Smoking CessationNCT02055326
Yoga for Men Attempting Smoking Cessation
A study testing Cognitive Behavioral Therapy for Smoking Cessation, Yoga and Health & Wellness in people with Smoking Cessation, run by The Miriam Hospital at 1 site in United States.
Trial summary
The purpose of this pilot study is to examine the feasibility and preliminary efficacy of a quit-smoking program that combines behavioral therapy with either yoga, or a health \& wellness program that serves as a contact control. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Cognitive Behavioral Therapy for Smoking Cessation, Yoga and Health & Wellness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jul 2011
- 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male
- age 18 -65
- daily smoker, 5 or more cigarettes/day
- generally healthy
- able to exercise safely
Who cannot join
- female
- hypertension
- current or recent history of medication use for major depression
- participation in yoga classes within the past year
- current or >1 year prior experience with mind/body therapies
- currently participating in regular exercise classes
- currently enrolled in quit smoking program
- currently using quit smoking medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Complementary Treatments for Smoking Cessation
The purpose of this pilot study is to examine the feasibility and preliminary efficacy of a quit-smoking program that combines behavioral therapy with either yoga, or a health \& wellness program that serves as a contact control.
Read the detailed description
Men enrolled in this pilot will be provided with 8 weeks of cognitive-behavioral therapy for smoking cessation and either 1) a twice-weekly program of yoga, or 2) a health \& wellness program that serves as a control for number of contacts and subject burden between study conditions. Qualitative data from open ended surveys and interviews is used to supplement survey data to enhance the investigators understanding of study outcomes. Participant accrual and retention rates, acceptance of randomization, and compliance with study protocols will be examined along with perceptions and beliefs about yoga and its relationship to quitting smoking specifically, and health in general.
- Conditions
- Smoking Cessation
- Being tested
- Cognitive Behavioral Therapy for Smoking Cessation, Yoga, Health & Wellness
- Keywords
- Smoking, yoga, men, intervention
- Medical subject headings
- Smoking Cessation, Smoking, Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for Smoking CessationBehavioural
one hour weekly for 8 weeks. Cognitive behavioral therapy for smoking cessation
YogaBehavioural
One hour, twice weekly for 8 weeks of vinyasa yoga
Health & WellnessBehavioural
Lectures, handouts and printed materials on general health and wellness topics including healthy eating, cancer prevention and cardiovascular disease prevention.
| Study group | Role | What they receive |
|---|---|---|
| Yoga | Experimental | One-hour sessions of twice weekly yoga for 8 weeks. Receives: Behavioral: Cognitive Behavioral Therapy for Smoking Cessation; Behavioral: Yoga |
| Health & Wellness | Active comparator | 8 week program of health \& wellness classes, materials and handouts. Topics included healthy eating, cancer prevention and cardiovascular disease prevention. Receives: Behavioral: Cognitive Behavioral Therapy for Smoking Cessation; Behavioral: Health & Wellness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking abstinence
7-day point prevalence abstinence was measured at 8 weeks, 3 and 6 months follow up
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2014 (estimated)
- Study startSep 2009
- Primary completionFeb 2011
- Study completionJul 2011
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 Smoking CessationStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02055326
- Sponsor's protocol ID
- AT003669-02S1
- Status last verified
- Jan 2014
- First submitted
- 3 Feb 2014
- Last updated
- 5 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Jackson S, Brown J, Norris E, Livingstone-Banks J, Hayes E, Lindson N. Mindfulness for smoking cessation. Cochrane Database Syst Rev. 2022 Apr 14;4(4):CD013696. doi: 10.1002/14651858.CD013696.pub2.
PubMed 35420700
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complementary Treatments for Smoking Cessation
- ClinicalTrials.gov ID
- NCT02055326
- Acronym / sponsor ID
- AT003669-02S1
- Conditions
- Smoking Cessation
- Keywords
- Smoking, yoga, men, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Sep 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 5 Feb 2014 (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 pilot study is to examine the feasibility and preliminary efficacy of a quit-smoking program that combines behavioral therapy with either yoga, or a health \& wellness program that serves as a contact control.
Detailed description
Men enrolled in this pilot will be provided with 8 weeks of cognitive-behavioral therapy for smoking cessation and either 1) a twice-weekly program of yoga, or 2) a health \& wellness program that serves as a control for number of contacts and subject burden between study conditions. Qualitative data from open ended surveys and interviews is used to supplement survey data to enhance the investigators understanding of study outcomes. Participant accrual and retention rates, acceptance of randomization, and compliance with study protocols will be examined along with perceptions and beliefs about yoga and its relationship to quitting smoking specifically, and health in general.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga | Experimental | Behavioral: Cognitive Behavioral Therapy for Smoking Cessation, Behavioral: YogaOne-hour sessions of twice weekly yoga for 8 weeks. |
| Health & Wellness | Active comparator | Behavioral: Cognitive Behavioral Therapy for Smoking Cessation, Behavioral: Health & Wellness8 week program of health \& wellness classes, materials and handouts. Topics included healthy eating, cancer prevention and cardiovascular disease prevention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- male
- age 18 -65
- daily smoker, 5 or more cigarettes/day
- generally healthy
- able to exercise safely
Key exclusion criteria (8 listed)
- female
- hypertension
- current or recent history of medication use for major depression
- participation in yoga classes within the past year
- current or >1 year prior experience with mind/body therapies
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 |
|---|---|---|
| Cognitive Behavioral Therapy for Smoking Cessationone hour weekly for 8 weeks. Cognitive behavioral therapy for smoking cessation | Behavioural | Health & Wellness, Yoga |
| YogaOne hour, twice weekly for 8 weeks of vinyasa yoga | Behavioural | Yoga |
| Health & WellnessLectures, handouts and printed materials on general health and wellness topics including healthy eating, cancer prevention and cardiovascular disease prevention. | Behavioural | Health & Wellness |
Primary outcome
Smoking abstinence
Time frame: 7 days
7-day point prevalence abstinence was measured at 8 weeks, 3 and 6 months follow up
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 5 Feb 2014.
- Derived from this study: PubMed 35420700Jackson S, Brown J, Norris E, Livingstone-Banks J, Hayes E, Lindson N. Mindfulness for smoking cessation. Cochrane Database Syst Rev. 2022 Apr 14;4(4):CD013696. doi: 10.1002/14651858.CD013696.pub2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for Smoking Cessation, Yoga and Health & Wellness in people with Smoking Cessation, run by The Miriam Hospital 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 5 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 5 Feb 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?
Smoking abstinence (time frame: 7 days). 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 NCT02055326, 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 5 Feb 2014.