavioural | 1 |
| Health Education Control12-week health education control (HEC) AND a 12-week standard smoking cessation program (including transdermal nicotine patch). | Behavioural | 2 |
Primary outcome
Self-reported smoking abstinence via Timeline Followback (TLFB)
Time frame: 12-months
Biochemically verified smoking abstinence via carbon monoxide and saliva cotinine
Time frame: 12 Months
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 30 Jan 2015.
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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.
Ana Abrantes, PhD principal investigator
Butler Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing aerobic exercise in people with Nicotine Dependence, run by Butler Hospital.
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 3 inclusion and 8 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 30 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Self-reported smoking abstinence via Timeline Followback (TLFB) (time frame: 12-months). 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?
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 30 Jan 2015.