Nicotine DependenceNCT00921388
Exercise or Relaxation for Smoking Cessation
A study testing Varenicline and smoking cessation counseling and Exercise or relaxation treatment in people with Nicotine Dependence and Smoking Cessation, run by UConn Health at 2 sites in United States.
Trial summary
This research study is being done to find out if adding a moderate exercise program or a relaxation program to a smoking cessation treatment program will improve smoking cessation and health in postmenopausal women. Read more about this study
- Who is it for?
- Ages 45 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence, Smoking Cessation
- What is being tested?
- Varenicline and smoking cessation counseling and Exercise or relaxation treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 301 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2009to 29 Aug 2017
- 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 45 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal women at least 45 years of age
- Smoking at least 10 cigarettes per day
- Motivated to quit smoking
- Ambulatory
- Currently exercising for 90 minutes of moderate exercise or less per week
- Motivated to exercise
- Permission from Primary Care Provider
- Good general health
Who cannot join
- Denied medical clearance from primary care provider
- Unstable angina or uncompensated heart failure
- Systolic blood pressure greater than 165 or diastolic blood pressure greater than 100
- Heart attack or stroke within the preceding 6 months
- Hip fracture within the preceding 6 months
- Unstable medical or psychiatric disorder (e.g., current major depressive disorder or substance abuse or dependence)
Show all 13Show fewer
- Exercise-exacerbated neuromuscular disorder
- Treatment for depression within the last year
- Estimated creatinine clearance of less than 30cc/minute
- Current use of a smoking cessation aid (i.e., bupropion, NRT, clonidine)
- Current use of psychotropic medication for a psychiatric problem
- Prescription narcotic abuse or dependence with the exception of people that have been stabilized on Methadone Maintenance or Suboxone
- Previous serious adverse event with Chantix use
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Connecticut Health Center
Farmington, Connecticut, 06030
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Exercise for Smoking Cessation in Postmenopausal Women
This research study is being done to find out if adding a moderate exercise program or a relaxation program to a smoking cessation treatment program will improve smoking cessation and health in postmenopausal women. We hope to learn which group is more successful at quitting, has less symptoms of withdrawal from smoking and has improved health.
Read the detailed description
Prevalence of smoking among women has declined more slowly in women than among men. Women who quit smoking substantially reduce the risk of premature death. A multi-modal approach to smoking cessation with combined behavioral and pharmacological interventions generally yields the highest success rates. The majority of subjects who are able to achieve abstinence return to smoking. Smoking relapse rates are 50-80% within one year with the majority of smokers relapsing within the first 3 months. Interventions are needed to both enhance smoking cessation rates and prevent relapse rates in order to substantially impact long-term quit rates.We intend to compare the effectiveness of a smoking cessation program combined with a moderate exercise program to an identical smoking cessation program combined with a relaxation-meditation control condition.
In a substudy, we will also evaluate the effectiveness of the intervention in premenopausal women (N=40)
- Conditions
- Nicotine Dependence, Smoking Cessation
- Being tested
- Varenicline and smoking cessation counseling, Exercise or relaxation treatment
- Keywords
- Smoking Cessation, Exercise, Postmenopausal women, CHANTIX, varenicline
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Varenicline and smoking cessation counselingOther
Also called CHANTIX
All subjects receive smoking cessation counseling and varenicline 0.5mg daily for three days then twice a day for the next four days; then 1 mg twice a day for 11 weeks. Counseling is integrated within the exercise or relaxation treatment program.
Exercise or relaxation treatmentBehavioural
Also called exercise program
One hour exercise sessions twice a week for 8 weeks, then once a week for 8 weeks, then once every other week for 4 weeks. Subjects in the control group receive a relaxation program that controls for contact time.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Exercise program Receives: Other: Varenicline and smoking cessation counseling; Behavioral: Exercise or relaxation treatment |
| 2 | Other | Relaxation program Receives: Other: Varenicline and smoking cessation counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate whether adding an established moderate resistance/aerobic exercise program for postmenopausal women 45 years of age and older to a standard smoking cessation treatment program improves short and long term smoking outcomes.
Measured: Week 12 and Week 64
Secondary outcomes (1)
To examine the main and interactive effects of history of depression and exercise on smoking cessation treatment.
Measured: Week 12 and Week 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2009 (estimated)
- Study startMar 2009
- Primary completion29 Aug 2017
- Study completion29 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Cheryl A Oncken, MD MPH, Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00921388
- Sponsor's protocol ID
- 09-097-2
- Other IDs
- 1R01DA024872-01A1
- Status last verified
- Oct 2017
- First submitted
- 15 Jun 2009
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.
PubMed 34611902
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise for Smoking Cessation in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT00921388
- Acronym / sponsor ID
- 09-097-2
- Conditions
- Nicotine Dependence, Smoking Cessation
- Keywords
- Smoking Cessation, Exercise, Postmenopausal women, CHANTIX, varenicline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Study start
- Mar 2009
- Primary completion
- 29 Aug 2017 (actual)
- Study completion
- 29 Aug 2017 (actual)
- First posted
- 16 Jun 2009 (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.
This research study is being done to find out if adding a moderate exercise program or a relaxation program to a smoking cessation treatment program will improve smoking cessation and health in postmenopausal women. We hope to learn which group is more successful at quitting, has less symptoms of withdrawal from smoking and has improved health.
Detailed description
Prevalence of smoking among women has declined more slowly in women than among men. Women who quit smoking substantially reduce the risk of premature death. A multi-modal approach to smoking cessation with combined behavioral and pharmacological interventions generally yields the highest success rates. The majority of subjects who are able to achieve abstinence return to smoking. Smoking relapse rates are 50-80% within one year with the majority of smokers relapsing within the first 3 months. Interventions are needed to both enhance smoking cessation rates and prevent relapse rates in order to substantially impact long-term quit rates.We intend to compare the effectiveness of a smoking cessation program combined with a moderate exercise program to an identical smoking cessation program combined with a relaxation-meditation control condition.
In a substudy, we will also evaluate the effectiveness of the intervention in premenopausal women (N=40)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Varenicline and smoking cessation counseling, Behavioral: Exercise or relaxation treatmentExercise program |
| 2 | Other | Other: Varenicline and smoking cessation counselingRelaxation program |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Postmenopausal women at least 45 years of age
- Smoking at least 10 cigarettes per day
- Motivated to quit smoking
- Ambulatory
- Currently exercising for 90 minutes of moderate exercise or less per week
Key exclusion criteria (13 listed)
- Denied medical clearance from primary care provider
- Unstable angina or uncompensated heart failure
- Systolic blood pressure greater than 165 or diastolic blood pressure greater than 100
- Heart attack or stroke within the preceding 6 months
- Hip fracture within the preceding 6 months
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 |
|---|---|---|
| Varenicline and smoking cessation counselingAlso: CHANTIXAll subjects receive smoking cessation counseling and varenicline 0.5mg daily for three days then twice a day for the next four days; then 1 mg twice a day for 11 weeks. Counseling is integrated within the exercise or relaxation treatment program. | Other | 1, 2 |
| Exercise or relaxation treatmentAlso: exercise programOne hour exercise sessions twice a week for 8 weeks, then once a week for 8 weeks, then once every other week for 4 weeks. Subjects in the control group receive a relaxation program that controls for contact time. | Behavioural | 1 |
Primary outcome
To evaluate whether adding an established moderate resistance/aerobic exercise program for postmenopausal women 45 years of age and older to a standard smoking cessation treatment program improves short and long term smoking outcomes.
Time frame: Week 12 and Week 64
1 secondary outcome
To examine the main and interactive effects of history of depression and exercise on smoking cessation treatment.
Time frame: Week 12 and Week 64
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 31 Oct 2017.
- Derived from this study: PubMed 34611902Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.
- Individual participant dataSharing planned: No
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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.
Cheryl A Oncken, MD MPH principal investigator
UConn Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Varenicline and smoking cessation counseling and Exercise or relaxation treatment in people with Nicotine Dependence and Smoking Cessation, run by UConn Health at 2 sites 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 13 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 31 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
To evaluate whether adding an established moderate resistance/aerobic exercise program for postmenopausal women 45 years of age and older to a standard smoking cessation treatment program improves short and long term smoking outcomes. (time frame: Week 12 and Week 64). 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 NCT00921388, which also lists 1 linked publication.
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 31 Oct 2017; AzTrials last refreshed its copy on 30 Oct 2026.